510k
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305
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175
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1570
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112
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2213
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1798
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Powered Laser Surgical Instrument
258
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248
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236
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222
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219
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217
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182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
146
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Carl Zeiss Surgical GmbH
Medical Device Manufacturer
·
US , North Attleboro , MA
Carl Zeiss Surgical GmbH - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2005
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carl Zeiss Surgical GmbH
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 13, 2012
INTRABEAM NEEDLE APPLICATOR
K110590
·
JAD
Radiology
·
408d
Cleared
Mar 03, 2010
ZEISS INFRARED 800 WITH FLOW 800 OPTION
K100468
·
IZI
Radiology
·
13d
Cleared
Nov 24, 2009
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
K090584
·
JAD
Radiology
·
266d
Cleared
May 23, 2005
INTRABEAM SYSTEM
K051055
·
JAD
Radiology
·
27d
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4
Radiology
4