BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Ultrasonic Scaler Tips

    FDA 510(k)
    FDA Class 2 ·Dental

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925018280·WOLF INSTRUMENT ADAPTOR

    FLEXCERA BASE

    FDA Adverse Event
    Malfunction ·ENVISIONTEC GMBH·Product code EBI·November 10, 2021

    BD VACUTAINER® URINE COLLECTION CUP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code KDT·April 6, 2022

    LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTEC LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 12, 2024

    ARIS TRANS-OBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTN·November 6, 2019

    FG 6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 1, 2011

    TOTAL ASR ACET IMP SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 16, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021