510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1418
Chemistry
334
Dental
1119
Ear, Nose, Throat
209
Gastroenterology & Urology
836
General & Plastic Surgery
1876
General Hospital
1386
Hematology
125
Immunology
87
Medical Genetics
8
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424
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808
Obstetrics & Gynecology
355
Ophthalmic
234
Orthopedic
2468
Pathology
48
Physical Medicine
429
Radiology
2049
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
GEI
Electrosurgical, Cutting &...
259
LZA
Polymer Patient Examination Glove
257
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Rotec Medizintechnik GmbH
Medical Device Manufacturer
·
DE , Weisendorf
Rotec Medizintechnik GmbH - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2000
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Rotec Medizintechnik GmbH
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 18, 2000
MRS-TITAN
K992359
·
LZO
Orthopedic
·
219d
Cleared
Jan 21, 2000
MRP-TITAN
K992403
·
LZO
Orthopedic
·
186d
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Orthopedic
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