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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kentec Medical, Inc. with 9 device recalls and 6 510(k) clearances. The most recent is a device recall dated Jun 23, 2017: POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 23, 2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 fClass II · Inadequate detectability of radiopaque stripes | Device recalls |
| Jun 23, 2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-Class II · Inadequate detectability of radiopaque stripes | Device recalls |
| Feb 17, 2012 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETK120272 · KNT | 510(k) clearances |
| Apr 22, 2010 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEK100526 · FPD | 510(k) clearances |
| Sep 2, 2005 | ACCU-LEADK050443 · DRX | 510(k) clearances |
| Aug 25, 1997 | ACCUTEMP-PROBEK970686 · FMT | 510(k) clearances |
| May 1, 1996 | ACCUTEMP PROBEK960080 · FMT | 510(k) clearances |
| Sep 5, 1985 | GRAM-MA NEONATAL SCK853475 · FRW | 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
