510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1709
Chemistry
380
Dental
1355
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2215
General Hospital
2079
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
282
Orthopedic
3023
Pathology
52
Physical Medicine
515
Radiology
2486
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
399
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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Burron Medical, Inc.
Medical Device Manufacturer
·
US , Bethlehem , PA
Burron Medical, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1988
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Burron Medical, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 06, 1990
COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT
K884235
·
DRS
Cardiovascular
·
515d
Cleared
Aug 03, 1989
BURRON TEFLON-COATED GUIDEWIRE
K884183
·
DQX
Cardiovascular
·
303d
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9
General Hospital
6
Cardiovascular
2
Anesthesiology
1