BEUDAMED
    17 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    QUICKVUE DIPSTICK STREP A

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QG-50-SE

    FDA UDI
    CARESTREAM HEALTH, INC.·60889974000429·QG-50-4 X-RAY SE GEN 50KW

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01109T0·Cervical Trial, 14 x 11, 9mm, 7 Degree, Tapered

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01109N0·Cervical Trial, 14 x 11, 9mm, 0 Degree, No Taper

    POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACTIVE ARRAY CATHETER, MODEL CS-2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    CM TITAMAX IMPLANT 4.0X7

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 5, 2018

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 19, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    REACT CATHETER

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code QJP·September 4, 2025

    TECA ELITE NEEDLE

    FDA Adverse Event
    Malfunction ·NATUS MANUFACTURING LTD·Product code IKT·December 14, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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