510k
Database
Specialties
Anesthesiology
516
Cardiovascular
1597
Chemistry
356
Dental
1292
Ear, Nose, Throat
234
Gastroenterology & Urology
924
General & Plastic Surgery
2123
General Hospital
1927
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
935
Obstetrics & Gynecology
425
Ophthalmic
269
Orthopedic
2686
Pathology
52
Physical Medicine
508
Radiology
2310
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
395
LLZ
System, Image Processing,...
364
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
315
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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Princeton BioMeditech Corp.
Medical Device Manufacturer
·
US , Monmouth Junction , NJ
Princeton BioMeditech Corp. - FDA 510(k) Cleared Devices
72 submissions
·
72 cleared
·
Since 1994
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - Princeton BioMeditech Corp.
Immunology
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024
·
KTN
Immunology
·
327d
Cleared
Aug 14, 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360
·
DDR
Immunology
·
103d
Filters
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All
72
Toxicology
43
Chemistry
14
Microbiology
10
Hematology
3
Immunology
2