510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1073
Chemistry
272
Dental
822
Ear, Nose, Throat
149
Gastroenterology & Urology
636
General & Plastic Surgery
1334
General Hospital
768
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
367
Neurology
589
Obstetrics & Gynecology
247
Ophthalmic
155
Orthopedic
2062
Pathology
40
Physical Medicine
311
Radiology
1591
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
161
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
137
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Ortho Diagnostic Systems, Inc.
Medical Device Manufacturer
·
US , Carpinteria , CA
Ortho Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
126 submissions
·
126 cleared
·
Since 1981
126
Total
126
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162
·
HHT
Obstetrics & Gynecology
·
42d
Cleared
Jun 26, 1987
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552
·
HHT
Obstetrics & Gynecology
·
65d
Filters
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All
126
Hematology
54
Microbiology
40
Chemistry
22
Immunology
5
Toxicology
2
Obstetrics & Gynecology
2
Pathology
1