510k
Database
Specialties
Anesthesiology
483
Cardiovascular
1461
Chemistry
339
Dental
1159
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1915
General Hospital
1455
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
825
Obstetrics & Gynecology
364
Ophthalmic
242
Orthopedic
2513
Pathology
49
Physical Medicine
443
Radiology
2081
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
313
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
IYN
System, Imaging, Pulsed Doppler,...
247
HRS
Plate, Fixation, Bone
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Synemed, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Synemed, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1981
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synemed, Inc.
Ophthalmic
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 17, 1995
FIELD TREND
K954037
·
HPT
Ophthalmic
·
81d
Cleared
Oct 15, 1985
THE FIELDMASTER MODEL 275
K852936
·
HPT
Ophthalmic
·
97d
Cleared
Dec 03, 1983
DERMATOLOGY HANDPIECE-OPHTH LASER
K833274
·
HQF
Ophthalmic
·
73d
Cleared
Oct 18, 1982
MODEL 200 SQUID
K822853
·
HPT
Ophthalmic
·
21d
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8
Ophthalmic
4
Obstetrics & Gynecology
2
General & Plastic Surgery
1
Radiology
1