510k
Database
Specialties
Anesthesiology
545
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1699
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374
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1351
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250
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979
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2213
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2062
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126
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100
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8
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474
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980
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438
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282
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2988
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52
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515
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2468
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155
Categories
LZA
Polymer Patient Examination Glove
414
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System, Image Processing,...
398
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Powered Laser Surgical Instrument
363
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Mask, Surgical
358
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Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Sfm Medical Devices GmbH
Medical Device Manufacturer
·
DE , Waechtersbach
Sfm Medical Devices GmbH - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sfm Medical Devices GmbH
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 06, 2024
nextaro® va, 15mm, 5µm
K241976
·
LHI
General Hospital
·
63d
Cleared
Apr 16, 2024
nextaro® v, 20/20
K240748
·
LHI
General Hospital
·
28d
Cleared
Mar 15, 2019
nextaro Transfer System, nextaro va
K183187
·
LHI
General Hospital
·
116d
Filters
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3
General Hospital
3