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

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    Oxygen concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707112066·Pinnacle .022 MC UL 4/5 G/O -7T 0A 0O (10PK)

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010117·Pinnacle .022 MC UL 4/5 G/O -7T 0A 0O (10PK)

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113971·Votion .022 MC UL 4/5 G/O -7T 0A 0O (10PK)

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008282·Votion .022 MC UL 4/5 G/O -7T 0A 0O (10PK)

    M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·June 26, 2019

    BD LUER-LOK TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·May 10, 2019

    DENTAL ABUTMENT SCREW

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·October 27, 2022

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 15, 2011

    ZEPHYR XL SR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·July 3, 2019

    NEEDLE 26X3/8 IB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 23, 2019

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·April 3, 2019

    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018