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Biomedical Ent., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133844SPEED TRIADApril 7, 2014
K133780SPEED XLMarch 19, 2014
K131640SMOOTH OR THREADED METALLIC BONE FASTENEROctober 16, 2013
K102107OSSTAPLE CHILLSeptember 3, 2010
K091951HAMMERLOCKFebruary 19, 2010
K023203OSSTAPLEOctober 17, 2002
K001353MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAMarch 13, 2001
K001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE March 13, 2001
K001219MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEMJune 21, 2000
K993714MEMOGRAPH STAPLE, WARM SYSTEMFebruary 25, 2000
K971782BONE AND MARROW COLLECTION SYSTEM KITJuly 29, 1997
K964073BME BONE DRILL BITSNovember 14, 1996
K961901BONE & MARROW COLLECTION SYSTEMAugust 6, 1996