510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
317
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
522
General Hospital
373
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
233
Neurology
171
Obstetrics & Gynecology
62
Ophthalmic
50
Orthopedic
1295
Pathology
18
Physical Medicine
87
Radiology
871
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by Kerecis Limited
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jun 04, 2025
Tendon Protect (50242)
K243843
·
OWY
Orthopedic
·
173d
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10
General & Plastic Surgery
8
Dental
1
Orthopedic
1