510k
Database
Specialties
Anesthesiology
430
Cardiovascular
1306
Chemistry
327
Dental
1008
Ear, Nose, Throat
190
Gastroenterology & Urology
782
General & Plastic Surgery
1699
General Hospital
1106
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
412
Neurology
734
Obstetrics & Gynecology
321
Ophthalmic
199
Orthopedic
2367
Pathology
44
Physical Medicine
393
Radiology
1901
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
240
HRS
Plate, Fixation, Bone
232
IYN
System, Imaging, Pulsed Doppler,...
232
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
171
MAX
Intervertebral Fusion Device...
161
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W.L. Gore & Associates, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices
163 submissions
·
148 cleared
·
Since 1980
Official Website
163
Total
148
Cleared
0
Denied
FDA 510(k) Regulatory Record - W.L. Gore & Associates, Inc.
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 14, 2001
GORE INTRODUCER SHEATH
K013282
·
DBY
Immunology
·
73d
Filters
Filter by Specialty
All
163
Cardiovascular
62
General & Plastic Surgery
61
Dental
11
Orthopedic
7
Neurology
5
General Hospital
5
Gastroenterology & Urology
5
Radiology
4
Ophthalmic
1
Ear, Nose, Throat
1