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.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 22, 1998
INSTACINE D-2000
K983088
·
LLZ
Radiology
·
25d
Cleared
May 30, 1995
INSTACINE
K942558
·
LMB
Radiology
·
364d
Cleared
May 05, 1995
INSTASPOT
K942504
·
LLZ
Radiology
·
344d
Cleared
Feb 24, 1995
FLUOROPLUA CARDIAC AND/OR INSTAVIEW
K941917
·
JAA
Radiology
·
311d
Filters
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8
Radiology
4
Cardiovascular
3
General Hospital
1