510k
Database
Specialties
Anesthesiology
553
Cardiovascular
1737
Chemistry
387
Dental
1407
Ear, Nose, Throat
258
Gastroenterology & Urology
997
General & Plastic Surgery
2247
General Hospital
2105
Hematology
127
Immunology
105
Medical Genetics
8
Microbiology
478
Neurology
988
Obstetrics & Gynecology
454
Ophthalmic
286
Orthopedic
3090
Pathology
52
Physical Medicine
517
Radiology
2519
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
368
FXX
Mask, Surgical
361
GEI
Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
239
MAX
Intervertebral Fusion Device...
235
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Inframed, Inc.
Medical Device Manufacturer
·
US , Brookline Village , MA
Inframed, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1985
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Inframed, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
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Cleared
Nov 14, 1985
CILAS MODEL YM101
K852761
·
LLO
Anesthesiology
·
139d
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3
General & Plastic Surgery
1
Anesthesiology
1
Neurology
1