510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
237
Gastroenterology & Urology
933
General & Plastic Surgery
2142
General Hospital
1999
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2753
Pathology
52
Physical Medicine
515
Radiology
2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
374
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
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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Te ME NA S.A.R.L.
Medical Device Manufacturer
·
US , New Port Riche , FL
Te ME NA S.A.R.L. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1999
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Te ME NA S.A.R.L.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323
·
BXN
Anesthesiology
·
969d
Cleared
Jun 01, 2001
SPINAL EPIDURAL NEEDLES
K002405
·
BSP
Anesthesiology
·
298d
Cleared
Feb 21, 2001
TE ME NA EPIDURAL CATHETER
K991259
·
BSO
Anesthesiology
·
680d
Filters
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5
Anesthesiology
3
Neurology
1
General Hospital
1