510k
Database
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Anesthesiology
438
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1336
Chemistry
330
Dental
1033
Ear, Nose, Throat
192
Gastroenterology & Urology
795
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1754
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1160
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118
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84
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7
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414
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747
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329
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204
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2396
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44
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400
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1937
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141
Categories
GEX
Powered Laser Surgical Instrument
286
LLZ
System, Image Processing,...
276
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Electrosurgical, Cutting &...
248
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Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
188
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Wellington Medical Systems, Inc.
Medical Device Manufacturer
·
US , Dartmouth , MA
Wellington Medical Systems, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2000
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Wellington Medical Systems, Inc.
Radiology
✕
1
devices
1-1 of 1
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Cleared
Jun 13, 2000
DIGITAL INTEGRATION SYSTEM, DIS2000
K001012
·
LLZ
Radiology
·
76d
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Radiology
1