Medical Device Manufacturer · US , San Antonio , TX

Biomedical Ent., Inc.

13 submissions · 13 cleared · Since 1996
13
Total
13
Cleared
0
Denied

Biomedical Ent., Inc. — FDA 510(k) Submissions

Biomedical Ent., Inc. has submitted 13 FDA 510(k) premarket notifications since 1996, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Staple, Fixation, Bone, Motor, Surgical Instrument, Ac-powered, Pin, Fixation, Smooth, Plate, Bone, Fastener, Plate, Cranioplasty . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
SPEED TRIAD
K133844 · JDR Staple, Fixation, Bone · Orthopedic
Apr 2014 110d
SPEED XL
K133780 · JDR Staple, Fixation, Bone · Orthopedic
Mar 2014 97d
SMOOTH OR THREADED METALLIC BONE FASTENER
K131640 · HTY Pin, Fixation, Smooth · Orthopedic
Oct 2013 134d
OSSTAPLE CHILL
K102107 · JDR Staple, Fixation, Bone · Orthopedic
Sep 2010 38d
HAMMERLOCK
K091951 · HTY Pin, Fixation, Smooth · Orthopedic
Feb 2010 233d
OSSTAPLE
K023203 · JDR Staple, Fixation, Bone · Orthopedic
Oct 2002 22d
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
K001353 · HBW Fastener, Plate,... · Neurology
Mar 2001 319d
MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM
K001354 · JDR Staple, Fixation, Bone · Orthopedic
Mar 2001 319d
MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM
K001219 · JEY Plate, Bone · Dental
Jun 2000 65d
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · JDR Staple, Fixation, Bone · Orthopedic
Feb 2000 115d
BONE AND MARROW COLLECTION SYSTEM KIT
K971782 · GEY Motor, Surgical... · General & Plastic Surgery
Jul 1997 76d
BME BONE DRILL BITS
K964073 · GEY Motor, Surgical... · General & Plastic Surgery
Nov 1996 34d
BONE & MARROW COLLECTION SYSTEM
K961901 · GEY Motor, Surgical... · General & Plastic Surgery
Aug 1996 82d
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