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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Unoplast A/S
Medical Device Manufacturer
·
US , Mchenry , IL
Unoplast A/S - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1980
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unoplast A/S
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 21, 1990
FEEDING TUBE
K896734
·
FPD
Gastroenterology & Urology
·
386d
Cleared
Nov 05, 1990
NELATON-, FEMALE - OR TIEMANN CATHETER
K896729
·
KOD
Gastroenterology & Urology
·
340d
Cleared
Nov 02, 1990
UNOMETER 500
K896732
·
EXR
Gastroenterology & Urology
·
337d
Filters
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All
7
Gastroenterology & Urology
3
Anesthesiology
2
General & Plastic Surgery
2