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

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    ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113642·LOCATOR R-Tx Abutment for 5.0mm Conelog Connect...

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607597·SKYTRON 6700, 6701 3" DELUXE GEL

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 7, 2023

    ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    KARL STORZ HYSTEROMAT II

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GEMSTAR SPLT SET Y-EXT W/ BACKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2013

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011

    EMAX2PLUS

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 1, 2015

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 27, 2014

    GEMSTAR 1.2 MICRON FLTR 244CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 2013

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·March 20, 2017

    Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PL VC I user interface has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of patient settings and for the display of alarm conditions. PL VC I provides the following types of ventilatory support: 1) Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure (CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure Support (PS). Available in SIMV and SPONT.

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·March 20, 2006

    Bivona Aire-Cuf Endotracheal Tube

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·November 3, 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