510k
Database
Specialties
Anesthesiology
457
Cardiovascular
1390
Chemistry
334
Dental
1081
Ear, Nose, Throat
199
Gastroenterology & Urology
825
General & Plastic Surgery
1823
General Hospital
1279
Hematology
124
Immunology
85
Medical Genetics
7
Microbiology
420
Neurology
779
Obstetrics & Gynecology
345
Ophthalmic
218
Orthopedic
2439
Pathology
46
Physical Medicine
416
Radiology
2013
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
243
HRS
Plate, Fixation, Bone
240
LZA
Polymer Patient Examination Glove
222
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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United States Surgical, A Division of Tyco Healthc
Medical Device Manufacturer
·
US , Mchenry , IL
United States Surgical, A Division of Tyco Healthc - FDA 510(k) Clear...
218 submissions
·
200 cleared
·
Since 1977
218
Total
200
Cleared
0
Denied
FDA 510(k) Regulatory Record - United States Surgical, A Division of Tyco Healthc
Hematology
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 04, 1981
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199
·
GKF
Hematology
·
147d
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All
218
General & Plastic Surgery
146
Orthopedic
24
Obstetrics & Gynecology
13
Neurology
9
General Hospital
8
Gastroenterology & Urology
8
Ear, Nose, Throat
5
Cardiovascular
4
Hematology
1