510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
Pathology
18
Physical Medicine
86
Radiology
870
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
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Purgo Biologics, Inc.
Medical Device Manufacturer
·
KR , Seongnam-Si
Purgo Biologics, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2018
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Purgo Biologics, Inc.
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Jul 24, 2024
THE Graft Collagen
K230305
·
NPM
Dental
·
537d
Cleared
Oct 06, 2023
THE Cover
K230091
·
NPL
Dental
·
267d
Cleared
May 11, 2023
OpenTex
K222549
·
NPK
Dental
·
261d
Cleared
Feb 14, 2020
The Graft Bone Substitute
K191737
·
NPM
Dental
·
231d
Cleared
Jul 20, 2018
The Graft Natural Bone Substitute
K173188
·
NPM
Dental
·
291d
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6
Dental
5
General & Plastic Surgery
1