BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Synergy Health AST, LLC

    Reg #: 3009882464 · FEI: 3009882464 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    90
    Establishment Types
    2
    Classifications
    37

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    3009882464
    FEI Number
    3009882464
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7225 N Noah Dr
    City
    Saxonburg
    State
    PA
    ZIP
    16056
    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
    Set, Administration, Intravascular FPA
    Wound Dressing With Animal-Derived Material(S) KGN
    Mesh, Surgical FTM
    Injector, Contrast Medium, Automatic IZQ
    Injector And Syringe, Angiographic DXT
    System, Imaging, Optical Coherence Tomography (Oct) NQQ
    Optical Coherence Tomography, Intravascular Catheter ORD
    Mesh, Surgical, Collagen, Large Abdominal Wall Defects OXK
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
    Filler, Bone Void, Calcium Compound MQV
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Implant, Dermal, For Aesthetic Use LMH
    Apparatus, Exhaust, Surgical FYD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Suction, Lipoplasty MUU
    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
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Needle, Acupuncture, Single Use MQX
    Dressing, Wound, Hydrophilic NAC
    Catheter For Crossing Total Occlusions PDU
    Sensor, Glucose, Invasive MDS
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Sealant, Dural NQR
    Dressing, Wound, Occlusive NAD
    Pipette, Diluting GGY
    Dressing, Wound And Burn, Interactive MGR
    Device, Dermal Replacement MDD
    Tubing, Noninvasive GAZ
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Automated Insulin Dosing Device System, Single Hormonal Control OZP
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Intracardiac Patch Or Pledget, Biologically Derived PSQ

    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) - FUMOVAC Conmed (SX) - OR-VAC Conmed (SX) - TUBING, NONINVASIVE Conmed (SX) - HARMONYAIR Conmed (SX) - VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM Bayer1675 (SX) - CT TRI-PAK Sterile Disposable Syringe Integra2419 (SX)) - Integra Meshed Bilayer Wound Matrix Bayer1673 (SX) - 150 mL Sterile Disposable Syringes with Quick Fill Tubes Bayer1675 (SX) - 150 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1673 (SX) - 200 mL Sterile Disposable Syringes with Small Contrast Spikes Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringes with Spikes Bayer1673 (SX) - 150 mL Sterile Disposable Syringes with Spikes Bayer1675 (SX) - MEDRAD Stellant FLEX 200 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1675 (SX) - MEDRAD Stellant Single Syringe with QFT Bayer1675 (SX) - MEDRAD Stellant Single Syringe Tri-Pak with Spike Bayer1675 (SX) - 200 mL Sterile Disposable Syringe with Spike Bayer1675 (SX) - MEDRAD Stellant FLEX 200mL Sterile Disposable Syringes with Spikes Bayer1673 (SX) - 200 mL Sterile Disposable Syringes with Spikes Bayer1673 (SX) - 200 mL Sterile Disposable Syringes with Quick Fill Tubes Bayer1673 (SX) - 200 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1673 (SX) - MEDRAD Stellant FLEX 200 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1675 (SX) - MEDRAD Stellant FLEX 200mL Sterile Disposable Syringes with Quick Fill Tubes Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike Bayer1673 (SX) - 150 mL Sterile Disposable Syringes with Small Contrast Spikes Bayer1673 (SX) MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringe with Spike Bayer1675 (SX) - MEDRAD Stellant FLEX 200mL Sterile Disposable Syringes with Small Contrast Spikes Bayer1675 (SX) - 150 mL Sterile Disposable Syringe with Spike Bayer1675 (SX) - MEDRAD Stellant FLEX 200 mL Sterile Disposable Syringe with Spike Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringes with Small Contrast Spikes Bayer1673 (SX) - MEDRAD Stellant FLEX 150 mL Sterile Disposable Syringes with Quick Fill Tubes Bayer1675 (SX) - MEDRAD Stellant Single Syringe Tri-Pak with QFT Bayer1673 (SX) - MEDRAD Stellant Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike Bayer1675 (SX) - MEDRAD Stellant Single Syringe with Spike Conmed (SX) - SHE SHA Conmed (SX) - APPARATUS, EXHAUST, SURGICAL Bayer1673 (SX) - CT TRI-PAK Sterile Disposable Syringe Bayer1673 (SX) - CT TRI-PAK 200mL Sterile Disposable Syringe

    Establishment Types

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