510k
Database
Specialties
Anesthesiology
411
Cardiovascular
1245
Chemistry
309
Dental
942
Ear, Nose, Throat
181
Gastroenterology & Urology
732
General & Plastic Surgery
1593
General Hospital
989
Hematology
113
Immunology
80
Medical Genetics
6
Microbiology
402
Neurology
695
Obstetrics & Gynecology
302
Ophthalmic
185
Orthopedic
2255
Pathology
43
Physical Medicine
371
Radiology
1815
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
HRS
Plate, Fixation, Bone
222
GEI
Electrosurgical, Cutting &...
222
OLO
Orthopedic Stereotaxic Instrument
185
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
154
MAX
Intervertebral Fusion Device...
149
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Biomedical Ent., Inc.
Medical Device Manufacturer
·
US , San Antonio , TX
Biomedical Ent., Inc. - FDA 510(k) Cleared Devices
13 submissions
·
13 cleared
·
Since 1996
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomedical Ent., Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 29, 1997
BONE AND MARROW COLLECTION SYSTEM KIT
K971782
·
GEY
General & Plastic Surgery
·
76d
Cleared
Nov 14, 1996
BME BONE DRILL BITS
K964073
·
GEY
General & Plastic Surgery
·
34d
Cleared
Aug 06, 1996
BONE & MARROW COLLECTION SYSTEM
K961901
·
GEY
General & Plastic Surgery
·
82d
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13
Orthopedic
8
General & Plastic Surgery
3
Neurology
1
Dental
1