510k
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Anesthesiology
484
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1475
Chemistry
340
Dental
1160
Ear, Nose, Throat
216
Gastroenterology & Urology
852
General & Plastic Surgery
1927
General Hospital
1467
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125
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90
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8
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432
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832
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368
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248
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2536
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49
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448
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2087
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147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
285
GEI
Electrosurgical, Cutting &...
266
QIH
Automated Radiological Image...
258
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
175
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T.E.M. Instruments , Ltd.
Medical Device Manufacturer
·
US , Mchenry , IL
T.E.M. Instruments , Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1981
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - T.E.M. Instruments , Ltd.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 10, 1981
P.R.M. 80
K810590
·
IZW
Radiology
·
37d
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Radiology
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