Company ยท US
Biomedical Ent., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2014. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 2014 | K133844 | SPEED TRIAD Biomedical Ent., Inc. | JDR |
| Mar 19, 2014 | K133780 | SPEED XL Biomedical Ent., Inc. | JDR |
| Oct 16, 2013 | K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER Biomedical Ent., Inc. | HTY |
| Sep 3, 2010 | K102107 | OSSTAPLE CHILL Biomedical Ent., Inc. | JDR |
| Feb 19, 2010 | K091951 | HAMMERLOCK Biomedical Ent., Inc. | HTY |
| Oct 17, 2002 | K023203 | OSSTAPLE Biomedical Ent., Inc. | JDR |
| Mar 13, 2001 | K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. | JDR |
| Mar 13, 2001 | K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. | HBW |
| Jun 21, 2000 | K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. | JEY |
| Feb 25, 2000 | K993714 | MEMOGRAPH STAPLE, WARM SYSTEM Biomedical Ent., Inc. | JDR |
| Jul 29, 1997 | K971782 | BONE AND MARROW COLLECTION SYSTEM KIT Biomedical Ent., Inc. | GEY |
| Nov 14, 1996 | K964073 | BME BONE DRILL BITS Biomedical Ent., Inc. | GEY |
| Aug 6, 1996 | K961901 | BONE & MARROW COLLECTION SYSTEM Biomedical Ent., Inc. | GEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||