510k
Database
Specialties
Anesthesiology
486
Cardiovascular
1477
Chemistry
342
Dental
1165
Ear, Nose, Throat
216
Gastroenterology & Urology
856
General & Plastic Surgery
1935
General Hospital
1477
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
836
Obstetrics & Gynecology
369
Ophthalmic
250
Orthopedic
2548
Pathology
49
Physical Medicine
454
Radiology
2097
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
315
LLZ
System, Image Processing,...
308
LZA
Polymer Patient Examination Glove
286
GEI
Electrosurgical, Cutting &...
269
QIH
Automated Radiological Image...
259
HRS
Plate, Fixation, Bone
250
IYN
System, Imaging, Pulsed Doppler,...
248
OLO
Orthopedic Stereotaxic Instrument
209
NHA
Abutment, Implant, Dental,...
198
MAX
Intervertebral Fusion Device...
177
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Mahe-Medizintechnik
Medical Device Manufacturer
·
DE , Germany
Mahe-Medizintechnik - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1993
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mahe-Medizintechnik
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 02, 1994
MAHE INSTRUMENTS
K942821
·
GEI
General & Plastic Surgery
·
141d
Cleared
Aug 23, 1994
TROCAR WITH SHIELD
K942819
·
GCJ
General & Plastic Surgery
·
70d
Cleared
Mar 14, 1994
MAHE INSTRUMENTS
K935442
·
GCJ
General & Plastic Surgery
·
122d
Cleared
Jul 22, 1993
MICROSURGICAL INSTRUMENTS
K925624
·
GCJ
General & Plastic Surgery
·
258d
Filters
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8
General & Plastic Surgery
4
Obstetrics & Gynecology
2
Ear, Nose, Throat
1
Orthopedic
1