510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1722
Chemistry
385
Dental
1379
Ear, Nose, Throat
252
Gastroenterology & Urology
985
General & Plastic Surgery
2224
General Hospital
2088
Hematology
127
Immunology
101
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8
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474
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983
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441
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283
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3050
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52
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515
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2497
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Medtech S.A.S
Medical Device Manufacturer
·
FR , Montpellier
Medtech S.A.S - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2010
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtech S.A.S
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 20, 2023
ROSA ONE Brain Application
K231103
·
HAW
Neurology
·
92d
Cleared
May 04, 2022
ROSA ONE Brain application
K214065
·
HAW
Neurology
·
128d
Cleared
Sep 23, 2010
ROSA SURGICAL DEVICE
K101791
·
HAW
Neurology
·
87d
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3
Neurology
3