510k
Database
Specialties
Anesthesiology
471
Cardiovascular
1413
Chemistry
334
Dental
1116
Ear, Nose, Throat
208
Gastroenterology & Urology
833
General & Plastic Surgery
1862
General Hospital
1361
Hematology
124
Immunology
87
Medical Genetics
7
Microbiology
423
Neurology
804
Obstetrics & Gynecology
354
Ophthalmic
232
Orthopedic
2462
Pathology
48
Physical Medicine
427
Radiology
2037
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
301
LLZ
System, Image Processing,...
300
GEI
Electrosurgical, Cutting &...
258
QIH
Automated Radiological Image...
255
LZA
Polymer Patient Examination Glove
246
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
202
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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B. Braun of America, Inc.
Medical Device Manufacturer
·
US , Bethlehem , PA
B. Braun of America, Inc. - FDA 510(k) Cleared Devices
19 submissions
·
16 cleared
·
Since 1991
19
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - B. Braun of America, Inc.
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 21, 1993
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285
·
DQK
Cardiovascular
·
274d
Cleared
Feb 27, 1992
GUIDEWIRE INTRODUCER SET
K915421
·
DYB
Cardiovascular
·
87d
Filters
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19
General Hospital
11
Gastroenterology & Urology
2
Cardiovascular
2
Anesthesiology
2
General & Plastic Surgery
1
Radiology
1