8 results
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56ms
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Sources: EU EUDAMED, US FDA
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·November 1, 2011
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 22, 2012
EASYPUMP® II
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code MEB·November 7, 2016
DELTAMAXX - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·April 9, 2015
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 29, 2011
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code KLE·May 24, 2012
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
FDA Recall
Open, Classified
·Genicon, Inc.·Product code N/A·August 25, 2020
Lotus NL B.V.
Authorized representative
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