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

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    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310020·Probe, 1.5 inch Ball, Steffee, Straight, Black

    SYNCHRON SYSTEMS OPIATE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00310021·

    ACRY FORM

    FDA UDI
    DENTAL MANUFACTURING SPA·08056865003122·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310030·Probe, 1.5 inch Ball, Steffee, Curved, Black

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380020·Handle, Ratcheting In Line Cannulated, Impact

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WAKO LIPASE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PLUM LS PRIM. 225 CM CLAVE PORT DISTA

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013

    BD VERITOR ¿ AT-HOME COVID-19 TEST

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·August 3, 2022

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·May 28, 2025

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 2, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011

    GE OEC 9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008

    TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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