510k
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Anesthesiology
467
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1405
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334
Dental
1101
Ear, Nose, Throat
203
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828
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1846
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1319
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124
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86
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351
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224
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2452
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47
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421
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2025
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144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
232
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Heraeus Kulzer, Inc., Dental Products Division
Medical Device Manufacturer
·
US , South Bend , IN
Heraeus Kulzer, Inc., Dental Products Division - FDA 510(k) Cleared D...
1 submissions
·
1 cleared
·
Since 2008
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heraeus Kulzer, Inc., Dental Products Division
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 05, 2008
FLEXITIME BITE
K082591
·
ELW
Dental
·
88d
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