8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACETONE ALCOHOL PREP PAD
FDA 510(k)
FDA Unclassified
·Unknown
COBAS INTEGRA ALP IFCC GEN.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)
FDA 510(k)
FDA Class 2
·Radiology
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·November 15, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 9, 2010
FLEX ARM
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·February 8, 2018
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 2, 2018