510k
Database
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Anesthesiology
1037
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4331
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3210
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2788
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464
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2366
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3957
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3646
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788
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776
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15
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1404
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1755
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859
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492
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7536
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165
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962
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4605
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1237
Categories
LLZ
System, Image Processing,...
725
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Plate, Fixation, Bone
689
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Electrosurgical, Cutting &...
560
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System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
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
Healthcheck Corp.
Medical Device Manufacturer
·
US , Cheshire , CT
Healthcheck Corp. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1984
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Healthcheck Corp.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489
·
LCX
Chemistry
·
133d
Cleared
Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946
·
LCX
Chemistry
·
27d
Cleared
Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281
·
LCX
Chemistry
·
35d
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9
Chemistry
3
Cardiovascular
3
General Hospital
2
Neurology
1