510k
Database
Specialties
Anesthesiology
529
Cardiovascular
1640
Chemistry
359
Dental
1308
Ear, Nose, Throat
239
Gastroenterology & Urology
947
General & Plastic Surgery
2163
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
459
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2798
Pathology
52
Physical Medicine
515
Radiology
2375
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
377
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
222
NHA
Abutment, Implant, Dental,...
205
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Fresenius USA, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Fresenius USA, Inc. - FDA 510(k) Cleared Devices
38 submissions
·
37 cleared
·
Since 1984
38
Total
37
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fresenius USA, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042
·
JGS
Chemistry
·
147d
Cleared
Jul 19, 1990
IONOMETER EH-F AND ACCESSORIES
K901040
·
JGS
Chemistry
·
135d
Cleared
Jun 28, 1990
IONOMETER EH
K901039
·
CEM
Chemistry
·
114d
Cleared
Jun 18, 1990
IONOMETER EH-HK AND ACCESSORIES
K901041
·
CEM
Chemistry
·
104d
Filters
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All
38
Gastroenterology & Urology
28
Chemistry
4
Cardiovascular
3
Dental
2
Anesthesiology
1