510k
Database
Specialties
Anesthesiology
1352
Cardiovascular
5022
Chemistry
3888
Dental
2896
Ear, Nose, Throat
488
Gastroenterology & Urology
2598
General & Plastic Surgery
4306
General Hospital
3995
Hematology
983
Immunology
936
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15
Microbiology
1963
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1924
Obstetrics & Gynecology
914
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507
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8244
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188
Physical Medicine
978
Radiology
5349
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1325
Categories
LLZ
System, Image Processing,...
768
HRS
Plate, Fixation, Bone
696
IYN
System, Imaging, Pulsed Doppler,...
631
GEI
Electrosurgical, Cutting &...
582
GEX
Powered Laser Surgical Instrument
527
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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510k Database
Manufacturers
US
Perfect Ear
Medical Device Manufacturer
·
US , Lake Mary , FL
Perfect Ear - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1993
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Perfect Ear
Ear, Nose, Throat
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 04, 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC,...
K973972
·
ESD
Ear, Nose, Throat
·
15d
Cleared
Apr 04, 1996
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
K960410
·
ESD
Ear, Nose, Throat
·
66d
Cleared
Jun 08, 1993
PERFECT EAR/PE
K931984
·
ESD
Ear, Nose, Throat
·
47d
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3
Ear, Nose, Throat
3