510k
Database
Specialties
Anesthesiology
524
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
941
Obstetrics & Gynecology
427
Ophthalmic
272
Orthopedic
2701
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
FXX
Mask, Surgical
354
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Micro Direct, Inc.
Medical Device Manufacturer
·
US , Auburn , ME
Micro Direct, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1994
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Micro Direct, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
May 19, 2004
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
K033688
·
NRH
Chemistry
·
177d
Cleared
Jan 24, 1997
MICRO H2
K963376
·
NRH
Chemistry
·
150d
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9
Anesthesiology
6
Chemistry
2
General Hospital
1