Panels › Obstetrics/Gynecology › Product code HFN · Class 2
Transducer, Pressure, Intrauterine
Regulation 884.2700
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HFN
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Innovations, Inc. | 4 | 0 |
| Utah Medical Products, Inc. | 2 | 1 |
| Telos Medical Corp. | 2 | 0 |
| Laurel Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2025 | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) Clinical Innovations, LLC | HFN |
| Feb 19, 1998 | K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. | HFN |
| Nov 24, 1997 | K973746 | PRE-FILLED SYRINGE FOR KOALA IUP Clinical Innovations, Inc. | HFN |
| Jul 10, 1996 | K961424 | INTRAN 500 Utah Medical Products, Inc. | HFN |
| Apr 17, 1996 | K954955 | STORC INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. | HFN |
| Feb 20, 1996 | K955443 | INTRAN PLUS Utah Medical Products, Inc. | HFN |
| Oct 27, 1992 | K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER Telos Medical Corp. | HFN |
| Oct 12, 1989 | K882224 | ULTRANS DISPOSABLE INTRAUTERINE Telos Medical Corp. | HFN |
| Jun 12, 1989 | K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS Laurel Medical Corp. | HFN |
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