BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Synergy Health AST, LLC

    Reg #: 2030598 · FEI: 1000518731 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    76
    Establishment Types
    2
    Classifications
    51

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    2030598
    FEI Number
    1000518731
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9020 Activity Rd Ste D
    City
    SAN DIEGO
    State
    CA
    ZIP
    92126
    Country
    US

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    System, Planning, Radiation Therapy Treatment MUJ
    Mesh, Surgical FTM
    Lens, Contact (Other Material) - Daily HQD
    Shockwave Intravascular Lithotripsy System QMG
    Percutaneous Catheter, Ultrasound PPN
    Catheter For Crossing Total Occlusions PDU
    Catheter, Percutaneous DQY
    Instrument, Ultrasonic Surgical LFL
    Agent, Absorbable Hemostatic, Non-Collagen Based LMG
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction OXB
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Device, Neurovascular Embolization HCG
    Sealant, Polymerizing NBE
    Wound Dressing With Animal-Derived Material(S) KGN
    Syringe, Piston FMF
    Device, Vascular, For Promoting Embolization KRD
    Catheter, Hemodialysis, Implanted MSD
    Set, Administration, Intravascular FPA
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Sealant, Dural NQR
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    System/Device, Pharmacy Compounding NEP
    Set, I.V. Fluid Transfer LHI
    Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon OWW
    Alternate Controller Enabled Insulin Infusion Pump QFG
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Stimulator, Nerve ETN
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Filler, Bone Void, Calcium Compound MQV
    Catheter, Straight EZD
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Laparoscope, Gynecologic (And Accessories) HET
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cuff, Nerve JXI
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor OYC
    Sensor, Glucose, Invasive MDS
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Retractor GAD
    Cable, Electrode IKD
    Drug-Eluting Sinus Stent OWO
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Culture Media, Non-Selective And Non-Differential JSG
    Introducer, Catheter DYB
    Instruments, Surgical, Cardiovascular DWS
    Aspiration Thrombectomy Catheter QEZ

    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) - 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 Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon Allosource (SDB) - Puros DBM RPM Paste, Cancellous Allosource1516 (SDB) - StimuBlast Putty 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 Intersect7571 (PT,SDB) - Drug-eluting sinus stent LifeSci7643 (SDB) - Plateav-C Hardy7378 (SDB) - MycoVue PFA Tenex7426 (SDB) - TX1 MicroTip BD3803 (SDB) - Liftloc EdwardsLife6723 (SDB) - Thruport Introducer Sheath Biomerics6631 (SDB) - Arterial Cannula Biomerics6631 (SDB) - Disposable Knot Pusher EdwardsLife6723 (SDB) - KONECT RESILIA Aortic Valved Conduit Spectranetics3268 (PT,SDB) - 518-033 QUICK-CROSS SUPPORT CATHETER, 18, 90CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-036 QUICK-CROSS SUPPORT CATHETER, 35, 90CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-037 QUICK-CROSS SUPPORT CATHETER, 35, 135CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-034 QUICK-CROSS SUPPORT CATHETER, 18, 135CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-038 QUICK-CROSS SUPPORT CATHETER, 35, 150CM, 5 PACK PhillipsImage (PT,SDB) - 518-032 QUICK-CROSS SUPPORT CATHETER, 14, 135CM, 5 PACK PhillipsImage (PT,SDB) - 518-035 QUICK-CROSS SUPPORT CATHETER, 18, 150CM, 5 PACK PhillipsImage (PT,SDB) - 60090-01 QUICKCAT EXTRACTION CATHETER Shockwave7578 (PT,SDB) - Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Device in the United States for Export Only