510k
Database
Specialties
Anesthesiology
445
Cardiovascular
1357
Chemistry
333
Dental
1051
Ear, Nose, Throat
194
Gastroenterology & Urology
805
General & Plastic Surgery
1771
General Hospital
1195
Hematology
120
Immunology
84
Medical Genetics
7
Microbiology
419
Neurology
760
Obstetrics & Gynecology
333
Ophthalmic
209
Orthopedic
2417
Pathology
44
Physical Medicine
405
Radiology
1964
Toxicology
142
Categories
GEX
Powered Laser Surgical Instrument
288
LLZ
System, Image Processing,...
280
GEI
Electrosurgical, Cutting &...
251
QIH
Automated Radiological Image...
250
IYN
System, Imaging, Pulsed Doppler,...
239
HRS
Plate, Fixation, Bone
235
LZA
Polymer Patient Examination Glove
200
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
NKB
Thoracolumbosacral Pedicle Screw...
167
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Fidelity Medical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Fidelity Medical, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1984
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fidelity Medical, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 29, 1991
LP-PLUS
K903774
·
DPS
Cardiovascular
·
374d
Cleared
Jan 06, 1988
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
K872928
·
DQK
Cardiovascular
·
163d
Cleared
Jun 16, 1987
LP-3 ELECTROCARDIOGRAPH
K864614
·
DPS
Cardiovascular
·
204d
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8
Radiology
4
Cardiovascular
3
General Hospital
1