510k
Database
Specialties
Anesthesiology
484
Cardiovascular
1473
Chemistry
339
Dental
1160
Ear, Nose, Throat
216
Gastroenterology & Urology
851
General & Plastic Surgery
1926
General Hospital
1461
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
831
Obstetrics & Gynecology
367
Ophthalmic
248
Orthopedic
2531
Pathology
49
Physical Medicine
448
Radiology
2085
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
307
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
266
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
208
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
174
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Waters Assoc., Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Waters Assoc., Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1976
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Waters Assoc., Inc.
Toxicology
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 24, 1979
SYSTEM CONTROLLER 720 SERIES
K791661
·
KIE
Toxicology
·
34d
Cleared
Feb 15, 1979
CARTRIDGE HOLDER, RCM 100
K782175
·
KIE
Toxicology
·
49d
Cleared
Feb 15, 1979
SOLVENT DELIVERY SYSTEM
K790145
·
KIE
Toxicology
·
28d
Cleared
Jan 20, 1978
FLUORESCENCE DETECTOR MODEL 420
K780031
·
KHO
Toxicology
·
11d
Filters
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16
Cardiovascular
6
Toxicology
4
Chemistry
2
Radiology
2
General & Plastic Surgery
1
Anesthesiology
1