FDA Registration
Active
🇮🇪 Ireland
Synergy Health Westport Ltd
Reg #: 3010173425
·
FEI: 3002807036
·
Expires 2026
Products
100
Proprietary Names
60
Establishment Types
1
Classifications
100
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Registration Details
- Registration Name
- Synergy Health Westport Ltd
- Registration Number
- 3010173425
- FEI Number
- 3002807036
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lodge Road
- City
- Westport Mayo
- Country
- IE
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2016-04-26 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-02-13 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2019-02-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-02-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-02-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-09-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-02-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2015-12-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-02-21 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2015-12-07 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Filter, Conduction, Anesthetic | BSN | Class 2 | Anesthesiology | No | 2013-02-12 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2020-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-02-13 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2019-12-30 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2024-05-09 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2023-12-19 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2017-03-23 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2013-02-18 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2018-01-19 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2021-07-15 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2021-07-15 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-02-26 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2017-03-23 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2017-03-23 |
| Fixation Accessory | LYT | Class 2 | Orthopedic | No | 2013-02-26 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-02-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2015-08-25 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | LGE | Class 2 | Orthopedic | No | 2013-02-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-15 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2013-02-27 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2016-02-17 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2016-02-17 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-02-14 |
| Electrode, Needle, Diagnostic Electromyograph | IKT | Class 2 | Physical Medicine | No | 2013-02-28 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-02-15 |
| Hydrogel Spacer | OVB | Class 2 | Radiology | No | 2025-05-12 |
| Blade, Saw, Surgical, Cardiovascular | DWH | Class 1 | General, Plastic Surgery | No | 2013-12-24 |
| Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | QFC | Class 2 | General, Plastic Surgery | No | 2026-01-30 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2017-02-27 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-12-24 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2013-01-30 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2025-09-24 |
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2012-12-20 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | NJL | Class 3 | Unknown | No | 2013-12-24 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2013-01-30 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2013-12-24 |
| Negative Pressure Wound Therapy Non-Powered Suction Apparatus | OKO | Class 2 | General, Plastic Surgery | No | 2020-04-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-11-18 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2013-03-13 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2016-11-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2016-11-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-15 |
| Methyl Methacrylate For Cranioplasty | GXP | Class 2 | Neurology | No | 2013-02-14 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2013-02-28 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-09-10 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-09-10 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-09-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-03-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | MRA | Class 3 | Unknown | No | 2013-02-27 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2013-02-15 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2013-02-26 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-12-18 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2015-12-07 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2017-01-16 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2024-10-14 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2020-03-10 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2017-07-31 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2013-02-27 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2014-12-29 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2014-12-29 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2014-12-29 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2023-12-19 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2014-01-02 |
| Stent, Metallic, Expandable, Duodenal | MUM | Class 2 | General, Plastic Surgery | No | 2014-01-02 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2014-01-02 |
| Stent, Colonic, Metallic, Expandable | MQR | Class 2 | General, Plastic Surgery | No | 2014-01-02 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2014-01-02 |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | Class 2 | General, Plastic Surgery | No | 2024-02-19 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2016-02-17 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2016-02-17 |
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2022-08-22 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-02-14 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-02-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-04-28 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-09-25 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2013-02-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-12-13 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2014-07-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
Proprietary Names
Zimmer (WP) - ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
StrykerIreland (WP) - Tritanium PL Cages
Molnlycke (KK,VL) - Lyofoam Max
FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive
Molnlycke (KK,VL) - Lyofoam Dressings
FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive
FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive
FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive
AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing
FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive
FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive
Zimmer (WP) - ZIMMER M/L TAPER HIP PROSTHESIS
DePuyIreland (RG,WP) - Corail
Hollister (WP) - VaPro Plus
Hollister (WP) - VaPro
Zimmer (WP,DK) - NexGen Cruciate Retaining
Zimmer (WP) - ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
DePuyIreland (RG,WP) - Pinnacle
Zimmer (WP) - NG COMPLETE KNEE SOLUTION CRA-CCK BASE NO. 5984
Zimmer (WP) - PERSONA Natural Tibia BASEPLATES
Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN
Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN
Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec
Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins
Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi
Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins;
Zimmer (DK,WP) - Persona Partial Knee System
Zimmer (WP,DK) - NexGen Gender Sol. Female (GSF) Fem
Natus10057 (ED) - TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
Zimmer (WP) - Zimmer M/L Taper Hip Prosthesis
Zimmer (WP) - ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
Hollister (WP) - VaPro Pocket (20cm/8 inch)
Zimmer (WP) - Persona the Personalized Knee System
Zimmer (WP,DK) - NexGen Legacy Posterior Stabilized
Zimmer (WP,DK) - NG COMPLETE KNEE SOLUTION PS-CR BASE NO. 5970, 5971, 5972, 5980, 5982
Newclip11561 (MS) - BIT, DRILL
Zimmer (WP) - NexGen Knee Components
Zimmer (WP) - Comprehensive Shoulder System
Zimmer (DK,WP) - Persona Partial Knee
DePuyIreland (RG,WP) - Delta XTend
Lisi34951 (ED) - Exeter V40, 37.5mm, N1, L. 125mm
Lisi34951 (ED) - Orthinox 22.2mm/-2mm V40 Femoral Head
Lisi34951 (ED) - Orthinox 22.2mm/+3mm V40 Femoral Head
Lisi34951 (ED) - Exeter V40, 37.5mm, N1, L.205 fully tapered
Lisi34951 (ED) - Exeter V40, 56mm,N2, L. 150mm
Lisi34951 (ED) - Exeter V40, 50mm, N1, L. 125mm
Lisi34951 (ED) - Exeter V40, 56mm,N1, L. 150mm
Lisi34951 (ED) - Exeter V40, 44mm, N1, L. 125mm
Lisi34951 (ED) - Exeter Hip System
Puregraft8291 (WP) - Puregraft 850 System
Zimmer (DV,RG,WP) - G7 OSSEOTI ACETUBLAR SHELLS
Harmac2308 (WP) - Puregraft 250 System
Puregraft8291 (WP) - Puregraft 50 System
Zimmer (WP) - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
Biotech10016 (WP) - IC-8 Apthera IOL
Lisi34951 (ED) - Femoral Head
Puregraft8291 (WP) - Puregraft 250 System
Harmac2308 (WP) - Puregraft 850 System
Zimmer (WP) - TRILOGY ACETABULAR SYSTEM
Harmac2308 (WP) - Puregraft 50
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)