Synergy Health AST, SRL

FDA Device Registration & Listing · Alajuela, CR · Registration 3010273872

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010273872
FEI Number
3010273872
Entity Name
Synergy Health AST, SRL
City/State/Country
Alajuela, CR
Establishment Address
B13.1 Street 4, Avenue 1, Coyol Free Zone, Alajuela 20102, CR
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Synergy Health AST, LLC (Owner Number: 10028672)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Acclarent8881 (CR2) - RELIEVA TRACT Balloon Dilation System Arthocare8208 (CR2) - OSTEORAPTOR 2.9 W 1UB II BLUE Arthocare8208 (CR2) - OSTEORAPTOR 2.3 W 1UB II BLUE Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Triever16 Triever20 Triever24 Triever16 Curve Triever20 Curve" Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - ClotTriever Sheath 13Fr ClotTriever Sheath 16Fr Intri24 Introducer Sheath Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Triever16 Triever20 Triever24 Triever16 Curve Triever20 Curve Acclarent8881 (CR2) - Relieva Circa Ethmoid Punch Arthocare8208 (CR2) - NOVOSTITCH PRO Arthocare8208 (CR2) - ULTRAbutton Adjustable Fixation Device Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - ClotTriever Catheter, 16mm ClotTriever BOLD Catheter ClotTriever XL Catheter Venacore Thrombectomy Acclarent8881 (CR2) - TruDi NAVWIRE Sinus Navigation Guidewire Acclarent8881 (CR2) - TruDi Probe Zimmer (CR2) - A.T.S. Arthocare8208 (CR2) - MNITAC 2 MM TITANIUM WITH 2 ULTRABRAID SUTURES SIZE 2-0 AND NEEDLES Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Arthocare8208 (CR2) - MICRORAPTOR REGENESORB Suture Anchor with ONE ULTRABRAID (#1) Suture (Blue) Arthocare8208 (CR2) - MICRORAPTOR REGENESORB Suture Anchor with ONE ULTRABRAID (#1) Suture (blue Cobraid) Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - FlowTriever Catheter 6-10mm FlowTriever Catheter11-14mm FlowTriever Catheter 15-18mm FlowTriever Cath Shockwave7578 (CR1,PT) - Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter Arthocare8208 (CR2) - NOVOSTITCH PRO Arthocare8208 (CR2) - MOSAICPLASTY DP-DISP. 3.5MM 4.5MM, 6.5MM, 8.5MM Inari11106 (CR2) - Artix™ Thin-Walled Thrombectomy Sheath Arthocare8208 (CR2) - HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE Arthocare8208 (CR2) - HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD Arthocare8208 (CR2) - HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL Arthocare8208 (CR2) - HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD Arthocare8208 (CR2) - NasaStent Arthocare8208 (CR2) - PerfectPasser Connector Suturing Device Arthocare8208 (CR2) - SmartStitch Perfectpasser MagnumWire Suture Cartridge (Blue Co-braid) 6-pack Arthocare8208 (CR2) - PerfectPasser Connector MagnumWire (Mixed White & Blue Cobraid) Suture Cartridge, Arthocare8208 (CR2) - SmartStitch Perfectpasser MagnumWire Suture Cartridge (Black Co-braid) 6-pack Arthocare8208 (CR2) - SmartStitch Perfectpasser MagnumWire Suture Cartridge (White) 6-pack Arthocare8208 (CR2) - TWINFIX TITANIUM 3.5 MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURES No.2 AND NEEDLES, SL Arthocare8208 (CR2) - 1.8 mm Q-Fix Soft Suture Anchor Arthocare8208 (CR2) - 1.8mm Q-Fix Mini Soft Suture Anchor Arthocare8208 (CR2) - 2.8 mm Q-Fix Soft Suture Anchor Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - ClotTriever Catheter16mm ClotTriever BOLD Catheter ClotTriever XL Catheter Venacore Thrombectomy Ca Arthocare8208 (CR2) - ULTRA FAST-FIX AB Straight Needle Delivery System Arthocare8208 (CR2) - HEALICOIL RG 4.75MM W2 MT BL/CB WH Arthocare8208 (CR2) - RAPTORMITE 3.7 AB W/NDL 20 ULTRABRAID Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM HIDROXYAPATITE ANCHOR WITH Arthocare8208 (CR2) - RAPTORMITE 3 PK W/NDL 2 0 ULTRABRA Arthocare8208 (CR2) - TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - OSTEORAPTOR CURVED 2.3 PLLA/HA SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLACK Arthocare8208 (CR2) - OSTEORAPTOR 2.3 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLACK Arthocare8208 (CR2) - TWINFIX ULTRA 4.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH Arthocare8208 (CR2) - OSTEORAPTOR 2.9 W/ 1 UB WHITE Arthocare8208 (CR2) - HEALICOIL RG 5.5MM W3 MT BL/CB WH/CB BL Arthocare8208 (CR2) - TWINFIX ULTRA 4.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE Arthocare8208 (CR2) - OSTEORAPTOR 2.3 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLUE Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE Arthocare8208 (CR2) - TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLE Arthocare8208 (CR2) - HEALICOIL REGENESORB 5.5mm Suture Anchor with two ULTRABRAID (#2) sutures (blue/cobraid blue) Arthocare8208 (CR2) - OSTEORAPTOR CURVED 2.3 PLLA/HA SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE Arthocare8208 (CR2) - HEALICOIL RG 4.75MM W3 MT BL/CB WH/CB BL Arthocare8208 (CR2) - OSTEORAPTOR 2.9 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLUE Arthocare8208 (CR2) - HEALICOIL RG 5.5MM W2 MT BL/CB WH Arthocare8208 (CR2) - TWINFIX ULTRA 5.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH Arthocare8208 (CR2) - TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH Arthocare8208 (CR2) - TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE Arthocare8208 (CR2) - Three ULTRABRAID (#2) Sutures (Blue/Cobraid Blue/Cobraid Black) Arthocare8208 (CR2) - OSTEORAPTOR 2.3 W 1UB II BLUE Arthocare8208 (CR2) - TWINFIX ULTRA 4.5 MM HIDROXYAPATITE ANCHOR WITH Arthocare8208 (CR2) - THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH Arthocare8208 (CR2) - OSTEORAPTOR 2.9 SUTURE ANCHOR WITH TWO ULTRABRAID No.2 SUTURE WHITE/COBRAID BLUE Arthocare8208 (CR2) - ULTRA FAST-FIX AB ASSEMBLY - REVERSE CURVED Arthocare8208 (CR2) - HEALICOIL REGENESORB 4.75mm Suture Anchor with Two ULTRABRAID (#2) Sutures (Blue/Cobraid Blue) Arthocare8208 (CR2) - OSTEORAPTOR 2.9 SUTURE ANCHOR WITH TWO ULTRABRAID No.2 SUTURE WHITE/COBRAID BLACK Arthocare8208(CR2)-TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK Arthocare8208 (CR2) - HEALICOIL REGENESORB 5.5mm Suture Anchor with Arthocare8208 (CR2) - ULTRA FAST-FIX AB ASSEMBLY – CURVED Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - FlowSaver FlowSaver Blood Retrun System Arthocare8208 (CR2) - DYNOMITE 2 MM PEEK WITH 1 ULTRABRAID SUTURE SIZES 2-0 AND NEEDLES Arthocare8208 (CR2) - SPYROMITE 2 MM PEEK WITH 1 ULTRABRAID SUTURE SIZES 2-0 NEEDLES Acclarent8881 (CR2) - RELIEVA SIDEKICK Low Profile Acclarent8881 (CR2) - RELIEVA FLEX Sinus Guide Catheter Acclarent8881 (CR2) - Relieva Flex Guide Catheter Acclarent8881 (CR2) - Relieva Sidekick LP Arthocare8208 (CR2) - HEALICOIL KNOTLESS REGENESORB Suture Anchor, 5.5mm Arthocare8208 (CR2) - HEALICOIL Knotless PK Suture Anchor, 5mm, Self-Tapping Arthocare8208 (CR2) - HEALICOIL Knotless PK Suture Anchor, 5mm Arthocare8208 (CR2) - HEALICOIL KNOTLESS REGENESORB Suture Anchor, 5.5mm, Self-Tapping Inari11106 (CR2) -ClotTriever Catheter, 16mm ClotTriever BOLD Catheter ClotTriever XL Catheter VenacoreThrombectomyCat Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Triever16 Triever20 Triever24 Triever16 Curve Triever20 Curve BSCI (CR2) - "NephroMax and NephroMax Kit" Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - ClotTriever Catheter, 16mm ClotTriever BOLD Catheter ClotTriever XL Catheter Venacore Thrombectomy Inari11106 (CR2) - FlowStasis FlowStasis 3 Pack FlowStasis Suture Retention Device Terumo2207 (CR2) - Spectra Optia® Apheresis System Arthocare8208 (CR2) - GUHL ANKLE DISTRACTOR FOOT STRAPS, STERILE, LATEX FREE BOX OF 6 Inari11106 (CR2) - Triever16 Triever20 Triever24 Triever16 Curve Triever20 Curve Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Arthocare8208 (CR2) - TWINFIX ULTRA PK 6.5MM BLUE/WHTE & BLUE Arthocare8208 (CR2) - TWINFIX ULTRA PK 5.5MM BLUE/WHTE & BLUE Arthocare8208 (CR2) - TWINFIX ULTRA PK 4.5MM BLUE/WHTE & BLUE Acclarent8881 (CR2) - TruDi Probe Inari11106 (CR2) - Artix AX Artix BG Artix™ MT Artix Thrombectomy Device Arthocare8208 (CR2) - SUTUREFIX ULTRA AHR S 2 UB STR CB BLU Arthocare8208 (CR2) - SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL Arthocare8208 (CR2) - SUTUREFIX UL ANR XL W/1 2 ULTRABRIAD BL Arthocare8208 (CR2) - SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH Arthocare8208 (CR2) - SUTUREFIX ULTRA AHR S 2 UB STR BLUE Arthocare8208 (CR2) - SpeedLock HIP Knotless Fixation Device Acclarent8881 (CR2) - RELIEVA SCOUT Multi-Sinus Dilation System Inari11106 (CR2) - ClotTriever Sheath 13Fr ClotTriever Sheath 16Fr Intri24 Introducer Sheath " Arthocare8208 (CR2) - Collagen Tendon Sheet-DDI Arthocare8208 (CR2) - BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB WTE Arthocare8208 (CR2) - BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB BLK Arthocare8208 (CR2) - BIORPTR 2.3 PK SUTR ANCR ONE 38 C/B BK Arthocare8208 (CR2) - RAPTORMITE 3 PK W/NDL 2 0 ULTRABRA Arthocare8208 (CR2) - BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB Arthocare8208 (CR2) - BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL Revelle14591 (CR2) - Aveli BSCI (CR2) - SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Cable BSCI (CR2) -POLARx FIT Cryoablation Balloon Catheter [Short Tip (ST)] POLARx FIT Cryoablation Balloon Catheter [Long Tip BSCI (CR2) - POLARx Cryoablation Balloon Catheter [Short Tip (ST)] POLARx Cryoablation Balloon Catheter [Long Tip (LT)] Viant8257 (CR2) - Wound Debridement System Zimmer (CR2) - Pulsavac Arthocare8208 (CR2) - SpeedLock Knotless Fixation Device Inari11106 (CR2) - FlowTriever Catheter 6-10mm FlowTriever Catheter11-14mm FlowTriever Catheter 15-18mm FlowTriever Cath Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Acclarent8881 (CR2) - RELIEVA LUMA SENTRY Sinus Illumination System Inari11106 (CR2) - ClotTriever Sheath 13Fr ClotTriever Sheath 16Fr Intri24 Introducer Sheath Arthocare8208 (CR2) - CAP-LIFT Cannula, 90mm Arthocare8208 (CR2) - RITEFIT Cannula, 10mm Arthocare8208 (CR2) - CAP-LIFT Cannula, 80mm Arthocare8208 (CR2) - CAP-LIFT Cannula, 110mm Arthocare8208 (CR2) - RITEFIT Cannula, 6mm Arthocare8208 (CR2) - CAP-LIFT Cannula, 70mm Arthocare8208 (CR2) - CAP-LIFT Cannula, 100mm Arthocare8208 (CR2) - RITEFIT Cannula, 8mm Arthocare8208 (CR2) - ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, MEDIUM Arthocare8208 (CR2) - ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, SMALL Arthocare8208 (CR2) - ULTRABUTTON BB BONE BLOCK ADJUSTABLE FIXATION DEVICE Arthocare8208 (CR2) - ULTRABUTTON QUAD Adjustable Fixation Device Arthocare8208 (CR2) - ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, LARGE Acclarent8881 (CR2) - TruDi Curette Arthocare8208 (CR2) - FAST-FIX FLEX Reverse Curved Inserter Arthocare8208 (CR2) - FAST-FIX FLEX Curved Inserter Arthocare8208 (CR2) - FAST-FIX FLEX CURVED INSERTER Arthocare8208 (CR2) - FAST-FIX FLEX REVERSE CURVED INSERTER Arthocare8208 (CR2) - Magnum 2 Knotless Implant Acclarent8881 (CR2) - ACCLARENT PIVOT™ Navigation Balloon Dilation System Acclarent8881 (CR2) - ACCLARENT PIVOT Balloon Dilation Systems Arthocare8208 (CR2) - HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH Arthocare8208 (CR2) - HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK Arthocare8208 (CR2) - HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH Arthocare8208 (CR2) - ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2 Arthocare8208 (CR2) - ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE Inari11106 (CR2) - "ClotTriever Catheter, 16mm ClotTriever BOLD Catheter ClotTriever XL Catheter Venacore Thrombectomy Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Arthocare8208 (CR2) - FOOTPRINT MINI Drill, 3.7mm Arthocare8208 (CR2) - FOOTPRINT MINI Drill, 3.5mm Arthocare8208 (CR2) - FOOTPRINT MINI PK, 3.5mm StJude3293 (CR2) - AMPLATZER Septal Occluder (ASO) Acclarent8881 (CR2) - AERA Eustachian Tube Balloon Dilation System Acclarent8881 (CR2) - RELIEVA SPINPLUS Balloon Sinuplasty System Inari11106 (CR2) - ClotTriever Catheter, 16mm ClotTriever BOLD Catheter ClotTriever XL Catheter VenacoreThrombectomyCa Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Artix™ Thin-Walled Thrombectomy Sheath Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Acclarent8881 (CR2) - Acclarent NavWire Arthocare8208 (CR2) - MICRORAPTOR KNOTLESS SA PEEK Arthocare8208 (CR2) - MICRORAPTOR KNOTLESS SA RGNSB Arthocare8208 (CR2) - TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 Arthocare8208 (CR2) - PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULT Arthocare8208 (CR2) - TWINFIX 2.8 MM TITANIUM SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, STERILE Arthocare8208 (CR2) - TWINFIX ULTRA 4.5 MM PK ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM PK ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE Arthocare8208 (CR2) - TWINFIX ULTRA PK 6.5MM BLUE/WHTE & BLUE Arthocare8208 (CR2) - HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) Arthocare8208 (CR2) - HEALICOIL SA PK 5.5mm W/2 UB-BL, CBRD BL Arthocare8208 (CR2) - TWINFIX ULTRA 4.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL Arthocare8208 (CR2) - HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE) Arthocare8208 (CR2) - TWINFIX ULTRA 5.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - BIORAPTOR 2.3 PK Arthocare8208 (CR2) - TWINFIX ULTRA PK 5.5MM BLUE/WHTE & BLUE Arthocare8208 (CR2) - TWINFIX ULTRA 4.5MM W/2 UB (BLK &BLUE) Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM PK ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES, STERILE Arthocare8208 (CR2) - TWINFIX ULTRA 6.5MM W/3 UB Arthocare8208 (CR2) - TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE) Arthocare8208 (CR2) - No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULT Arthocare8208 (CR2) - TWINFIX ULTRA TI 5.5 W/3 UB Arthocare8208 (CR2) - TWINFIX ULTRA 6.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - TWINFIX 5 MM TITANIUM SUTURE ANCHOR WITH TWO Arthocare8208 (CR2) - BIORAPTOR Curved 2.3 PK Arthocare8208 (CR2) - TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE) Arthocare8208 (CR2) - HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT Arthocare8208 (CR2) - TWINFIX ULTRA 5.5 MM PK ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE Arthocare8208 (CR2) - TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE) Arthocare8208 (CR2) - TWINFIX ULTRA PK 4.5MM BLUE/WHTE & BLUE Arthocare8208 (CR2) - HEALICOIL PK 4.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) Arthocare8208 (CR2) - FAST-FIX 360 CURVED NDL DELIVERY SYSTEM Arthocare8208 (CR2) - ULTRA FAST-FIX ASSEMBLY – STRAIGHT Arthocare8208 (CR2) - ULTRA FAST-FIX ASSEMBLY – CURVED Arthocare8208 (CR2) - FAST-FIX 360 REVERSE CURVE NDL DELIVERY SYSTEM Arthocare8208 (CR2) - FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM Arthocare8208 (CR2) - ULTRA FAST-FIX ASSY – REVERSE CURVE BSCI (CR1) - Spyglass Retrieval Snare Inari11106 (CR2) - Artix™ Thin-Walled Thrombectomy Sheath Arthocare8208 (CR2) - HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) Arthocare8208 (CR2) - ULTRABRIDGE Drill, 4mm Arthocare8208 (CR2) - ULTRABRIDGE Kit Arthocare8208 (CR2) - HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue) Shockwave7578 (PT, SDB) - Lithoplasty Peripheral Balloon Dilatation Catheter Acclarent8881 (CR2) - TruDi NAV Cable Acclarent8881 (CR2) - RELIEVA SPINPLUS NAV Balloon Sinuplasty System Acclarent8881 (CR2) - Relieva SpinPlus Balloon Sinuplasty System Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 10MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 45MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 30MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 15MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 60MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 50MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 25MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 55MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 40MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 35MM Arthocare8208 (CR2) - ENDOBUTTON CL ULTRA 20MM BSCI (CR1) -Escape Nitinol Stone Retrieval Basket Gemini Paired Wire Helical Stone Retrieval Basket Graspit Nitinol Ston Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Arthocare8208 (CR2) - QUADTRAC Disposable Kit Arthocare8208 (CR2) - 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE) Arthocare8208 (CR2) - 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) Arthocare8208 (CR2) - 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE) Acclarent8881 (CR2) - INSPIRA AIR Balloon Dilation System Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Inari11106 (CR2) - Triever16 Triever20 Triever24 Triever16 Curve Triever20 Curve Inari11106 (CR2) - Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-pack" Arthocare8208 (CR2) - SUTUREFIX CRV AHR S 2 #1 UB STR BL BL-CB Arthocare8208 (CR2) - SUTUREFIX CRVD AHR XL 1 #2 UB STR BL Arthocare8208 (CR2) - SUTUREFIX CRVD AHR XL 1 #2 UB STR BL-CB Arthocare8208 (CR2) - SUTUREFIX CRVD AHR S 1 #2 UB STR BL Arthocare8208 (CR2) - SUTUREFIX CRVD AHR S 1 #2 UB STR BL-CB

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2023-04-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-04-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-01-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-01-15
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-25
QGK Balloon, Nasal Airway Ear, Nose, Throat Class 1 874.4420 2019-05-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-10-15
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2024-10-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-11-22
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-11-22
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-09
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2015-05-08
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2015-05-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-09-12
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-12-21
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-27
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2023-07-31
MGZ Valvulotome Cardiovascular Class 2 870.4885 2024-05-28
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-15
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-25
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2021-06-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-25
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-04-27
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2023-04-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-04-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-11
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-11
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2023-04-24
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2023-04-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
KAX Punch, Ethmoid Ear, Nose, Throat Class 1 874.4420 2019-05-16
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-25
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-24
IZD Probe, Uptake, Nuclear Radiology Class 1 892.1320 2023-06-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
NGV System, Appendage Closure, Left Atrial Unknown Class 3 N/A 2023-07-31
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2023-04-27
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-16
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2023-07-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2022-05-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-15
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2021-03-16
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-03-16
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-26
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2023-04-26
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-04-27
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2023-07-31
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-27
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2014-07-24
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-08-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-14
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-14
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-27
SCN Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief Neurology Class 2 882.5870 2026-05-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-04-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-08-26
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2022-08-26
PPN Percutaneous Catheter, Ultrasound Cardiovascular Class 2 870.1250 2021-12-22
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2018-05-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-25
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-05-08
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-04-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-04-27
QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown Class 3 N/A 2024-10-15
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2023-04-27
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2023-04-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-10-28
HRX Arthroscope Orthopedic Class 2 888.1100 2025-11-24
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-11-24
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2022-05-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-08-11
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-11
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2023-04-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-26
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-04-27
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-04-27
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2024-05-28
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2023-04-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-27
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-04-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2023-04-25
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2018-05-17
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2018-05-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-25
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2019-05-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2023-04-25
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-04-25
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-27
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2023-04-27
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2025-08-11
PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse Obstetrics/Gynecology Class 2 884.4910 2023-04-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-25
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2023-04-27
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2023-04-27
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-27
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2019-05-16
PPN Percutaneous Catheter, Ultrasound Cardiovascular Class 2 870.1250 2020-02-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-11-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2023-07-31
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-26
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2012-11-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2021-04-12
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-08-02
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2015-05-08
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-09-18
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-09-18
MIR Shunt, Portosystemic, Endoprosthesis Unknown Class 3 N/A 2023-04-26
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
PND Midline Catheter General Hospital Class 2 880.5200 2025-07-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-09
LJE Catheter, Nephrostomy Unknown Class U N/A 2023-04-25
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-07-31
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2023-04-25
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2023-04-25
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2023-04-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-27
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-04-25
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2025-07-02
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-26
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2025-08-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-04-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-04-27
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2023-04-27
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 2025-11-24
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2023-04-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-05-12
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-09-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-25
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2026-03-30
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2019-06-04
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
DRC Trocar Cardiovascular Class 2 870.1390 2023-04-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
NIO Stent, Iliac Unknown Class 3 N/A 2023-07-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-04-04
EYK Connector, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2023-08-03
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-11-22
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2023-04-25
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2019-05-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-25
FQH Lavage, Jet General Hospital Class 2 880.5475 2020-10-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-11
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2023-04-27
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2023-04-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-27
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2024-10-28
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-03-16
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2021-03-16
FAE Prosthesis, Penile Gastroenterology, Urology Class 2 876.3630 2023-04-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-11-22
ORQ Mesh, Surgical, Deployer General, Plastic Surgery Class 2 878.3300 2021-01-04
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2021-01-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-09-15
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2023-08-31
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite General, Plastic Surgery Class 2 878.4790 2023-08-31
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-08-31
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2019-05-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-04-04
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2023-08-14
NIN Stent, Renal Unknown Class 3 N/A 2015-05-08
FQH Lavage, Jet General Hospital Class 2 880.5475 2016-09-27
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-04-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2023-07-31
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2019-06-17
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-11
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2025-09-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-09-18
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2025-12-05
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2025-12-05
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2023-04-27
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2023-04-27
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-08-02
MAF Stent, Coronary Unknown Class 3 N/A 2023-07-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2023-04-27
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-09-11
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2023-04-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2020-09-11
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2020-09-11
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-09-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-09
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-04-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-11-24
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-04-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-06-12
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-11-22
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-09-24
PNB Biliary Stent System For Benign Strictures Gastroenterology, Urology Class 2 876.5011 2023-04-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-25
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2023-04-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2023-04-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-01-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-01-15
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-27
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2023-07-31
NGV System, Appendage Closure, Left Atrial Unknown Class 3 N/A 2023-04-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-11-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-27
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-04-27
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2023-09-15
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-06-12
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-04-26
MAE Occluder, Patent Ductus, Arteriosus Unknown Class 3 N/A 2020-07-29
MLV Transcatheter Septal Occluder Unknown Class 3 N/A 2020-07-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-26
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2019-05-16
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2019-05-16
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-04-26
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2023-04-26
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief Neurology Class 2 882.5890 2024-04-04
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2023-04-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-27
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-04-25
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2023-04-25
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2023-08-02
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2023-04-27
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2023-04-27
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-04-27
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2019-06-04
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2023-04-27
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-07-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-08-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-27
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2023-08-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2025-11-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-04-27
PKG Bone Marrow Processing Device To Support Hematopoietic Reconstitution Hematology Class 2 864.9245 2023-04-04
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2023-08-02
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-08-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-11-24
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2019-11-22
PPN Percutaneous Catheter, Ultrasound Cardiovascular Class 2 870.1250 2017-07-20
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-16
LQC Lithotriptor, Biliary Mechanical Gastroenterology, Urology Class 2 876.4500 2023-07-31
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-16
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2019-05-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-04-27
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2026-05-22
MGZ Valvulotome Cardiovascular Class 2 870.4885 2026-05-29
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2023-08-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-05-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-04-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-11-24
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2023-04-27
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2023-04-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-07-31
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2021-03-16
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-03-16
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2023-08-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-04-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-26
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-04-26
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-04-26
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2023-01-10
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2023-08-02
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2019-05-16
NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown Class 3 N/A 2023-07-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-10-28
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2023-04-04
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2015-05-08
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2021-01-29
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-07
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-08-21
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-08-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-04-26
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2023-04-26
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2023-07-31
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2023-07-31
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-04-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-24
PCU Pancreatic Stent, Covered, Metallic, Removable Gastroenterology, Urology Class 2 876.5015 2024-12-11
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2024-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health AST, LLC Email: becky_aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

Synergy Health AST, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010421104 STERIS TOMOE SINGAPORE PTE LTD Singapore South West, SG
3009882464 Synergy Health AST, LLC Saxonburg, PA, US
3007738736 Synergy Health AST, SRL Alajuela, CR
3017636737 STERIS Corporation de Republica Dominicana, S.R.L. Santo Domingo, DO
2030598 Synergy Health AST, LLC SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010273872. Last updated year: 2026. Please use registration number 3010273872 when referencing this establishment in official correspondence.
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