510k
Database
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Anesthesiology
494
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1528
Chemistry
348
Dental
1203
Ear, Nose, Throat
222
Gastroenterology & Urology
884
General & Plastic Surgery
2009
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1551
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125
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90
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8
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437
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871
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386
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254
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2610
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49
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471
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2182
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153
Categories
GEX
Powered Laser Surgical Instrument
327
LLZ
System, Image Processing,...
323
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Polymer Patient Examination Glove
298
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Electrosurgical, Cutting &...
279
QIH
Automated Radiological Image...
265
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
188
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Warm & Form, Orthopedic Materials
Medical Device Manufacturer
·
US , Mchenry , IL
Warm & Form, Orthopedic Materials - FDA 510(k) Cleared Devices
24 submissions
·
24 cleared
·
Since 1982
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Warm & Form, Orthopedic Materials
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 30, 1982
UNIVERSAL BUCKS TRACTION
K823660
·
KQZ
Orthopedic
·
24d
Cleared
Nov 10, 1982
UNIVERSAL BUCKS TRACTION
K823163
·
KQZ
Orthopedic
·
16d
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24
Physical Medicine
20
Orthopedic
2
Neurology
1
Chemistry
1