BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604250·Tray, Base, 4.25"

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197541350·RZ Tebbet Breast Retractor 80x25m...

    EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAVEWRITER ALPHA? PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 4, 2025

    GMK-PRIMARY TIBIAL INSERT FIXED SIZE 3 / 17 MM STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2017

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 4, 2015

    TENACULUM FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·March 29, 2013

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·April 26, 2013

    OCTRODE TRAIL LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011

    TRIDENT PSL HA SOLID BACK 62MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·July 21, 2008

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 26, 2013

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 17, 2017

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LIT·May 23, 2016

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018