510k
Database
Specialties
Anesthesiology
518
Cardiovascular
1597
Chemistry
356
Dental
1294
Ear, Nose, Throat
234
Gastroenterology & Urology
924
General & Plastic Surgery
2124
General Hospital
1935
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
936
Obstetrics & Gynecology
425
Ophthalmic
270
Orthopedic
2688
Pathology
52
Physical Medicine
509
Radiology
2312
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
398
LLZ
System, Image Processing,...
364
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
320
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
Browse all 339 categories →
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Promedic, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Promedic, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
14 cleared
·
Since 1995
16
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Promedic, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 17, 2003
FENESTRATED INFUSION CATHETER
K024190
·
FRN
General Hospital
·
88d
Cleared
Jun 24, 1997
FILTER
K970102
·
CAH
General Hospital
·
162d
Cleared
Jun 14, 1995
PRESSURIZER
K951988
·
KZD
General Hospital
·
48d
Filters
Filter by Specialty
All
16
Anesthesiology
6
Gastroenterology & Urology
5
General Hospital
3
Obstetrics & Gynecology
1
General & Plastic Surgery
1