510k
Database
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Anesthesiology
456
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1389
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334
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1080
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198
Gastroenterology & Urology
825
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1821
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1271
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124
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85
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7
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420
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778
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345
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218
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2439
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46
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416
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2008
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143
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GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
291
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Electrosurgical, Cutting &...
256
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Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
242
HRS
Plate, Fixation, Bone
240
LZA
Polymer Patient Examination Glove
217
OLO
Orthopedic Stereotaxic Instrument
199
NHA
Abutment, Implant, Dental,...
189
MAX
Intervertebral Fusion Device...
169
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Heraeus Kulzer GmbH & Co. KG
Medical Device Manufacturer
·
DE , Hanau
Heraeus Kulzer GmbH & Co. KG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2003
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heraeus Kulzer GmbH & Co. KG
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
May 25, 2004
REFOBACIN -PALACOS G
K031673
·
LOD
Orthopedic
·
361d
Cleared
Sep 23, 2003
PALACOS R
K030902
·
LOD
Orthopedic
·
183d
Cleared
Sep 23, 2003
OSTEOPAL
K030903
·
LOD
Orthopedic
·
183d
Cleared
Feb 26, 2003
PALABOND
K022251
·
LOD
Orthopedic
·
229d
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Orthopedic
4