510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2923
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Kerecis Limited
Medical Device Manufacturer
·
IS , Isafjordur
Kerecis Limited - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2013
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kerecis Limited
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 13, 2020
Kerecis Gingiva Graft
K192612
·
NPL
Dental
·
420d
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10
General & Plastic Surgery
8
Orthopedic
1
Dental
1