510k
Database
Specialties
Anesthesiology
409
Cardiovascular
1235
Chemistry
308
Dental
930
Ear, Nose, Throat
179
Gastroenterology & Urology
726
General & Plastic Surgery
1585
General Hospital
981
Hematology
113
Immunology
79
Medical Genetics
4
Microbiology
400
Neurology
689
Obstetrics & Gynecology
297
Ophthalmic
183
Orthopedic
2239
Pathology
43
Physical Medicine
370
Radiology
1811
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
260
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
GEI
Electrosurgical, Cutting &...
221
HRS
Plate, Fixation, Bone
219
OLO
Orthopedic Stereotaxic Instrument
183
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
148
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Cook Vascular, Inc.
Medical Device Manufacturer
·
US , Leechburg , PA
Cook Vascular, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2001
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook Vascular, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 16, 2011
DOPPLER MONITOR
K110347
·
DPW
Radiology
·
37d
Cleared
Sep 06, 2002
COOK-SWARTZ DOPPLER FLOW PROBE
K022649
·
ITX
Radiology
·
28d
Cleared
Dec 18, 2001
SHAPEABLE DOPPLER FLOW PROBE
K002958
·
ITX
Radiology
·
452d
Filters
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12
Cardiovascular
6
Radiology
3
General Hospital
2
General & Plastic Surgery
1