510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
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963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Bemer Int AG
Medical Device Manufacturer
·
LI , Triesen
Bemer Int AG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bemer Int AG
Physical Medicine
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 09, 2023
Bemer Therapy System Evo
K231368
·
NGX
Physical Medicine
·
29d
Cleared
Feb 04, 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174
·
NGX
Physical Medicine
·
13d
Cleared
Feb 22, 2017
BEMER Classic Set, BEMER Pro-Set
K151834
·
NGX
Physical Medicine
·
597d
Filters
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4
Physical Medicine
3
General & Plastic Surgery
1