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

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    Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nex-Link®

    FDA UDI
    ZIMMER SPINE, INC.·00889024332102·

    Olecranon Hook Plate, Locking

    FDA UDI
    I.T.S. GmbH·09120047296998·Olecranon Hook Plate, Locking, 7-Hole, left

    Stryker

    FDA UDI
    Provision·B504OM42111270750·

    Sage Cervical Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C20412111270·PEEK Cervical Spacer, 12 x 11 x 12mm, 7 deg

    Sage Cervical Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C21412111270·Titanium Cervical Spacer, 12 x 11 x 12mm, 7 deg

    NA

    FDA UDI
    STERILMED, INC.·10888551030809·SAW BLADE DUAL CUT

    NA

    FDA UDI
    STRYKER CORPORATION·04546540967725·Dual Cut Sagittal Blade, Flared

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825014759·Dual Cut Saw Blade

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 29, 2002

    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS

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

    NOVUM IQ

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025

    RECOVERY FILTER SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 23, 2008

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 8, 2011

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·July 8, 2013

    Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007

    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·January 12, 2022