510k
Database
Specialties
Anesthesiology
488
Cardiovascular
1482
Chemistry
342
Dental
1166
Ear, Nose, Throat
216
Gastroenterology & Urology
857
General & Plastic Surgery
1936
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
842
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2552
Pathology
49
Physical Medicine
455
Radiology
2111
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
310
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
261
IYN
System, Imaging, Pulsed Doppler,...
253
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Jerome Medical
Medical Device Manufacturer
·
US , Mchenry , IL
Jerome Medical - FDA 510(k) Cleared Devices
9 submissions
·
8 cleared
·
Since 1982
9
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jerome Medical
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 06, 1993
SYSTEM III HALO RING
K930153
·
JEC
Orthopedic
·
206d
Cleared
Sep 30, 1988
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K882877
·
JEC
Orthopedic
·
81d
Cleared
Mar 11, 1987
TORQUEDRIVER WRENCH
K870053
·
HXC
Orthopedic
·
63d
Cleared
Oct 06, 1982
CERVICAL BRACE
K822780
·
JEC
Orthopedic
·
22d
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9
Orthopedic
4
Neurology
2
Physical Medicine
2
General & Plastic Surgery
1