510k
Database
Specialties
Anesthesiology
481
Cardiovascular
1457
Chemistry
338
Dental
1154
Ear, Nose, Throat
214
Gastroenterology & Urology
845
General & Plastic Surgery
1909
General Hospital
1449
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
427
Neurology
822
Obstetrics & Gynecology
363
Ophthalmic
239
Orthopedic
2506
Pathology
49
Physical Medicine
440
Radiology
2073
Toxicology
146
Categories
GEX
Powered Laser Surgical Instrument
310
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
280
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Sunmed, Inc.
Medical Device Manufacturer
·
US , Clearwater , FL
Sunmed, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1993
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sunmed, Inc.
Anesthesiology
✕
1
devices
1-1 of 1
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Cleared
Jun 01, 1993
SUNLITE LARYNGOSCOPE
K921263
·
CCW
Anesthesiology
·
442d
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4
Orthopedic
2
Gastroenterology & Urology
1
Anesthesiology
1