BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Synergy Health AST, SRL

    Reg #: 3007738736 · FEI: 3007738736 · Expires 2026
    View on FDA
    Products
    49
    Proprietary Names
    102
    Establishment Types
    1
    Classifications
    49

    Registration Details

    Registration Name
    Synergy Health AST, SRL
    Registration Number
    3007738736
    FEI Number
    3007738736
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B16 Street 4, Avenue 0, Coyol Free Zone
    City
    Alajuela
    Country
    CR

    Owner / Operator

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

    US Agent

    Business Name
    Synergy Health AST, LLC
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Rd
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 4687462

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Wire, Guide, Catheter DQX
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    Device, Vascular, For Promoting Embolization KRD
    Media, Reproductive MQL
    Labware, Assisted Reproduction MQK
    Marker, Radiographic, Implantable NEU
    Instrument, Biopsy KNW
    Infusion Safety Management Software PHC
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    Device, Neurovascular Embolization HCG
    Expander, Surgical, Skin Graft FZW
    Passer, Wire, Orthopedic HXI
    Aid, Transfer IKX
    Electrode, Circular (Spiral), Scalp And Applicator HGP
    Snare, Flexible FDI
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Urethral GBM
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Tube, Aspirating, Flexible, Connecting BYY
    Shockwave Intravascular Lithotripsy System QMG
    Percutaneous Catheter, Ultrasound PPN
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA
    Catheter, Percutaneous DQY
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Accessories, Pump, Infusion MRZ
    Passer HWQ
    Forceps, Biopsy, Electric KGE
    Instrument, Ent Manual Surgical LRC
    Temporary Carotid Catheter For Embolic Capture NTE
    Intracranial Coil-Assist Stent QCA
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Powder, Porcelain EIH
    Forceps, Biopsy, Non-Electric FCL
    Echocardiograph DXK
    Stopcock, I.V. Set FMG
    Wound Dressing With Animal-Derived Material(S) KGN
    Pump, Infusion, Pca MEA
    Forceps, Biopsy, Bronchoscope (Non-Rigid) BWH
    Accessories, Arthroscopic NBH
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Bronchoscope (Flexible Or Rigid) EOQ
    Arthroscope HRX
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Catheter, Irrigation GBX

    Proprietary Names

    Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - TURBINATOR Wand (MULS) Arthocare8208 (CR1) - EXCISE PDW Wand with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE XP Wand with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA SP with Integrated Cable Arthocare8208 (CR1) - TURBINATOR Wand Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable Arthocare8208 (CR1) - PROCISE MLW Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - REFLEX ULTRA 45 with Integrated Cable Arthocare8208 (CR1) - PROCISE LW Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable Arthocare8208 (CR1) - REFLEX ULTRA PTR with Integrated Cable (MULS) Arthocare8208 (CR1) - EVAC 70 HP with Integrated Cable (MULS) Arthocare8208 (CR1) - EVAC 70 Xtra with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ Wand with Integrated Cable (MULS) Arthocare8208 (CR1) - REFLEX ULTRA 55 with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE MAX with Integrated Cable (MULS) Arthocare8208 (CR1) - PROCISE EZ-View with Integrated Cable (MULS) AbbottVasc (CR1) - HT Whisper LS AbbottVasc (CR1) - HT Whisper ES Establishment9150 (CR1) - Motiva Inflatable Balloon AbbottVasc (CR1) - HT WINN AbbottVasc (CR1) - HT Balance Colplast1941 (CR1) - SpeediCath Flex Coude Pro AbbottVasc (CR1) - HT Command 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 (CR1,PT) - Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter Colplast1941 (CR1) - SpeediCath Standard AbbottVasc (CR1) - ARMADA 35 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 Acclarent8881 (CR2) - RELIEVA ULTIRRA NAV Sinus Balloon Catheter Arthocare8208 (CR1) - Topaz EZ IFS Acclarent8881 (CR2) - TruDi Curette AbbottVasc (CR1) - HT Balance Middleweight Arthocare8208 (CR1) - AMBIENT HIPVAC 50 IFS Arthocare8208 (CR1) - Super MULTIVAC 50 IFS 3.75mm 50 Suction Arthocare8208 (CR1) - AMBIENT Super MULTIVAC 50 3.75mm 50 Suction IFS Arthocare8208 (CR2) - FAST-FIX 360 STRAIGHT KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS Arthocare8208 (CR2) - FIRSTPASS ST Suture Passer Self-Capture Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Straight Arthocare8208 (CR2) - FIRSTPASS ST Suture Passer Standar Arthocare8208 (CR2) - ULTRA FAST-FIX KNOT PUSHER/SUTURE CUTTER STRAIGHT Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 8.5X90 Arthocare8208 (CR2) - FAST-FIX 360 CURVED KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS Arthocare8208 (CR1) - FIRSTPASS Needle and Suture Capture Arthocare8208 (CR2) - FIRSTPASS Mini Suture Passer, Left Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 7X110 Arthocare8208 (CR1) - CAP-FIX Blade, Straight, with Handle Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 7X90 Arthocare8208 (CR2) - CLEAR TRAC COMPLETE HIP CANNULA 8.5X110 AbbottVasc (CR1) - HT Balance Heavyweight ICU7944 (CR1) - IV Administration AbbottVasc (CR1) - HT Balance Universal BSCI (CR1) -Escape Nitinol Stone Retrieval Basket Gemini Paired Wire Helical Stone Retrieval Basket Graspit Nitinol Ston Arthocare8208 (CR1) - PARAGON T2 2.3mm 15 Acclarent8881 (CR2) - RELIEVA SCOUT Multi-Sinus Dilation System AbbottVasc (CR1) - HT Pilot AbbottVasc (CR1) - HT Progress Microvention7401 (CR1) - Azur Peripheral Coil - Detachable 35 Framing Arthocare8208 (CR1) - Right Angle 90 3.5mm 90 ICW Arthocare8208 (CR1) - MULTIVAC 50 XL 3.75mm 50 Suction Arthocare8208 (CR1) - LOPRO 90 3.6mm 90 ICW Arthocare8208 (CR1) -COVAC 70 Arthocare8208 (CR1) - Short Bevel 35 2.3mm 35 ICW Arthocare8208 (CR1) -COVAC 50 Arthocare8208 (CR1) - TURBOVAC 90 XL Arthocare8208 (CR1) - Bevel 45 3mm 45 ICW Arthocare8208 (CR1) - MICROBLATOR 30 1.4mm 30 Arthocare8208 (CR1) - Super MULTIVAC 50 3.75mm 50 Suction Arthocare8208 (CR1) - ELIMINATOR 90 4.5mm 90 ICW Arthocare8208 (CR1) - Dome 60 2.5mm 60 Arthocare8208 (CR1) - CAPSURE 30 3mm 30 Arthocare8208 (CR1) -TRISTAR 50 3mm 50 Suction ICW Arthocare8208 (CR1) - MENIVAC 45 3mm 45 Suction Arthocare8208 (CR1) - SABER 30 3mm 30 ICW Arthocare8208 (CR1) - Super TURBOVAC 90 3.75mm 90 Suction Arthocare8208 (CR1) - STARVAC 90 3.75mm 90 Suction Arthocare8208 (CR1) - SIDEWINDER Blade 2.7mm Arthocare8208 (CR1) - AMBIENT Super TURBOVAC 90 3.75mm 90 Suction IFS Arthocare8208 (CR1) - TOPAZ XL IFS 1.27mm 15 Arthocare8208 (CR1) - Super TURBOVAC 90 IFS 3.75mm 90 Suction Arthocare8208 (CR1) - AMBIENT COVAC 70 IFS 3mm 70 Suction Arthocare8208 (CR1) - COVATOR 20 3.3mm 20 Arthocare8208 (CR1) - AMBIENT MEGAVAC 90 4.2mm 90 Suction Arthocare8208 (CR1) - TOPAZ EZ MicroDebrider IFS 16mm Arthocare8208 (CR1) - TOPAZ XL 1.27mm 15 Arthocare8208 (CR1) - AMBIENT COVAC 50 IFS 3mm 50 Suction

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)