BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037311929·REAMER Ø08 mm / HUDSON

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707045883·ADAMS CLASPS SIZE 8MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742112398·LYNX Olecranon Locking Plate, Anatomical, Ti - ...

    USS-LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    POWER CORD, TGS SYSTEM V2, 20' LG

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 8, 2019

    HEART START XL

    FDA Adverse Event
    Malfunction ·AGILENTTECHNOLOGIES, INC·Product code MKJ·March 20, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 10, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 15, 2011

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    TRINITY HIP OFFSET CUP IMPACTOR (CG)

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 24, 2015

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024