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

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    STERILE VINYL EXAMINATION GLOVES, Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003715·MCK BASEPLATE TRIAL (SIZE 2 RM/LL)

    n/a

    FDA UDI
    Ortho Development Corporation·00822409091713·Diamond Tooth Broaches Size 12

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107507·TRIAL 90-SRK-170612 POLY UCCS 6X12MM

    FM20

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

    TOP-RANK ADHESIVE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·October 19, 2022

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 14, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 24, 2008

    Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514 j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610 k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612 l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·March 27, 2018

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·May 14, 2018

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·December 4, 2018

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·November 5, 2018

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·October 29, 2018

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·October 2, 2018

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·November 12, 2018

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·November 15, 2018

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code OQY·November 27, 2018