510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1507
Chemistry
344
Dental
1189
Ear, Nose, Throat
220
Gastroenterology & Urology
866
General & Plastic Surgery
1967
General Hospital
1526
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
436
Neurology
863
Obstetrics & Gynecology
378
Ophthalmic
252
Orthopedic
2587
Pathology
49
Physical Medicine
461
Radiology
2159
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
319
LLZ
System, Image Processing,...
319
LZA
Polymer Patient Examination Glove
295
GEI
Electrosurgical, Cutting &...
276
QIH
Automated Radiological Image...
263
IYN
System, Imaging, Pulsed Doppler,...
258
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
201
MAX
Intervertebral Fusion Device...
183
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Winn Hirsch & Assoc.
Medical Device Manufacturer
·
US , Mchenry , IL
Winn Hirsch & Assoc. - FDA 510(k) Cleared Devices
11 submissions
·
10 cleared
·
Since 1976
11
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Winn Hirsch & Assoc.
Physical Medicine
✕
1
devices
1-1 of 1
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Cleared
Feb 11, 1980
COTTON UNDER CAST PADDING
K800195
·
ITG
Physical Medicine
·
13d
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11
General & Plastic Surgery
6
Orthopedic
2
Physical Medicine
1
Cardiovascular
1
Ophthalmic
1