510k
Database
Specialties
Anesthesiology
516
Cardiovascular
1596
Chemistry
356
Dental
1290
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2120
General Hospital
1920
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
935
Obstetrics & Gynecology
424
Ophthalmic
268
Orthopedic
2684
Pathology
52
Physical Medicine
508
Radiology
2305
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
393
LLZ
System, Image Processing,...
361
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
310
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Gereonics, Inc.
Medical Device Manufacturer
·
US , Escondido , CA
Gereonics, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1986
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gereonics, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 13, 2007
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883
·
BZQ
Anesthesiology
·
260d
Cleared
Apr 28, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411
·
BZQ
Anesthesiology
·
33d
Cleared
Feb 08, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449
·
BZQ
Anesthesiology
·
131d
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4
Anesthesiology
3
Cardiovascular
1