510k
Database
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Anesthesiology
473
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1434
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335
Dental
1128
Ear, Nose, Throat
210
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839
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1888
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1423
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125
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87
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8
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426
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811
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360
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236
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2471
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49
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434
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2057
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145
Categories
GEX
Powered Laser Surgical Instrument
306
LLZ
System, Image Processing,...
304
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Polymer Patient Examination Glove
273
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Electrosurgical, Cutting &...
260
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Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Pacific Materials and Interfaces
Medical Device Manufacturer
·
US , San Diego , CA
Pacific Materials and Interfaces - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pacific Materials and Interfaces
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 30, 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913
·
HRS
Orthopedic
·
357d
Cleared
Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
K972327
·
JDQ
Orthopedic
·
49d
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3
Orthopedic
2
Dental
1