510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1333
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
962
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2870
Pathology
52
Physical Medicine
515
Radiology
2429
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Med-Tek Innovations, Inc.
Medical Device Manufacturer
·
US , Glendale , WI
Med-Tek Innovations, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1991
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Med-Tek Innovations, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 13, 1994
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
K944194
·
BYD
Anesthesiology
·
15d
Cleared
Feb 03, 1993
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
K913474
·
BTM
Anesthesiology
·
548d
Cleared
Apr 09, 1991
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
K905288
·
BYG
Anesthesiology
·
134d
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3
Anesthesiology
3