510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1681
Chemistry
368
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
977
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2943
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Waters Instruments, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Waters Instruments, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 1981
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Waters Instruments, Inc.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 23, 1992
OXICOM-2100
K921519
·
DQA
Anesthesiology
·
206d
Cleared
Aug 26, 1991
OXICOMPLUS
K911207
·
DQA
Anesthesiology
·
160d
Cleared
Aug 18, 1986
OSC-80 OXIMETER
K862161
·
DQA
Anesthesiology
·
73d
Cleared
Nov 14, 1985
MVP - 6000
K852909
·
BZC
Anesthesiology
·
128d
Filters
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All
12
Gastroenterology & Urology
5
Anesthesiology
4
Cardiovascular
3