510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1722
Chemistry
385
Dental
1379
Ear, Nose, Throat
252
Gastroenterology & Urology
985
General & Plastic Surgery
2224
General Hospital
2088
Hematology
127
Immunology
101
Medical Genetics
8
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474
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983
Obstetrics & Gynecology
441
Ophthalmic
283
Orthopedic
3050
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52
Physical Medicine
515
Radiology
2497
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Organogenesis, Inc.
Medical Device Manufacturer
·
US , Canton , MA
Organogenesis, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1997
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Organogenesis, Inc.
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 30, 2007
FORTAGEN ORAL MEMBRANE
K071555
·
NPL
Dental
·
84d
Filters
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12
General & Plastic Surgery
11
Dental
1