510k
Database
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Anesthesiology
506
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1577
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355
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1263
Ear, Nose, Throat
233
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911
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2093
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1774
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126
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91
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8
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445
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916
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417
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265
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2672
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49
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502
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2278
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154
Categories
LZA
Polymer Patient Examination Glove
355
LLZ
System, Image Processing,...
348
GEX
Powered Laser Surgical Instrument
346
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Electrosurgical, Cutting &...
290
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Automated Radiological Image...
272
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System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
232
OLO
Orthopedic Stereotaxic Instrument
217
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Abutment, Implant, Dental,...
204
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Automedx, Inc.
Medical Device Manufacturer
·
US , Germantown , MD
Automedx, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2007
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Automedx, Inc.
Anesthesiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 21, 2014
SAVE II, SAVE II BASIC
K131877
·
BTL
Anesthesiology
·
269d
Cleared
Sep 06, 2007
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
K071221
·
BTL
Anesthesiology
·
127d
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Anesthesiology
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