Panels › General Hospital › Product code FMP · Class 1
Protector, Skin Pressure
Regulation 880.6450
0510(k)s in 12 months (23 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in FMP
| Company | 510(k)s | Recalls |
|---|---|---|
| Fibre Formations, Inc. | 2 | 0 |
| Fred Sammons, Inc. | 2 | 0 |
| 3M Company - Health Care Business | 0 | 1 |
| Abco Dealers, Inc. | 1 | 0 |
| Action Products, Inc. | 1 | 0 |
| Alba-Waldensian, Inc. | 1 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| Childrens Medical Ventures | 0 | 1 |
| Current Technologies, Inc. | 1 | 0 |
| EHOB, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2020 | EHOB, Inc. Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the Terminated |
FMP | None listed |
| Dec 1, 2015 | 3M Company - Health Care Business 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. Terminated |
FMP | None listed |
| Dec 16, 2014 | Philips Medical Systems, Inc. Gel-E Donut : 92025-A (Extra Small), 92025-B (Small),
92025-C (Medium) and Squishon 2 91033-2.
The products are intended to support and cradle a baby's head and/or body. Terminated |
FMP | None listed |
| Aug 20, 2014 | Childrens Medical Ventures Gel-E Donut, Squishon 2 gel pillows
Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement w Terminated |
FMP | None listed |
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