510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1425
Chemistry
334
Dental
1122
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1885
General Hospital
1408
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
810
Obstetrics & Gynecology
356
Ophthalmic
235
Orthopedic
2468
Pathology
48
Physical Medicine
432
Radiology
2053
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
LZA
Polymer Patient Examination Glove
268
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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G.W.B. Intl., Ltd.
Medical Device Manufacturer
·
US , Sudbury , MA
G.W.B. Intl., Ltd. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1990
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - G.W.B. Intl., Ltd.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 12, 1990
DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
K896029
·
IYO
Radiology
·
87d
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8
Ophthalmic
7
Radiology
1