FDA Registration
Active
🇺🇸 United States
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
Reg #: 1062741
·
FEI: 3000302153
·
Expires 2026
Products
18
Proprietary Names
18
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
- Registration Number
- 1062741
- FEI Number
- 3000302153
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 439 Industrial Ln
- City
- BIRMINGHAM
- State
- AL
- ZIP
- 35211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K861985
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anastomotic, Microvascular | MVR | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2015-12-07 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2023-12-05 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-06-08 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1991-04-01 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2017-12-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-12-07 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2015-12-07 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-11-04 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-11-04 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-11-24 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2015-12-07 |
Proprietary Names
Microvascular Anastomotic Device
Titanium Hemostatic Clip
RiverLon (Nylon) Suture
VTI Intraoperative Doppler Systems
GEM ZIPCLIP
GEM Biover Clamps
None
DermaClose Continous External Tissue Expander
DermaClose XL Continuous External Tissue Expander
Forceps
GEM Flow Coupler Device and System
Instrument Trays
Gem Flow Now (GEM2770-FN)
Anastomotic Instrument
GEM Sapphire Cordless LED Headlight
GEM FLOW COUPLER Monitor (GEM2010M-1)
GEM Flow COUPLER Monitor Power Cord
Non-absorbable Surgical Sutures: Polyblend, Polyester, Silk Propolyene, Nylon
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device