510k
Database
Specialties
Anesthesiology
430
Cardiovascular
1306
Chemistry
327
Dental
1004
Ear, Nose, Throat
190
Gastroenterology & Urology
781
General & Plastic Surgery
1697
General Hospital
1101
Hematology
117
Immunology
83
Medical Genetics
7
Microbiology
412
Neurology
732
Obstetrics & Gynecology
321
Ophthalmic
199
Orthopedic
2365
Pathology
44
Physical Medicine
393
Radiology
1898
Toxicology
140
Categories
GEX
Powered Laser Surgical Instrument
281
LLZ
System, Image Processing,...
267
QIH
Automated Radiological Image...
246
GEI
Electrosurgical, Cutting &...
239
IYN
System, Imaging, Pulsed Doppler,...
232
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
NKB
Thoracolumbosacral Pedicle Screw...
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.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089
·
MOS
Radiology
·
31d
Cleared
Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679
·
MOS
Radiology
·
17d
Cleared
Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810
·
MOS
Radiology
·
12d
Cleared
Sep 05, 1996
MINI FLEX COIL
K961628
·
MOS
Radiology
·
132d
Filters
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All
163
Cardiovascular
62
General & Plastic Surgery
61
Dental
11
Orthopedic
7
General Hospital
5
Gastroenterology & Urology
5
Neurology
5
Radiology
4
Ear, Nose, Throat
1
Immunology
1