BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    ADJUSTABLE LARGE FIXATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeltaForm HD

    FDA UDI
    Merz Dental GmbH·D7091010344·Living mould chart DeltaForm HD in shade A3 con...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890103440·Zirlux 17 Degree Multi-Unit Abutment 3.5 mmH co...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100440·Assembly, Caddie, Locking Caps

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024090·Paddle Shaver, 14mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103140·Shaver, Closed, 14mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0100440·Caddie, Locking Caps

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    COSMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVIA IMS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    INSET I

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 7, 2025

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    GII

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·March 19, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 11, 2011

    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 Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021