510k
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Anesthesiology
525
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1614
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356
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1304
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237
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937
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2142
General Hospital
2013
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126
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91
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8
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458
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942
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429
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272
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2757
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52
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515
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2354
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Shanghai Draeger Medical Instrument Co., Ltd.
Medical Device Manufacturer
·
CN , Shanghai
Shanghai Draeger Medical Instrument Co., Ltd. - FDA 510(k) Cleared De...
3 submissions
·
3 cleared
·
Since 2025
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shanghai Draeger Medical Instrument Co., Ltd.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 24, 2026
Vista CMS
K250349
·
MHX
Cardiovascular
·
441d
Cleared
Apr 10, 2026
Vista 300/Vista 300 S
K252250
·
MHX
Cardiovascular
·
267d
Cleared
Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669
·
DSA
Cardiovascular
·
123d
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3
Cardiovascular
3