510k
Database
Specialties
Anesthesiology
434
Cardiovascular
1318
Chemistry
327
Dental
1015
Ear, Nose, Throat
192
Gastroenterology & Urology
784
General & Plastic Surgery
1721
General Hospital
1118
Hematology
117
Immunology
83
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7
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413
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737
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324
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199
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2378
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44
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394
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1913
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141
Categories
GEX
Powered Laser Surgical Instrument
283
LLZ
System, Image Processing,...
270
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Automated Radiological Image...
247
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Electrosurgical, Cutting &...
243
IYN
System, Imaging, Pulsed Doppler,...
234
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
195
NHA
Abutment, Implant, Dental,...
182
LZA
Polymer Patient Examination Glove
172
MAX
Intervertebral Fusion Device...
165
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Machnet BV
Medical Device Manufacturer
·
US , Deer Field , IL
Machnet BV - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Machnet BV
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 2002
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
K020289
·
LNH
Radiology
·
86d
Cleared
Feb 01, 2002
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
K013985
·
MOS
Radiology
·
60d
Cleared
Oct 24, 2001
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
K012491
·
MOS
Radiology
·
82d
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3
Radiology
3