510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1449
Chemistry
338
Dental
1145
Ear, Nose, Throat
210
Gastroenterology & Urology
844
General & Plastic Surgery
1899
General Hospital
1445
Hematology
125
Immunology
89
Medical Genetics
8
Microbiology
426
Neurology
821
Obstetrics & Gynecology
363
Ophthalmic
238
Orthopedic
2490
Pathology
49
Physical Medicine
439
Radiology
2068
Toxicology
146
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
305
LZA
Polymer Patient Examination Glove
278
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
246
IYN
System, Imaging, Pulsed Doppler,...
246
OLO
Orthopedic Stereotaxic Instrument
204
NHA
Abutment, Implant, Dental,...
192
MAX
Intervertebral Fusion Device...
172
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Myocure, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Myocure, Inc. - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1982
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Myocure, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 17, 1986
SURGICAL SKIN MARKER
K864371
·
FZZ
General & Plastic Surgery
·
12d
Cleared
Aug 25, 1982
MYOCUR BLADE PAC
K822392
·
HMN
General & Plastic Surgery
·
16d
Filters
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15
Ophthalmic
12
General & Plastic Surgery
2
Radiology
1