Panels › Obstetrics/Gynecology › Product code HGE · Class 1
Amniotome
Regulation 884.4530
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Epcom Medical Systems, Inc. | 1 | 0 |
| Go Medical Industries Pty. , Ltd. | 1 | 0 |
| Imm Enterprises , Ltd. | 1 | 0 |
| Onli | 1 | 0 |
| Raymart Development Co. | 1 | 0 |
| Salt Creek Medical Technologies | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 1995 | K951148 | OBSTI-HOOK Onli | HGE |
| Mar 7, 1994 | K926425 | AMNIPERF(TM) Raymart Development Co. | HGE |
| May 9, 1991 | K910518 | GLOVE-N-GEL AMNIOTOMY KIT Epcom Medical Systems, Inc. | HGE |
| Mar 23, 1987 | K871087 | S.C.M.T. PERFORATOR Salt Creek Medical Technologies | HGE |
| Apr 15, 1985 | K850758 | AMNIGLOVE & AMNICOT Go Medical Industries Pty. , Ltd., AU | HGE |
| Dec 27, 1983 | K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 Imm Enterprises , Ltd. | HGE |
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