510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
247
Gastroenterology & Urology
971
General & Plastic Surgery
2192
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2922
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
304
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Medical, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Medical, Inc. - FDA 510(k) Cleared Devices
21 submissions
·
20 cleared
·
Since 1977
21
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medical, Inc.
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 26, 1980
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM
K801451
·
FJG
Gastroenterology & Urology
·
95d
Cleared
May 08, 1979
HEMOCLEAR U-NEPHROS 1.0 DIALYZER
K790758
·
FJG
Gastroenterology & Urology
·
21d
Cleared
Dec 15, 1978
DIALYZER, PARALLEL FLOW DISPOSABLE
K781795
·
FJG
Gastroenterology & Urology
·
51d
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21
Cardiovascular
11
Anesthesiology
4
Gastroenterology & Urology
3
General Hospital
3