BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    VALO Grand Corded and Accessory Lenses

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885556009215·TWIST DRILL W/SUTURE HOLE 2.4MMX127MM

    Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Clear

    FDA UDI
    DIAGAST·23661562105506·Anti-Human Globulin Anti-IgG,-C3d (Murine Monoc...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108462·5 MM DIA., 45 CM INSULATED SPATULA TIP ELECTROD...

    Zodiac

    FDA UDI
    ALPHATEC SPINE, INC.·00844856003330·TI 5.5MM TELESCOPING BRIDGE, 50MM

    COMPREHENSIVE REVERSE SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018

    Inertia® Pedicle Screw and Deformity Correxxion® System

    FDA UDI
    NEXXT SPINE, LLC·00889929027257·MAC Pedicle Screw, Ø10.5x50 mm

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68169102105500·5.5mm Cannulated Screw Kit

    BRIGHT EMBRACE MODEL SBL60

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

    FDA 510(k)
    FDA Class 2 ·Immunology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 27, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWB·October 22, 2008

    UNIFY ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 3, 2018

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    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

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025