Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009882464

FEI Number

3009882464

Entity Name

Synergy Health AST, LLC

City/State/Country

Saxonburg, PA, US

Establishment Address

7225 N Noah Dr, Saxonburg, PA 16056, US

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Integra2419 (SX) - INTEGRA Wound Matrix (Thin) Integra2419 (SX) - TENDON WRAP TENDON PROTECTOR Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Dual Syringe Kits with Spikes Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Single Syringe Kits with Spike Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Dual Syringe Kits with QFT Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Single Syringe Kits with QFT Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Single Syringe Kits with Spike Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Dual Syringe Kits with a Large Saline Spike and a Small Contrast Spike Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Single Syringe Kits with QFT Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Dual Syringe Kits with Spike Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Dual Syringe Kits with a Large Saline Spike and a Small Contrast Spike Gentuity7546 (SX) - HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter Bayer1673 (SX) - Sterile Disposable MRI Kit Conmed (SX) - PENADAPT Bayer1673 (SX) - MEDRAD® Stellant Multi-Patient Kit Bayer1675 (SX) - Disposable MRI Kit with Check Valve Conmed (SX) - PLUMEPORT Bayer1673 (SX) - Disposable MRI Kit for 65/115 MR Injector System Integra2421 (SX) - INTEGRA Flowable Wound Matrix, MODEL FWD301 CRBard4757 (SX) - Crosser 146cm 14S Peripheral Rx CTO Recanalization Catheter w/ GeoAlign CRBard4757 (SX) - Crosser 154cm S6 Peripheral CTO Recanalization Catheter w/ GeoAlign CRBard4757 (SX) - Crosser 106cm S6 Peripheral CTO Recanalization Catheter w/ GeoAlign CRBard4757 (SX) - Crosser 106cm 14S Peripheral OTW CTO Recanalization Catheter w/ Geo. CRBard4757 (SX) - Crosser 146cm 14S Peripheral OTW CTO Recanalization Catheter w/ Geo. CRBard4757 (SX) - Crosser 106cm 14S Peripheral RX CTO Recanalization Catheter w/ GeoAlign Integra2419 (SX) - "AVAGEN WOUND DRESSING " Bayer1673 (SX) -ProVis 150 mL FasTurn Sterile Disposable Syringe (150-FT) Integra2419 (SX) - Bilayer Matrix Wound Dressing Bayer1673 (SX) - KIT, 65/115 ML FLS / 2 Spikes 96 LPDCT / Integral T/CV, MRI SSQK 65/115VS Bayer1673 (SX) - MEDRAD 150mL FasTurn Sterile Disposable Syringe with QFT Bayer1673 (SX) - MEDRAD 200mL FasTurn Sterile Disposable Syringe with QFT Bayer1673 (SX) - MEDRAD 200mL FasTurn Sterile Disposable Syringe Bayer1673 (SX) - MEDRAD 150mL FasTurn Sterile Disposable Syringe Bayer1673 (SX) -ProVis 200 mL FasTurn Sterile Disposable Syringe (200-FT) Bayer1673 (SX) - 200 mL FasTurn Sterile Disposable Syringe & QFT Bayer1673 (SX) - Sterile Disposable Syringe 150 mL & QFT Bayer1675 (SX) - MEDRAD Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT Bayer1675 (SX) -MEDRAD Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT Bayer1673 (SX) - Stellant Single Syringe Kit with SPK Bayer1673 (SX) - Stellant Dual Syringe Quad-Pak with Spikes Bayer1673 (SX) - Stellant Dual Quad-Pak with QFT Bayer1673 (SX) - Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike Bayer1673 (SX) - Stellant Single Syringe Tri-Pak Kit with QFT Bayer1673 (SX) - Stellant Single Syringe Tri-Pak Kit with SPK Bayer1673 (SX) - Stellant Single Syringe Kit with QFT Bayer1673 (SX) - Dual Syringe Quad-Pak with Spikes Bayer1673 (SX) - Single Syringe with Spike Bayer1673 (SX) - Single Syringe Tri-Pak with Spike Bayer1673 (SX) - Dual Syringe Quad-Pak with QFT Bayer1673 (SX) - Single Syringe with QFT Bayer1673 (SX) - Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike Bayer1673 (SX) - Single Syringe Tri-Pak with QFT Conmed (SX) - PLUMEPORT Conmed (SX) - FUMOVAC Conmed (SX) - OR-VAC Conmed (SX) - TUBING, NONINVASIVE Conmed (SX) - HARMONYAIR Conmed (SX) - VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-06-11
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-09-24
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-08-30
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-10-22
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2018-10-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2018-10-19
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2020-05-29
ORD	Optical Coherence Tomography, Intravascular Catheter	Cardiovascular	Class 2	870.1200	2020-05-29
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2015-12-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	General, Plastic Surgery	Class 2	878.3300	2019-06-13
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-07-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-06-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-21
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
LMH	Implant, Dermal, For Aesthetic Use	Unknown	Class 3	N/A	2018-10-24
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2024-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-11-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2026-03-12
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-10-31
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2024-11-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-07-21
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2018-12-05
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2015-12-05
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-11-07
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2012-12-26
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2012-12-26
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2012-12-26
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2012-12-26
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2012-12-26
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2012-12-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2018-09-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-06-17
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2016-08-31
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2020-12-18
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2020-12-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2012-11-15
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2020-02-28
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-06-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-11-07
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-10-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-07-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-08-30
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2024-09-19
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2024-09-19
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-07-21
NQR	Sealant, Dural	Unknown	Class 3	N/A	2023-08-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-11-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-06-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-06-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-06-13
GGY	Pipette, Diluting	Hematology	Class 1	864.6160	2012-11-15
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2019-06-13
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-06-13
MGR	Dressing, Wound And Burn, Interactive	Unknown	Class 3	N/A	2015-12-30
MDD	Device, Dermal Replacement	Unknown	Class 3	N/A	2015-12-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
NQR	Sealant, Dural	Unknown	Class 3	N/A	2023-08-17
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2013-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
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
3012102437	Synergy Health AST, LLC	Petaluma, CA, US

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009882464. Last updated year: 2026. Please use registration number 3009882464 when referencing this establishment in official correspondence.