510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1340
Chemistry
331
Dental
1035
Ear, Nose, Throat
192
Gastroenterology & Urology
795
General & Plastic Surgery
1756
General Hospital
1163
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
204
Orthopedic
2398
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44
Physical Medicine
400
Radiology
1939
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
286
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
233
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
188
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Mondeal Medical Systems GmbH
Medical Device Manufacturer
·
NL , Amsterdam
Mondeal Medical Systems GmbH - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2005
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mondeal Medical Systems GmbH
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 19, 2007
MONDEAL EXTREMITY BONE FIXATION SYSTEM
K072740
·
HRS
Orthopedic
·
53d
Cleared
Sep 17, 2007
MONDEAL HAND CONTOUR SYSTEM
K071797
·
HRS
Orthopedic
·
77d
Cleared
Sep 17, 2007
MONDEAL DISTAL RADIUS SYSTEM
K071798
·
HRS
Orthopedic
·
77d
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6
Dental
3
Orthopedic
3