510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1464
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1920
General Hospital
1456
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
826
Obstetrics & Gynecology
364
Ophthalmic
245
Orthopedic
2516
Pathology
49
Physical Medicine
444
Radiology
2084
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
IYN
System, Imaging, Pulsed Doppler,...
248
HRS
Plate, Fixation, Bone
248
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Smith and Nephew Donjoy, Inc.
Medical Device Manufacturer
·
US , Carsbad , CA
Smith and Nephew Donjoy, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
12 cleared
·
Since 1991
15
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smith and Nephew Donjoy, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 12, 1996
WHEEL CHAIR ACCESSORY
K963489
·
FMQ
General Hospital
·
70d
Cleared
Nov 12, 1996
PROTECTIVE RESTRAINT - BELTS
K963490
·
FMQ
General Hospital
·
70d
Cleared
Nov 12, 1996
PROTECTIVE RESTRAINT
K963492
·
FMQ
General Hospital
·
70d
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15
Orthopedic
5
Neurology
4
General Hospital
3
Physical Medicine
2
General & Plastic Surgery
1