BEUDAMED
    22 results · 32ms · Sources: EU EUDAMED, US FDA

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    Patient Positioning System

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207054116·INSUFFLATION TUBE SET L 3M high-flow with heat...

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003470·MCK FEMORAL TRIAL (SIZE 2 LM/RL)

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018643·CALIBRA 1ST MOLAR BANDS n.LL 2

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481122026·LOCATOR F-Tx Abutment For 6.0mm Platform Extern...

    ASCENSION TOTAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RADIUS SNARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    25 GA POSTERIOR WIDE-FIELD ELITE PACK

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

    8CM ANGLE ATTACHMENT, BLACK MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 14, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 21, 2011

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    T-HANDLE INSERTER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 20, 2018

    T-HANDLE

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023

    IMPLANT INSERTER SH CONNECTION

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·May 8, 2019

    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 20, 2016

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Recall
    Terminated ·Bard Medical Division·Product code DWJ·November 8, 2017