510k
Database
Specialties
Anesthesiology
1395
Cardiovascular
5312
Chemistry
3996
Dental
3028
Ear, Nose, Throat
517
Gastroenterology & Urology
2712
General & Plastic Surgery
4455
General Hospital
4034
Hematology
1015
Immunology
1130
Medical Genetics
15
Microbiology
2241
Neurology
1980
Obstetrics & Gynecology
982
Ophthalmic
541
Orthopedic
8275
Pathology
334
Physical Medicine
978
Radiology
5405
Toxicology
1326
Categories
LLZ
System, Image Processing,...
777
HRS
Plate, Fixation, Bone
696
IYN
System, Imaging, Pulsed Doppler,...
632
GEI
Electrosurgical, Cutting &...
616
GEX
Powered Laser Surgical Instrument
528
JWH
Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
485
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Sulzermedica
Medical Device Manufacturer
·
US , Austin , TX
Sulzermedica - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1999
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sulzermedica
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667
·
DSY
Cardiovascular
·
88d
Cleared
Dec 09, 1999
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K990503
·
DSY
Cardiovascular
·
295d
Cleared
Nov 19, 1999
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832
·
DSY
Cardiovascular
·
88d
Filters
Filter by Specialty
All
5
Cardiovascular
3
Orthopedic
2