510k
Database
Specialties
Anesthesiology
524
Cardiovascular
1611
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2135
General Hospital
1988
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
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941
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427
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272
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2701
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52
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514
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2319
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
FXX
Mask, Surgical
354
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Alaris Medical Systems, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Alaris Medical Systems, Inc. - FDA 510(k) Cleared Devices
16 submissions
·
16 cleared
·
Since 1998
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alaris Medical Systems, Inc.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 09, 2004
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741
·
CCK
Anesthesiology
·
250d
Cleared
Sep 11, 2002
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
K022677
·
DQA
Anesthesiology
·
30d
Cleared
Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966
·
DQA
Anesthesiology
·
67d
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16
General Hospital
11
Anesthesiology
3
Neurology
1
Cardiovascular
1