510k
Database
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Anesthesiology
1323
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4897
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3434
Dental
2813
Ear, Nose, Throat
475
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2513
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4251
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3893
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850
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801
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15
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1921
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1841
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893
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498
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8085
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176
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978
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5132
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1258
Categories
LLZ
System, Image Processing,...
757
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Plate, Fixation, Bone
696
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System, Imaging, Pulsed Doppler,...
579
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Electrosurgical, Cutting &...
570
GEX
Powered Laser Surgical Instrument
523
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
436
NKB
Thoracolumbosacral Pedicle Screw...
403
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Manufacturers
US
Impladent
Medical Device Manufacturer
·
US , Mchenry , IL
Impladent - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 1980
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Impladent
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
May 31, 1995
OSTEOGEN (HA RESORB)
K923310
·
LYC
Dental
·
1058d
Cleared
Sep 01, 1988
EXPANDED CLAIMES TO OSTEOGEN(R)
K881662
·
DZE
Dental
·
139d
Cleared
Dec 27, 1984
OSTEOGEN
K843398
·
LYC
Dental
·
120d
Cleared
Oct 29, 1981
HYDROXI-FLEX IMPLANT
K812321
·
DZE
Dental
·
73d
Cleared
Jan 09, 1980
FLEXI-CUP IMPLANT
K792663
·
DZE
Dental
·
14d
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Dental
5