Panels › General, Plastic Surgery › Product code KDD · Class 1
Kit, Surgical Instrument, Disposable
Regulation 878.4800
0510(k)s in 12 months (62 all time)
16recalls in 12 months (252 all time)
9recalls that name a 510(k)
Top companies in KDD
| Company | 510(k)s | Recalls |
|---|---|---|
| Beaver Visitec International, Inc. | 0 | 160 |
| Windstone Medical Packaging, Inc. | 0 | 17 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 13 |
| Biomet Microfixation, Inc. | 0 | 9 |
| Medline Industries, LP | 0 | 9 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Deroyal Industries, Inc. | 1 | 5 |
| Bioseal Corporation | 0 | 4 |
| Merit Medical Systems, Inc. | 0 | 4 |
| MICROspecialties, Inc. | 0 | 4 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2007 | DeRoyal Lafollette Assorted non- sterile Tracecarts (with sterile component(s));
DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non- Terminated |
KDD | None listed |
| Aug 29, 2007 | DeRoyal Lafollette Assorted sterile surgical kits/ trays:
DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02 Terminated |
KDD | None listed |
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