510k
Database
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Anesthesiology
452
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1372
Chemistry
334
Dental
1064
Ear, Nose, Throat
195
Gastroenterology & Urology
814
General & Plastic Surgery
1792
General Hospital
1227
Hematology
121
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85
Medical Genetics
7
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420
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768
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338
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215
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2429
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44
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411
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1984
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143
Categories
GEX
Powered Laser Surgical Instrument
293
LLZ
System, Image Processing,...
285
GEI
Electrosurgical, Cutting &...
254
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Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
207
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Daum GmbH
Medical Device Manufacturer
·
US , Crofton , MD
Daum GmbH - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1997
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Daum GmbH
Gastroenterology & Urology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037
·
KNW
Gastroenterology & Urology
·
77d
Cleared
Jun 25, 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
K991366
·
KNW
Gastroenterology & Urology
·
66d
Cleared
Apr 28, 1999
DAUM NEUROGATE TROCAR
K990782
·
KNW
Gastroenterology & Urology
·
50d
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4
Gastroenterology & Urology
3
Radiology
1