510k
Database
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Anesthesiology
473
Cardiovascular
1425
Chemistry
334
Dental
1121
Ear, Nose, Throat
209
Gastroenterology & Urology
836
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1882
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1403
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125
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87
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8
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424
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810
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356
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235
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2468
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48
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430
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2052
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145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
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Polymer Patient Examination Glove
266
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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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(Ems Sa) Electro Medical Systems
Medical Device Manufacturer
·
US , North Attleboro , MA
(Ems Sa) Electro Medical Systems - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1999
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - (Ems Sa) Electro Medical Systems
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 14, 2007
AIR-FLOW MASTER STANDARD
K073284
·
EFB
Dental
·
23d
Cleared
Oct 27, 2003
SWISS MASTER LIGHT
K032099
·
EBZ
Dental
·
111d
Cleared
Jan 27, 2000
EMS KERMIT
K992504
·
ELC
Dental
·
184d
Cleared
Jul 30, 1999
EMS SURFACE MOUNT SCALER
K991874
·
ELC
Dental
·
58d
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5
Dental
4
Orthopedic
1