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

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    ROYAL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·10842209112934·

    SCANLAN® V.I.P™ Instrument Sterilization Trays

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159010961·Sterilization/Storage Case

    Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROFEMUR HIP SYSTEM MODULAR NECKS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 8, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·November 15, 2012

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia

    FDA Recall
    Terminated ·Epimed International, Inc.·Product code BSO·June 18, 2019

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

    FDA Recall
    Terminated ·Epimed International, Inc.·Product code BSO·June 18, 2019

    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.

    FDA Recall
    Terminated ·Accuro Medical Product LLC·Product code OMP·August 31, 2012

    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 20, 2020

    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 20, 2020

    IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FPA·March 1, 2011

    Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FPA·March 1, 2011

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021