510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1703
Chemistry
377
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
981
General & Plastic Surgery
2215
General Hospital
2065
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
439
Ophthalmic
282
Orthopedic
2995
Pathology
52
Physical Medicine
515
Radiology
2474
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
303
HRS
Plate, Fixation, Bone
287
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Radiometer America, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Radiometer America, Inc. - FDA 510(k) Cleared Devices
50 submissions
·
50 cleared
·
Since 1983
50
Total
50
Cleared
0
Denied
FDA 510(k) Regulatory Record - Radiometer America, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333
·
LKD
Anesthesiology
·
83d
Cleared
Sep 05, 1989
OXIMETER
K893587
·
DQA
Anesthesiology
·
119d
Cleared
Jun 08, 1987
OXIMETER
K871353
·
DQA
Anesthesiology
·
63d
Cleared
May 18, 1983
QUALISTICK ARTERIAL BLOOD SAMPLER
K831034
·
CBT
Anesthesiology
·
48d
Filters
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All
50
Chemistry
34
Microbiology
9
Anesthesiology
4
Hematology
2
General Hospital
1