FDA Registration
Active
🇫🇷 France
Synergy Health Marseille SAS
Reg #: 3010162973
·
FEI: 3002807041
·
Expires 2026
Products
64
Proprietary Names
84
Establishment Types
1
Classifications
64
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Registration Details
- Registration Name
- Synergy Health Marseille SAS
- Registration Number
- 3010162973
- FEI Number
- 3002807041
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MIN 712 - LES Arnavaux
- City
- MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur
- Country
- FR
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 |
|---|---|---|---|---|---|
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2020-01-02 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-03-07 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2019-02-20 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2017-01-09 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-11-03 |
| Prosthesis, Ankle, Uncemented, Non-Constrained | NTG | Class 3 | Unknown | No | 2023-05-23 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-01-19 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2025-02-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-15 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-11-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-12-19 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-11-17 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2025-11-24 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2019-03-04 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-03-07 |
| Graft, Vascular, Synthetic/Biologic Composite | MAL | Class 2 | Cardiovascular | No | 2019-03-04 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2024-05-22 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-11-21 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-11-21 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-11-21 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-03-07 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-01-19 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-01-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-01-19 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-01-19 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2023-05-23 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2013-01-08 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2024-02-29 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-11-26 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2024-05-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-02-23 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2025-06-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-11-13 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-04-28 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2025-11-24 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2019-11-11 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-15 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2020-01-06 |
| Crutch, Ptosis | HJZ | Class 1 | Ophthalmic | No | 2025-11-24 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2015-11-03 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2018-06-18 |
| Prosthesis, Finger, Semi-Constrained, Metal/Polymer | SFA | Class 3 | Unknown | No | 2026-05-28 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-03-07 |
| Absorbable Collagen Hemostatic Agent With Thrombin | PMX | Class 3 | General, Plastic Surgery | No | 2026-05-28 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2025-11-24 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2026-04-07 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-12-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2016-11-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-02-17 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2015-08-06 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2025-02-26 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2013-02-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-02-05 |
| Implant, Orbital, Extra-Ocular | HQX | Class 2 | Ophthalmic | No | 2025-11-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2019-03-07 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2024-02-29 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2025-02-26 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2016-11-12 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2025-11-24 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2025-02-26 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2025-11-21 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2017-01-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-15 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2019-03-04 |
Proprietary Names
DTMedtech10904 (MS) - Hintermann Series H3 Total Ankle Replacement System
BBraun11480 (MS) - B. Braun Surgical, S.A. (Dagrofil)
Newclip11561 (MS) -Clavicle Plate screwdriver; Clavicle prehensor screwdriver countersink; Distal Radius Plate screwdriv
Newclip11561 (MS) - ACTIV Ankle RemovalkitACTIV Ankle screwdriver; Alians Fragment Specific screwdriver; Alians screwdri
Newclip11561 (MS) - Distal Radius removal kit; Elbow screwdriver; Foot & Hand Motion screwdriver; Footmotion screwdrive
Newclip11561 (MS) - HTO hexagonal screwdriver; Large screw screwdriver; Newclip Radius screwdriver; Newclip Shoulder
FCI11517 (MS) - Enucleation/evisceration implants
Newclip11561 (MS) - Distal Radius Plating System
Newclip11561 (MS) - Large Screw System
Newclip11561 (MS) - FTP
DTMedtech10904 (MS) - Hintermann Series H2 Total Ankle System
Newclip11561 (MS) - Humerus Locking Plating System
Newclip11561 (MS) - Footmotion Plating System
Newclip11561 (MS) - Radius instrumentation set; Ulnar Instrumentation set
Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti
DORC10527 (VL1) - Tray, Surgical, Instrument
Newclip11561 (MS) - Stainless steel - Cover; HammerToe instrumentation set - Base; HammerToe instrumentation set
Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion
Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe
Newclip11561 (MS) - Screws tray; Activ instrumentation set Top Alians Elbow Distal Humerus Y Plates instrumentation set
Newclip11561 (MS) - HammerToe instrumentation set Stainless steel - Base; Humerus instrumentation set; Large screw
Newclip11561 (MS) - Length gauge for pin L120 mm / template for extremity screws - STERILE
Newclip11561 (MS) - Length gauge for pin 1.2 mm - L75 mm - STERILE
Newclip11561 (MS) - Activ Fuse
FCI11517 (MS) - Ocular Shield
FCI11517 (MS) - SILICONE CONFORMER
FCI11517 (MS) - SYMBLEPHARON RINGS, 25MM LARGE
FCI11517 (MS) - PERFORATED CONFORMERS, 26MM LARGE
FCI11517 (MS) - SYMBLEPHARON RINGS, 20MM SMALL
FCI11517 (MS) - PERFORATED CONFORMERS, 23MM MEDIUM
FCI11517 (MS) - SYMBLEPHARON RINGS, 22MM MEDIUM
FCI11517 (MS) - PERFORATED CONFORMERS, 20MM SMALL
Noraker11562 (MS) - GlassBone Granules
FCI11517 (MS) - LACRIMAL DILATOR DISPOSABLE
Newclip11561 (MS) - BIT, DRILL
Newclip11561 (MS) - Alians Fragment Specific
FCI11517 (MS) - Ptosis Sling
Noraker11562 (MS) - ARTHREX QUICKSET; ARTHREX QUICKSET KIT; GRAFTYS QUICKSET; GRAFTYS QUICKSET KIT
Newclip11561 (MS) - Alians Elbow Plating System
Newclip11561 (MS) - KEMIS H,3 Knife
Newclip11561 (MS) - DTO S
Newclip11561 (MS) - Activmotion S
Keri12785 (MS) - TOUCH CMC 1 Prosthesis
Teknimed11593 (MS) - Ceraform
DilonTech17949 (MS) - Hemoblast Bellows
FCI11517 (MS) - Lacrijet
Newclip11561 (MS) - SCREW, FIXATION, BONE
Newclip11561 (MS) - Activ Ankle Locking Plate System
Newclip11561 (MS) - Alians Elbow Locking Plating System
Newclip11561 (MS) - Soft tissues protector
BBraun11480 (MS) - B. Braun Surgical, S.A. (Steelex)
FCI11517 (MS) - Retinal Strip
FCI11517 (MS) - Retinal Sleeve
FCI11517 (MS) - Retinal Band
FCI11517 (MS) - Retinal Sponge
Newclip11561 (MS) - Alians Clavicle range
Teknimed11593 (MS) - Osteofast Dental
BBraun11480 (MS) - B. Braun Surgical, S.A. (Silkam)
Newclip11561 (MS) - ACTIV Ankle countersink; Alians elbow countersink; Alians ulnar countersinkClaviclePlatecountersink;
Newclip11561 (MS) - Humerus reamer w/ quick coupling system; Large screw countersink; Large screw reamer tip
Newclip11561 (MS) - Foot & Hand Motion countersink; Foot & Hand Motion pre-tapering reamer;
Newclip11561 (MS) - HammerToe convex / concave reamers; HammerToe punch; HammerToe reamer; HTO countersink
FCI11517 (MS) - PVP perforated plug
BBraun11480 (MS) - B. Braun Surgical, S.A. (Dafilon)
Euroteknika14350 (MS) - iphysio® Profile Designer
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;
Newclip11561 (MS) - Foot and Hand Motion Range
FCI11517 (MS) - PRELOADED PUNCTAL PLUG (regular) J.A. BERNARD
FCI11517 (MS) - READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI
FCI11517 (MS) - PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (SMALL)
FCI11517 (MS) - PRELOADED PUNCTAL PLUG (EXTRA SMALL) - J.A. BERNARD
FCI11517 (MS) - PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (LARGE)
FCI11517 (MS) - PRELOADED PUNCTAL PLUG (SMALL) - J.A. BERNARD
FCI11517 (MS) - PRELOADED PUNCTAL PLUG (large)
Newclip11561 (MS) - Xpert Wrist
Newclip11561 (MS) - Activ Ankle
Teknimed11593 (MS) - Bonefuse; TRIHA+
FCI11517 (MS) - Retinal Tire
BBraun11480 (MS) - B. Braun Surgical, S.A. (Premicron)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)