510k
Database
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Anesthesiology
445
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1357
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333
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1051
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194
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805
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1771
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1195
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120
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84
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7
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419
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760
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333
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209
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2417
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44
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405
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1964
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142
Categories
GEX
Powered Laser Surgical Instrument
288
LLZ
System, Image Processing,...
280
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Electrosurgical, Cutting &...
251
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Automated Radiological Image...
250
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System, Imaging, Pulsed Doppler,...
239
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
200
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
NKB
Thoracolumbosacral Pedicle Screw...
167
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Care Wise Medical Products Corp.
Medical Device Manufacturer
·
US , Morgan Hill , CA
Care Wise Medical Products Corp. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1989
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Care Wise Medical Products Corp.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 25, 1998
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
K982442
·
IZD
Radiology
·
42d
Cleared
Oct 14, 1992
C-TRAK BIOPSY SYSTEM
K922117
·
IZD
Radiology
·
162d
Cleared
Mar 14, 1990
ONCOPROBE II SYSTEM
K896588
·
IZD
Radiology
·
113d
Cleared
Jan 04, 1989
ONCOPROBE SYSTEM
K884770
·
IZD
Radiology
·
51d
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4
Radiology
4