510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1681
Chemistry
368
Dental
1339
Ear, Nose, Throat
249
Gastroenterology & Urology
977
General & Plastic Surgery
2196
General Hospital
2048
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
436
Ophthalmic
279
Orthopedic
2943
Pathology
52
Physical Medicine
515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
279
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Novatech SA
Medical Device Manufacturer
·
FR , La Ciotat Cedex
Novatech SA - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 1997
5
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Novatech SA
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 13, 2017
NOVATECH TALCAIR
K170030
·
GCJ
General & Plastic Surgery
·
68d
Cleared
Mar 31, 2016
NOVATECH TALCAIR
K151832
·
GCJ
General & Plastic Surgery
·
269d
Cleared
Aug 21, 1997
ENDOXANE
K971509
·
NWA
General & Plastic Surgery
·
118d
Filters
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5
General & Plastic Surgery
3
Ear, Nose, Throat
1
Anesthesiology
1