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

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    ELECSYS DHEA-S CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110501·DURA-CUF, INFANT, 1 TB SCREW, 08 - 13 CM, SINGLE

    3D

    FDA UDI
    Rmo, Inc.·00885797100153·3D LING ARCH ASST 30

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123680·Yasargil Bipolar Forcep

    REACH FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RADIOLUCENT COLLES FRACTURE KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 3, 2021

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·October 14, 2024

    ION¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 13, 2013

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FDI·February 28, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 26, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 22, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 22, 2024

    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

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018