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
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941
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427
Ophthalmic
272
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2701
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52
Physical Medicine
514
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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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Med Systems
Medical Device Manufacturer
·
US , Santa Monica , CA
Med Systems - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1985
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Med Systems
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 21, 2003
ELECTRO FLO PERCUSSOR, MODEL 5000
K031876
·
BYI
Anesthesiology
·
157d
Cleared
Sep 27, 1995
OXY-GENERATOR
K941145
·
CAW
Anesthesiology
·
566d
Cleared
Dec 03, 1985
SERIES 2000 MEDS MASK
K853785
·
BSJ
Anesthesiology
·
84d
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3
Anesthesiology
3