510k
Database
Specialties
Anesthesiology
494
Cardiovascular
1532
Chemistry
349
Dental
1208
Ear, Nose, Throat
223
Gastroenterology & Urology
889
General & Plastic Surgery
2016
General Hospital
1567
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
438
Neurology
877
Obstetrics & Gynecology
387
Ophthalmic
255
Orthopedic
2616
Pathology
49
Physical Medicine
474
Radiology
2189
Toxicology
153
Categories
GEX
Powered Laser Surgical Instrument
329
LLZ
System, Image Processing,...
325
LZA
Polymer Patient Examination Glove
304
GEI
Electrosurgical, Cutting &...
281
QIH
Automated Radiological Image...
266
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
254
OLO
Orthopedic Stereotaxic Instrument
215
NHA
Abutment, Implant, Dental,...
202
MAX
Intervertebral Fusion Device...
189
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Geny Medical, Inc.
Medical Device Manufacturer
·
US , Aliso Viejo , CA
Geny Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1979
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Geny Medical, Inc.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 30, 2000
GENYX FLEXIBLE INJECTION NEEEDLE
K001146
·
FBK
Gastroenterology & Urology
·
81d
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2
Gastroenterology & Urology
1
Orthopedic
1