510k
Database
Specialties
Anesthesiology
144
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586
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167
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329
Ear, Nose, Throat
68
Gastroenterology & Urology
297
General & Plastic Surgery
543
General Hospital
387
Hematology
67
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58
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0
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236
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176
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70
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53
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1309
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19
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93
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891
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
138
OLO
Orthopedic Stereotaxic Instrument
118
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Htl Strefa SA
Medical Device Manufacturer
·
PL , Ozork?w
Htl Strefa SA - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) cleared devices by Htl Strefa SA
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 07, 2022
DropSafe Safety Pen Needles
K211716
·
FMI
General Hospital
·
218d
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General Hospital
1