510k
Database
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Anesthesiology
510
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1584
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355
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1274
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233
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922
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2109
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1856
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126
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91
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8
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449
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926
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420
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266
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2678
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50
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506
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2290
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154
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LZA
Polymer Patient Examination Glove
381
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System, Image Processing,...
356
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Powered Laser Surgical Instrument
347
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Electrosurgical, Cutting &...
292
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Automated Radiological Image...
272
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Mask, Surgical
270
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System, Imaging, Pulsed Doppler,...
263
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Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
Medical Device Manufacturer
·
US , Laurel , MD
Ohmeda Medical, A Division of Datex-Ohmeda, Inc. - FDA 510(k) Cleared...
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 31, 2015
Giraffe Incubator Carestation CS1
K152809
·
FMZ
General Hospital
·
94d
Cleared
Oct 02, 2012
GIRAFFE AND PANDA WARMERS
K122267
·
FMT
General Hospital
·
64d
Cleared
Jul 21, 2010
GIRAFFE AND PANDA WARMERS
K101804
·
FMT
General Hospital
·
23d
Filters
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3
General Hospital
3