Company ยท US
F.M. Wiest USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1994. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRX | Arthroscope | 3 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 2 |
| HIG | Insufflator, Hysteroscopic | 2 |
| EXQ | Cystometer, Electrical Recording | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1994 | K921871 | HYSTEROMAT(TM) 3700 F.M. Wiest USA, Inc. | HIG |
| Feb 17, 1993 | K920574 | CAMSYS 6300 F.M. Wiest USA, Inc. | EXQ |
| Jul 23, 1992 | K920575 | MERKUR 4000 F.M. Wiest USA, Inc. | FAP |
| Apr 24, 1992 | K915751 | URETEROMAT 4400 F.M. Wiest USA, Inc. | EZN |
| Nov 21, 1991 | K911844 | HYSTEROFLATOR 1500 F.M. Wiest USA, Inc. | HIG |
| Jul 9, 1991 | K912071 | SPACE(TM) 7500 F.M. Wiest USA, Inc. | IKN |
| Mar 29, 1991 | K910883 | LAPAROFLATOR ELECTRONIC 3509 F.M. Wiest USA, Inc. | HIF |
| Mar 2, 1988 | K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC F.M. Wiest USA, Inc. | HES |
| Sep 29, 1987 | K871181 | ARTHROCOMBI 5003 F.M. Wiest USA, Inc. | HRX |
| Sep 29, 1987 | K871180 | ARTHRO AUTOMAT 5002 F.M. Wiest USA, Inc. | HRX |
| Apr 20, 1987 | K865066 | ARTHROFLATOR F.M. Wiest USA, Inc. | HRX |
| Mar 18, 1986 | K860571 | F.M. WEIST,KG (URODYNAMIC SYSTEMS) F.M. Wiest USA, Inc. | FAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||