510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1672
Chemistry
362
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
967
General & Plastic Surgery
2190
General Hospital
2045
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2910
Pathology
52
Physical Medicine
515
Radiology
2433
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
219
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Biometer Intl. A/S
Medical Device Manufacturer
·
DK , Denmark
Biometer Intl. A/S - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1986
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biometer Intl. A/S
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
May 28, 1992
ELPHA 2000
K914231
·
IPF
Physical Medicine
·
251d
Cleared
Jun 16, 1989
AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL
K881196
·
IPF
Physical Medicine
·
452d
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9
Anesthesiology
7
Physical Medicine
2