Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Catheter Research and its 1 subsidiaries with 16 510(k) clearances and 1 device recall. The most recent is a device recall dated Apr 7, 2015: HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hyst….
| Apr 7, 2015 | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecologicClass II · HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, | Device recalls |
| Jan 31, 2013 | THE ADVANCE CATHETER FOR HSG AND SISK123258 · LKF | 510(k) clearances |
| Mar 21, 2012 | INTRAUTERINE INSEMINATION (IUI) CATHETERK120154 · MQF | 510(k) clearances |
| Dec 11, 2003 | H/S CATHETER SETK032835 · LKF | 510(k) clearances |
| Apr 17, 2002 | UTERINE INJECTORK020292 · LKF | 510(k) clearances |
| Mar 19, 1998 | DISPOSABLE ESOPHAGEAL STETHOSCOPEK973839 · BZT | 510(k) clearances |
| Feb 2, 1998 | UTERINE MANIPULATOR/INJECTORK974357 · LKF | 510(k) clearances |
| Apr 14, 1995 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGK951345 · BZA | 510(k) clearances |
| Dec 27, 1994 | DISPOSABLE GAS SAMPLING LINESK946044 · CCK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
