510k
Database
Specialties
Anesthesiology
519
Cardiovascular
1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
General & Plastic Surgery
2126
General Hospital
1959
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
938
Obstetrics & Gynecology
425
Ophthalmic
271
Orthopedic
2691
Pathology
52
Physical Medicine
511
Radiology
2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Path Medical GmbH
Medical Device Manufacturer
·
US , Fort Collins , CO
Path Medical GmbH - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2010
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Path Medical GmbH
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 03, 2022
QScreen
K220139
·
GWJ
Ear, Nose, Throat
·
197d
Cleared
Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced,...
K213345
·
EWO
Ear, Nose, Throat
·
257d
Cleared
Oct 14, 2021
ALGO 7i
K211147
·
GWJ
Ear, Nose, Throat
·
178d
Cleared
Jun 09, 2014
SENTIERO
K133012
·
EWO
Ear, Nose, Throat
·
257d
Filters
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6
Ear, Nose, Throat
4
Neurology
2