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

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    MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964066603·The ENDO CARRY-ON Procedure Kit contains all of...

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989027556·COPPER NITI 40 BAF17X25UP LG PK10

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450025789·

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 19, 2014

    HARMONIC

    FDA Adverse Event
    ETHICON ENDO-SURGERY, INC.·Product code LFL·May 20, 2011

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 18, 2016

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

    5.5MM TI CURVED ROD 45MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015