510k
Database
Specialties
Anesthesiology
485
Cardiovascular
1476
Chemistry
341
Dental
1162
Ear, Nose, Throat
216
Gastroenterology & Urology
854
General & Plastic Surgery
1931
General Hospital
1469
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
834
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2544
Pathology
49
Physical Medicine
454
Radiology
2091
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
314
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
285
GEI
Electrosurgical, Cutting &...
268
QIH
Automated Radiological Image...
258
HRS
Plate, Fixation, Bone
249
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
176
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Baumer Ortopedia , Ltd.
Medical Device Manufacturer
·
BR , Mogi Mirim-Sp-Brasil
Baumer Ortopedia , Ltd. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1994
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baumer Ortopedia , Ltd.
Orthopedic
✕
5
devices
1-5 of 5
Filters
Cleared
Apr 25, 1994
BAUMER PLATES
K930966
·
HRS
Orthopedic
·
425d
Cleared
Mar 29, 1994
BAUMER PINS
K930969
·
HTY
Orthopedic
·
398d
Cleared
Mar 29, 1994
INTRAMEDULLARY SYSTEMS
K930972
·
HSB
Orthopedic
·
398d
Cleared
Mar 07, 1994
BAUMER STAPLES
K930967
·
JDR
Orthopedic
·
376d
Cleared
Jan 07, 1994
BAUMER SCREWS
K930970
·
HWC
Orthopedic
·
317d
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Orthopedic
5