510k
Database
Specialties
Anesthesiology
919
Cardiovascular
2974
Chemistry
994
Dental
2062
Ear, Nose, Throat
371
Gastroenterology & Urology
1779
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3320
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3113
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232
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226
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15
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915
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1459
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707
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467
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4609
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75
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654
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4110
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318
Categories
LLZ
System, Image Processing,...
700
GEX
Powered Laser Surgical Instrument
510
IYN
System, Imaging, Pulsed Doppler,...
501
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Polymer Patient Examination Glove
483
GEI
Electrosurgical, Cutting &...
475
HRS
Plate, Fixation, Bone
412
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
391
LNH
System, Nuclear Magnetic...
345
NKB
Thoracolumbosacral Pedicle Screw...
343
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Manufacturers
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Manufacturers
US
Paxmed International
Medical Device Manufacturer
·
US , San Diego , CA
Paxmed International - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2001
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Paxmed International
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 21, 2012
MTA-FILLAPEX
K113568
·
KIF
Dental
·
263d
Cleared
Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
K022038
·
DZE
Dental
·
21d
Cleared
Sep 28, 2001
UNIVERSAL DENTAL COPING (UDC)
K010467
·
DZE
Dental
·
224d
Cleared
Sep 20, 2001
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
K011223
·
DZE
Dental
·
153d
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4
Dental
4