510k
Database
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Anesthesiology
1081
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4374
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3249
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2793
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467
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2400
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4109
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3801
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803
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782
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15
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1608
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1755
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878
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495
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7543
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166
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963
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4616
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1239
Categories
LLZ
System, Image Processing,...
727
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Plate, Fixation, Bone
689
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Electrosurgical, Cutting &...
568
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
520
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
464
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
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Manufacturers
US
Bio Clinic Co.
Medical Device Manufacturer
·
US , Riverside , CA
Bio Clinic Co. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 1988
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio Clinic Co.
Physical Medicine
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 21, 1993
PRISM
K932480
·
IOQ
Physical Medicine
·
58d
Cleared
Jun 24, 1993
ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE
K926189
·
IOQ
Physical Medicine
·
198d
Cleared
May 27, 1992
ORTHODERM CONVERTIBLE II
K922140
·
IOQ
Physical Medicine
·
21d
Cleared
Nov 27, 1990
BIO MEDX AIR FLOTATION SYSTEM
K905156
·
IOQ
Physical Medicine
·
12d
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14
Chemistry
7
Physical Medicine
4
General Hospital
3