Panels › General, Plastic Surgery › Product code GAX · Class 1
Tourniquet, Nonpneumatic
Regulation 878.5900
0510(k)s in 12 months (20 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in GAX
| Company | 510(k)s | Recalls |
|---|---|---|
| ICU Medical, Inc. | 0 | 3 |
| The Seaberg Company Inc | 0 | 3 |
| Abco Dealers, Inc. | 2 | 0 |
| Barretta Products, Research and Development, Inc. | 1 | 0 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 1 | 0 |
| Conphar, Inc. | 1 | 0 |
| Cp Medical | 1 | 0 |
| Dale Medical Products, Inc. | 1 | 0 |
| Degania Silicone , Ltd. | 1 | 0 |
| Dryden Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2021 | Mar-Med Co Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. Terminated |
GAX | K853472 |
| May 2, 2018 | The Seaberg Company Inc Part #: SAM XT-C, Model: Hi-Viz Blue Terminated |
GAX | None listed |
| May 2, 2018 | The Seaberg Company Inc Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian Terminated |
GAX | None listed |
| May 2, 2018 | The Seaberg Company Inc Part #: SAM XT-M, Model: Tactical Black or Military Terminated |
GAX | None listed |
| Aug 31, 2015 | Pyng Medical Corporation MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008;
MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010;
MATResponder Tourniquet and MATCombat Tourniquet are essentially the same pr Terminated |
GAX | None listed |
| Aug 20, 2014 | ICU Medical, Inc. Port Access Kit with MicroClave Clear Connector, Item No. B79104
BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via Terminated |
GAX | None listed |
| Aug 20, 2014 | ICU Medical, Inc. Cap Change Kit with MicroClave Clear Connector, Item No. B79103
BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via t Terminated |
GAX | None listed |
| Aug 20, 2014 | ICU Medical, Inc. CAP Change Kit w/MicroClave Clear, Item No. B78109
BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number Terminated |
GAX | None listed |
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