Shield, Protective, Personnel
Regulation 892.6500
0510(k)s in 12 months (25 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in KPY
| Company | 510(k)s | Recalls |
|---|---|---|
| Davis Lead Aprons, Inc. | 3 | 0 |
| GE Healthcare | 0 | 2 |
| Infab Corp. | 2 | 0 |
| Kenex , Ltd. | 2 | 0 |
| Medtec, Inc. | 2 | 0 |
| Moti Enterprises, Inc. | 2 | 0 |
| Pinnacle Distributors, Inc. | 2 | 0 |
| Aukland Medical Plastics, Inc. | 1 | 0 |
| Bloxr Corporation | 1 | 0 |
| Cis-Us, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2015 | GE Healthcare Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Terminated |
KPY | None listed |
| Jun 3, 2014 | GE Healthcare, LLC Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Kenex Suspension installed with Radiation shield and lamp with following Terminated |
KPY | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.