BEUDAMED
    10,000 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 19, 2014

    FREEZOR MAX CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·September 2, 2015

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·September 2, 2015

    EVIS EXERA III COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·June 21, 2024

    FRONTIER ADVANCE CARDIAC SHEATH

    FDA Adverse Event
    Injury ·MDT ABLATION FRONTIERS MFG·Product code DRA·September 3, 2015

    UNK HIP FEMORAL STEM CORAIL

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code LZO·May 30, 2024

    STENT - VASCULAR RECONSTRUCTION

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·January 29, 2024

    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 Enforcement
    Class II ·Terminated·Ultradent Products, Inc.·June 27, 2012

    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

    KÖR DESENSITIZER

    FDA Adverse Event
    Injury ·EVOLVE DENTAL TECHNOLOGIES, INC.·Product code KLE·December 8, 2016

    ISODAN

    FDA Adverse Event
    Injury ·SEPTODONT·Product code KLE·November 21, 2016

    KÖR DESENSITIZER

    FDA Adverse Event
    Injury ·EVOLVE DENTAL TECHNOLOGIES, INC.·Product code KLE·November 1, 2016

    KOR TEETH DESENSITIZER

    FDA Adverse Event
    Injury ·EVOLVE DENTAL TECHNOLOGIES INC.·Product code KLE·July 30, 2015

    SCOTCHBOND UNIVERSAL

    FDA Adverse Event
    Injury ·3M DEUTSCHLAND GMBH·Product code KLE·September 24, 2015

    SCOTCHBOND UNIVERSAL ADHESIVE

    FDA Adverse Event
    Injury ·3M DEUTSCHLAND GMBH·Product code KLE·August 6, 2015

    GLUMA DESENSITIZER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH·Product code KLE·September 24, 2015

    SCOTCHBOND UNIVERSAL ADHESIVE

    FDA Adverse Event
    Injury ·3M DEUTSCHLAND GMBH·Product code KLE·September 30, 2015

    KOR TOOTH DESENSITIZER

    FDA Adverse Event
    Injury ·EVOLVE DENTAL TECHNOLOGIES INC.·Product code KLE·September 10, 2015

    SCOTCHBOND ETCHANT

    FDA Adverse Event
    Injury ·3M ESPE DENTAL PRODUCTS·Product code KLE·September 24, 2015

    KOR DESENSITIZER

    FDA Adverse Event
    Injury ·EVOLVE DENTAL TECHNOLOGIES INC.·Product code KLE·September 10, 2015