510k
Database
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Anesthesiology
436
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1329
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327
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1022
Ear, Nose, Throat
192
Gastroenterology & Urology
789
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1737
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1141
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117
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84
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7
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413
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744
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327
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203
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2388
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44
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398
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1924
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141
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GEX
Powered Laser Surgical Instrument
285
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System, Image Processing,...
273
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Automated Radiological Image...
247
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Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
196
NHA
Abutment, Implant, Dental,...
183
LZA
Polymer Patient Examination Glove
182
MAX
Intervertebral Fusion Device...
165
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Pck Electronic Industry and Trade Co, Ltd.
Medical Device Manufacturer
·
TR , Ankara
Pck Electronic Industry and Trade Co, Ltd. - FDA 510(k) Cleared Devic...
2 submissions
·
2 cleared
·
Since 2001
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pck Electronic Industry and Trade Co, Ltd.
Gastroenterology & Urology
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 11, 2002
STONELITH, MODEL V5
K011106
·
LNS
Gastroenterology & Urology
·
306d
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2
Gastroenterology & Urology
1
Radiology
1