9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3 CCD ENDOCAM 5550
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608709·MAQUET 4.25" SOFTCARE PLUS
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 21, 2016
8CM HEAVY DUTY MEDIUM ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 24, 2013
NEXGEN LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code JWH·April 13, 2011
ORTHO PROVUE
FDA Adverse Event
Other
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·July 24, 2008
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015