BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Synergy Health AST, LLC

    Reg #: 3012102437 · FEI: 3012102437 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    39
    Establishment Types
    2
    Classifications
    31

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    3012102437
    FEI Number
    3012102437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3200 Lakeville Hwy, Suite 120
    City
    Petaluma
    State
    CA
    ZIP
    94954
    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
    Wound Dressing With Animal-Derived Material(S) KGN
    Filler, Bone Void, Calcium Compound MQV
    Catheter, Percutaneous DQY
    Percutaneous Catheter, Ultrasound PPN
    Curette, Nasal KAP
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Mesh, Surgical FTM
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Separator, Automated, Blood Cell, Diagnostic GKT
    Aspiration Thrombectomy Catheter QEZ
    Stimulator, Nerve ETN
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Passer HWQ
    Shockwave Intravascular Lithotripsy System QMG
    Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO
    Sealant, Dural NQR
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Sensor, Glucose, Invasive MDS
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Device, Irrigation, Ocular Surgery KYG
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB
    Drug-Eluting Sinus Stent OWO
    Sealant, Polymerizing NBE
    System, Suction, Lipoplasty MUU
    Device, Hemostasis, Vascular MGB
    Syringe, Piston FMF
    Retractor GAD

    Proprietary Names

    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 Shockwave7578 (CR1,PT) - Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter Arlington8227 (SDB) - Curette, Nasal Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System LSO2556 (PT) - Osteo-P Bone Graph Substitue Shockwave7578 (PT,SDB) - Shockwave S4 Peripheral Intravascular Lithotripsy (IVL) Catheters Terumo2207 (PT) - Rika Plasma Bottle Shockwave7578 (PT,SDB*) - shockwave intravascular lithotripsy (ivl) system with the shockwave l6 peripheral ivl catheter PhillipsImage (PT,SDB) - 60090-01 QUICKCAT EXTRACTION CATHETER Arthocare8208 (CR1) - CAP-FIXCAP-FIX SUTURE PASSER 70 DEG Arthocare8208 (CR1) - CAP-FIX SUTURE PASSER 45 DEG Arthocare8208 (CR2) - ACCU-PASS DIRECT Suture Passer, Crescent XL Toby7429 (PT) - PASSER, RETRACTOR 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 Xvivo7433 (PT) - STEEN Solution Xvivo7433 (PT) - XVIVO Disposable Lung Circuit Xvivo7433 (PT) - XVIVO Disposable Kit Xvivo7433 (PT) - XVIVO Lung Cannula Set Xvivo7433 (PT) - XVIVO Organ Chamber Xvivo7433 (PT) - XPS Xvivo7433 (PT) - XVIVO PGM Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon Shockwave7578 (PT,SDB) - Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave7578 (PT, SDB) - Lithoplasty Peripheral Balloon Dilatation Catheter Mortan11220 (PT) - Device, Irrigation, Ocular Surgery StimLab7532 (PT) - Allacor P StimLab7532 (PT) - Corplex P Intersect7571 (PT,SDB) - Drug-eluting sinus stent 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 Biomerics6631 (SDB) - Disposable Tissue Retractor

    Establishment Types

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