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

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    DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT

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

    TOWEL DRAPE, MODELS 4409, 4410

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SOLAR SPO2 MODULE WITH MASIMO SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75 X 14MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016

    PINN CAN BONE SCREW 6.5MMX30MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·April 9, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    CONTAK RENEWAL 2

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67X14MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016

    VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 28, 2017

    VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·February 6, 2017

    VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·October 31, 2017

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 2, 2017

    VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 13, 2016

    VANGUARD DA 360 TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 27, 2017

    VANGUARD SSKPSC TIBIAL BEARING S 12X63/67

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017

    VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017

    PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024