510k
Database
Specialties
Anesthesiology
8314
Cardiovascular
17274
Chemistry
12491
Dental
12031
Ear, Nose, Throat
3577
Gastroenterology & Urology
9399
General & Plastic Surgery
17417
General Hospital
16803
Hematology
3043
Immunology
3541
Medical Genetics
20
Microbiology
6678
Neurology
5994
Obstetrics & Gynecology
4292
Ophthalmic
4726
Orthopedic
17839
Pathology
1044
Physical Medicine
4901
Radiology
15083
Toxicology
2925
Categories
Powered Laser Surgical Instrument
GEX
2871
System, Image Processing, Radiological
LLZ
2286
Electrosurgical, Cutting &...
GEI
2266
Latex Patient Examination Glove
LYY
1954
Implant, Endosseous, Root-form
DZE
1529
Laparoscope, General & Plastic Surgery
GCJ
1429
Plate, Fixation, Bone
HRS
1325
Hearing Aid, Air-conduction,...
ESD
1249
System, Imaging, Pulsed Doppler,...
IYN
1182
Polymer Patient Examination Glove
LZA
1181
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Episafe Medical Devices, Ltd.
Share
Medical Device Manufacturer
·
US , Somerset , MA
Episafe Medical Devices, Ltd. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2005
Recent clearances:
EPIGUARD
View 1 510(k) Devices ↓
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Episafe Medical Devices, Ltd.
Neurology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 27, 2005
EPIGUARD
K050188
·
JXL
Neurology
·
90d
Filters
Filter by Specialty
All
1
Neurology
1