Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030598

FEI Number

1000518731

Entity Name

Synergy Health AST, LLC

City/State/Country

SAN DIEGO, CA, US

Establishment Address

9020 Activity Rd Ste D, SAN DIEGO, CA 92126, 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

Synereyes7425 (SDB) - SynergEyes A, - SynergEyes M, - SynergEyes KC, - ClearKone, - SynergEyes PS Shockwave7578 (PT,SDB*) - Shockwave C2 Coronary IVL Catheters Shockwave7578 (PT,SDB*) - Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave7578 (CR1) - Intravascular Lithotripsy (IVL) System with the Shockwave C2 Aero Coronary IVL Catheter Shockwave7578 (PT,SDB*) - shockwave intravascular lithotripsy (ivl) system with the shockwave l6 peripheral ivl catheter ReflowMed7417 (SDB) - Wingman 14, 065cm ReflowMed7417 (SDB) - Wingman 14, 135 cm ReflowMed7417 (SDB) - Wingman 14, 150cm Tenex7426 (SDB) - TX2 MicroTip Synovis6299 (SDB) - Veritas Collagen Matrix Baxter (SDB) - Veritas Collagen Matrix PhillipsImage (PT,SDB) - 518-065 QUICK-CROSS SUPPORT CATHETER, 14 150CM, 5 PACK PhillipsImage (PT,SDB) - 518-066 QUICK-CROSS SUPPORT CATHETER, 35 65CM, 5 PACK Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System CAREFUSION (SDB) - MaxPlus Needleless Connector Nellcor9073 (SDB) - Covidien LLC Allosource1516 (SDB) - VersaWrap BD3803 (SDB) - Powerloc Max BD3803 (SDB) - SafeStep CAREFUSION (SDB) - MaxGuard Multidose Vial Adapter Tenex7426 (SDB) - TXB MicroTip Allosource1516 (SDB) - VersaWrap; Versawrap Tendon Protector CAREFUSION (SDB) - set, administration, intravascular Biomerics6631 (SDB) - Arterial Cannula (EndoReturn) Allosource1516 (SDB) - VersaWrap; Versawrap Tendon Protector Allosource1516 (SDB) - AceConnex Pre-Sutured Fascia Shockwave7578 (PT,SDB) - Shockwave S4 Peripheral Intravascular Lithotripsy (IVL) Catheters Shockwave7578 (PT, SDB) - Lithoplasty Peripheral Balloon Dilatation Catheter BD3803 (SDB) - Magic3 Go, HydroSil Go Allosource1516 (SDB) - HERO DBM Plus Putty Allosource1516 (SDB) - HERO DBM Plus Paste Allosource1516 (SDB) - XEMPLIFI Plus Paste Allosource1516 (SDB) - NuVasive Propel DBM Gel Plus Allosource1516 (SDB) - AlloFuse Plus Paste Allosource1516 (SDB) - BIO DBM Plus Putty w Cancellous Allosource1516 (SDB) - Puros DBM RPM Paste, Cancellous Allosource1516 (SDB) - XEMPLIFI Plus Putty Allosource1516 (SDB) - Puros DBM RPM Putty with Chips Allosource1516 (SDB) - NuVasive Propel DBM Putty Plus Allosource1516 (SDB) - AlloFuse Plus Putty Allosource1516 (SDB) - StimuBlast CB Paste Allosource1516 (SDB) - Stryker DBM Plus Putty (with cancellous) Allosource1516 (SDB) - BIO DBM Plus Paste w Cancellous Allosource1516 (SDB) - BiomaX Bone Graft Putty Allosource1516 (SDB) - StimuBlast CB Putty Allosource1516 (SDB) - Stryker DBM Plus Paste (with cancellous) Allosource1516 (SDB) - ReConnex Pre-Sutured Tendon Allosource1516 (SDB) - VersaWrap; Versawrap Nerve Protector Allosource1516 (SDB) - VersaWrap; Versawrap Nerve Protector Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon Allosource1516 (SDB) - XEMPLIFI Plus Putty Allosource1516 (SDB) - Stryker DBM Plus Putty (with cancellous) Allosource1516 (SDB) - HERO DBM Plus Putty Allosource1516 (SDB) - HERO DBM Plus Paste Allosource1516 (SDB) - Puros DBM RPM Putty with Chips Allosource1516 (SDB) - NuVasive Propel DBM Gel Plus Allosource1516 (SDB) - NuVasive Propel DBM Putty Plus Allosource (SDB) - Puros DBM RPM Paste, Cancellous Allosource1516 (SDB) - AlloFuse Plus Paste Allosource1516 (SDB) - BIO DBM Plus Putty w Cancellous Allosource1516 (SDB) - AlloFuse Plus Putty Allosource1516 (SDB) - BIO DBM Plus Paste w Cancellous Allosource1516 (SDB) - Stryker DBM Plus Paste (with cancellous) Allosource1516 (SDB) - XEMPLIFI Plus Paste Allosource1516 (SDB) - StimuBlast Putty Allosource1516 (SDB) - StimuBlast CB Paste Allosource1516 (SDB) - BiomaX Bone Graft Putty Plus Chips Toby7429 (PT) - PASSER, RETRACTOR Biomerics6631 (SDB) - Disposable Tissue Retractor CAREFUSION (SDB) - MaxGuard/ Max Plus IV Administration Sets CAREFUSION (SDB) - MaxPlus, MaxGuard pressure rated T-connector extension set with needleless connector CAREFUSION (SDB) - MaxPlus pressure rated extension set with needleless connector CAREFUSION (SDB) - MaxPlus pressure rated extension set with removable needleless connector CAREFUSION (SDB) - Medegen Pressure Rated Extension Sets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-11-14
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2023-11-14
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2012-11-16
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-02-25
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-09-19
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2024-01-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-01-05
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-10-07
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2023-06-02
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2012-12-11
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2012-12-11
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2012-12-11
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2012-12-11
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-13
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2017-07-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-10-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-01-29
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2023-11-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-06
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-08-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2022-11-02
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-10-28
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-11-16
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
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-12-31
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-10-07
NQR	Sealant, Dural	Unknown	Class 3	N/A	2012-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-07
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2023-01-19
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2013-01-10
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-01-10
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2019-01-10
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-07
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-06-12
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2012-11-16
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2015-10-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2020-12-17
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-12-05
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-14
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-01-05
NQR	Sealant, Dural	Unknown	Class 3	N/A	2012-11-15
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2017-07-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2015-10-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-25
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-25
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-01-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-02-23
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
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
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-04-10
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Unknown	Class 3	N/A	2024-08-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-11-14
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2017-07-26
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2020-12-17
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2023-12-13
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown	Class 3	N/A	2012-12-13
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2012-12-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-11-19
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2023-11-30
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2012-11-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-11-16
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2015-10-28
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2024-02-14
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-25
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2017-08-04
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown	Class 3	N/A	2017-08-04
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-12-31
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-07-31
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-11-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-04-15
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2014-07-23

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
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
3012102437	Synergy Health AST, LLC	Petaluma, CA, US

Related 510(k) Records

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K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030598. Last updated year: 2026. Please use registration number 2030598 when referencing this establishment in official correspondence.