510k
Database
Specialties
Anesthesiology
491
Cardiovascular
1495
Chemistry
343
Dental
1179
Ear, Nose, Throat
216
Gastroenterology & Urology
860
General & Plastic Surgery
1942
General Hospital
1496
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
433
Neurology
850
Obstetrics & Gynecology
370
Ophthalmic
251
Orthopedic
2567
Pathology
49
Physical Medicine
455
Radiology
2127
Toxicology
148
Categories
GEX
Powered Laser Surgical Instrument
317
LLZ
System, Image Processing,...
314
LZA
Polymer Patient Examination Glove
287
GEI
Electrosurgical, Cutting &...
270
QIH
Automated Radiological Image...
262
IYN
System, Imaging, Pulsed Doppler,...
256
HRS
Plate, Fixation, Bone
251
OLO
Orthopedic Stereotaxic Instrument
213
NHA
Abutment, Implant, Dental,...
199
MAX
Intervertebral Fusion Device...
179
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Flexmedics
Medical Device Manufacturer
·
US , Minneapolis , MN
Flexmedics - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 1986
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Flexmedics
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Aug 18, 1995
FINESSE GUIDEWIRE CORONARY
K952430
·
DQX
Cardiovascular
·
86d
Cleared
Jun 27, 1995
FLEXFINDER GUIDEWIRE
K943390
·
DQX
Cardiovascular
·
348d
Cleared
May 23, 1990
FLEXMEDICS GUIDEWIRE .012 ONLY
K895899
·
DQX
Cardiovascular
·
229d
Cleared
Sep 26, 1989
FLEXMEDICS GUIDEWIRE
K893626
·
DQX
Cardiovascular
·
138d
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20
Dental
10
Cardiovascular
4
Gastroenterology & Urology
3
Orthopedic
2
General & Plastic Surgery
1