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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    STRATO X

    FDA 510(k)
    FDA Class 2 ·Dental

    AirLife™

    FDA UDI
    AIRLIFE·10889483571057·AirLife™ Misty Max 10™ Nebulizer With Adult Aer...

    AirLife

    FDA UDI
    Carefusion Corporation·10885403039119·AirLife ™ Misty Max 10 ™ Nebulizer ...

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752114814·AirLife™ Misty Max 10™ Nebulizer With Adult Aer...

    SURGITEK GEL-FILLED IMPLANT

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994

    SURGITEK SILICONE IMPLANT

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994

    SURGITEK TEARDROP Q-S ADJUSTABLE BILUMEN IMPLANT

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994

    RESPONSE 2000 CEMENTED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZPower Rechargeable System for Hearing Aids

    FDA UDI
    ZPOWER, LLC·00850034007359·Charger for ZPower Rechargeable System for Hear...

    COMPR WIRE Ø2.8 L200/10

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWN·March 13, 2013

    OMNISPAN MENISCAL FASTENER; 12 DEGREE NEEDLE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MBI·January 28, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·August 12, 2014

    SYRINGE CONTROL 10ML LL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2020

    DELTA CER FM HD 032/-4.0 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·July 17, 2023

    BIOLOX DELTA LNR 32MM 50-52MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·July 17, 2023

    HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK

    FDA Adverse Event
    Malfunction ·Product code DSQ·October 19, 2021

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019