BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271001·

    XIPHOS ZFUZE

    FDA UDI
    Difusion Technologies, Inc.·00853896008366·TLIF Spacer 27mm Long x 10mm Height

    N/A

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327551938·Flat Disc Stick-On Fiducials

    N/A

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327545913·Spine Guidance Enable

    N/A

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327545883·Spine Guidance Software

    MINIMED MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·September 15, 2025

    MD 10, SEM, SM 12, CBM

    FDA 510(k)
    FDA Class 1 ·Dental

    STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 13, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·February 26, 2008

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORP.·Product code FDT·July 24, 2015

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024