510k
Database
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551
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1730
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386
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1401
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258
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994
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2241
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2102
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127
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104
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8
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474
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986
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445
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286
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3082
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52
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517
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2511
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156
Categories
LZA
Polymer Patient Examination Glove
422
LLZ
System, Image Processing,...
401
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Powered Laser Surgical Instrument
366
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Mask, Surgical
361
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Electrosurgical, Cutting &...
313
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System, Imaging, Pulsed Doppler,...
305
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Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
234
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Maquet GmbH
Medical Device Manufacturer
·
DE , Rastatt
Maquet GmbH - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Maquet GmbH
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
May 18, 2022
GSS610N21 Series Steam Sterilizer
K214120
·
FLE
General Hospital
·
139d
Cleared
Mar 01, 2021
Getinge GSS610N Series Steam Sterilizer
K201927
·
FLE
General Hospital
·
234d
Cleared
Jan 30, 2018
Getinge GSS67N Series Steam Sterilizer
K172159
·
FLE
General Hospital
·
196d
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3
General Hospital
3