510k
Database
Specialties
Anesthesiology
445
Cardiovascular
1357
Chemistry
333
Dental
1051
Ear, Nose, Throat
194
Gastroenterology & Urology
805
General & Plastic Surgery
1771
General Hospital
1195
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
419
Neurology
760
Obstetrics & Gynecology
333
Ophthalmic
209
Orthopedic
2417
Pathology
44
Physical Medicine
405
Radiology
1964
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
288
LLZ
System, Image Processing,...
280
GEI
Electrosurgical, Cutting &...
251
QIH
Automated Radiological Image...
250
IYN
System, Imaging, Pulsed Doppler,...
239
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
200
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
NKB
Thoracolumbosacral Pedicle Screw...
167
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Howmedica, Inc.
Medical Device Manufacturer
·
US , Rutherford , NJ
Howmedica, Inc. - FDA 510(k) Cleared Devices
36 submissions
·
29 cleared
·
Since 1994
36
Total
29
Cleared
0
Denied
FDA 510(k) Regulatory Record - Howmedica, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 29, 1999
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885
·
JEY
Dental
·
88d
Cleared
Dec 02, 1997
CHIN DISTRACTOR
K973484
·
JEY
Dental
·
78d
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36
Orthopedic
33
Dental
2
Radiology
1