510k
Database
Specialties
Anesthesiology
338
Cardiovascular
1074
Chemistry
272
Dental
826
Ear, Nose, Throat
149
Gastroenterology & Urology
638
General & Plastic Surgery
1338
General Hospital
773
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
368
Neurology
589
Obstetrics & Gynecology
249
Ophthalmic
156
Orthopedic
2064
Pathology
40
Physical Medicine
312
Radiology
1596
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
NKB
Thoracolumbosacral Pedicle Screw...
138
MAX
Intervertebral Fusion Device...
138
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Burroughs Wellcome Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Burroughs Wellcome Co. - FDA 510(k) Cleared Devices
17 submissions
·
17 cleared
·
Since 1977
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Burroughs Wellcome Co.
Toxicology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 1978
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
K780475
·
DON
Toxicology
·
31d
Cleared
Sep 15, 1977
TOXHA TEST
K771560
·
GMM
Toxicology
·
31d
Cleared
Mar 16, 1977
CAMMADISK DIGOXIN
K770269
·
DON
Toxicology
·
33d
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17
Chemistry
6
Immunology
5
Toxicology
3
Microbiology
2
Pathology
1