BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·37613154184294·Bone Screws, Cross-Pin

    GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 42cm x 125°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014549·

    ACCU-CHEK ® GUIDE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·March 15, 2023

    PARACON II/FECAL CONCENTRATOR II

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHEMWELL, ALSO KNOWN AS PROJECT 2900

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 2, 2011

    INTERSTIM LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code EZW·April 2, 2008

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 22, 2023

    Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

    FDA Enforcement
    Class II ·Terminated·Asante Solutions, Inc.·January 8, 2014

    XP-XP Tibial Tray - Interlok 83 mm Item # 195759

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014