510k
Database
Specialties
Anesthesiology
532
Cardiovascular
1643
Chemistry
359
Dental
1318
Ear, Nose, Throat
242
Gastroenterology & Urology
955
General & Plastic Surgery
2169
General Hospital
2036
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
952
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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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) Regulatory Record - 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