MVR
9 FDA 510(k) clearances · Product code
61 daysmedian time to decision
196 days90th percentile
9clearances measured
FDA profile
- Official device name
- Device, Anastomotic, Microvascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 35 · 2022: 18 · 2023: 28 · 2024: 38 · 2025: 92 · 2026: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Gem FlowCoupler System (K190499) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
| Gem FlowCoupler System (K191252) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 |
| GEM Flow COUPLER Device and System (K143589) | Synovis Life Technologies, Inc. | 2015-01-16 |
| GEM Flow COUPLER Device and System (K142309) | Synovis Life Technologies, Inc. | 2014-09-16 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K132727) | Synovis Life Technologies, Inc. | 2013-10-22 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K093310) | Synovis Micro Companies Alliance, Inc. | 2010-02-01 |
| VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (K090679) | Vioptix, Inc. | 2009-04-17 |
| MICROVASCULAR ANASTOMOTIC DEVICE (K040163) | Synovis Micro Companies Alliance, Inc. | 2004-04-16 |
| 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) (K861985) | 3M Company | 1986-12-04 |
Track MVR automatically
Every clearance here is in the API, with alerts when new ones post.