BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

    FDA 510(k)
    FDA Class 2 ·Dental

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551076927·Scissors, straight, 12.5 cm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776382124·Dedo Table Mounted Tray Bed Post

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111174797·METZ LAHEY SCISS DEL CVD 4 1/2

    Medical disposable face mask non sterile

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX MEDICAL CPAP RT 21XX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·November 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    ROTALINK? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·July 12, 2013

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 22, 2018

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 22, 2018

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·July 22, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 23, 2026

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 16, 2026

    BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.

    FDA Enforcement
    Class II ·Terminated·OPTI Medical Systems, Inc·October 3, 2012

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024