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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2011 | K110900 | DISPOSABLE THYROID COLLAR Bloxr Corporation | KPY |
| Oct 1, 1996 | K962622 | INTRA-ORAL THERMOPLASTIC SHIELD Medtec, Inc. | KPY |
| Dec 21, 1995 | K954456 | THERMOPLASTIC SHIELD Medtec, Inc. | KPY |
| Dec 6, 1995 | K954146 | UTK-DTE AUTILARY SHIELD Mallinckrodt Medical | KPY |
| Sep 26, 1995 | K953610 | AUKULYTE Aukland Medical Plastics, Inc. | KPY |
| Apr 10, 1995 | K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) Kenex , Ltd., DE | KPY |
| Apr 3, 1995 | K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) Kenex , Ltd., GB | KPY |
| Mar 16, 1994 | K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM Standard Imaging, Inc. | KPY |
| Oct 7, 1993 | K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 F. Walter Hanel GmbH | KPY |
| Mar 18, 1992 | K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS Davis Lead Aprons, Inc. | KPY |
| Mar 18, 1992 | K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. Davis Lead Aprons, Inc. | KPY |
| Mar 18, 1992 | K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS Davis Lead Aprons, Inc. | KPY |
| May 1, 1990 | K900970 | RADIATION PROTECTION GLASSES Infab Corp. | KPY |
| Dec 22, 1989 | K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL E.I. Dupont DE Nemours & Co., Inc. | KPY |
| Dec 14, 1989 | K896289 | RADIATION PROTECTION APRON Infab Corp. | KPY |
| May 8, 1987 | K871502 | PERSONNEL PROTECTIVE SHIELD Cis-Us, Inc. | KPY |
| Dec 17, 1984 | K844160 | VENTIBOX Syncor Intl. Corp. | KPY |
| Jul 2, 1981 | K811677 | KRYPTON CART Medi-Physics Inc. Dba Nycomed Amersham Imaging | KPY |
| May 27, 1981 | K811068 | BYPASS COIL G.D. Searle and Co. | KPY |
| Feb 12, 1981 | K810095 | MOTI APRON Moti Enterprises, Inc. | KPY |
| Oct 31, 1980 | K802377 | MOTI PROTECTIVE X-RAY MASK Moti Enterprises, Inc. | KPY |
| Oct 26, 1979 | K791522 | FLOW MEDICAL X-RAY PROTECTIVE GLOVES Flow X-Ray Corp. | KPY |
| Apr 23, 1979 | K790639 | GONAD SHIELD The Mochlett Laboratories, Inc. | KPY |
| Jan 26, 1979 | K790080 | APRON, LEADED VINYL Pinnacle Distributors, Inc. | KPY |
| Nov 15, 1978 | K781852 | GLOVE, SUPERFLEX MOLDED Pinnacle Distributors, Inc. | KPY |
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