Panels › Physical Medicine › Product code IRQ · Class 1
Unit, Heating, Powered
Regulation 890.5950
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in IRQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet Microfixation, LLC | 0 | 1 |
| Ferno | 1 | 0 |
| Fred Sammons, Inc. | 1 | 0 |
| Marda Medical, Inc. | 1 | 0 |
| Thermowave Medical Device Corp. | 1 | 0 |
| Tri W-G, Inc. | 1 | 0 |
| Tru-Eze Mfg. Co., Inc. | 1 | 0 |
| Whitehall/Div Columbus Mckennon Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2012 | Biomet Microfixation, LLC The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device.
Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***ST Terminated |
IRQ | None listed |
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