510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2201
General Hospital
2052
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
472
Neurology
969
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2961
Pathology
52
Physical Medicine
515
Radiology
2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Den-Mat Holdings, LLC
Medical Device Manufacturer
·
US , Santa Maria , CA
Den-Mat Holdings, LLC - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2008
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Den-Mat Holdings, LLC
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 10, 2011
SPPHINE PLUS STM 3W DIODE LASER
K110079
·
GEX
General & Plastic Surgery
·
30d
Cleared
Dec 29, 2010
SAPPHIRE ST PORTABLE DIODE LASER
K103667
·
GEX
General & Plastic Surgery
·
14d
Filters
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8
Dental
6
General & Plastic Surgery
2