BEUDAMED
    23 results · 20ms · Sources: EU EUDAMED, US FDA

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    BHR MODULAR HEAD 46MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018

    SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    56MM AND R3 ACETABULAR SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694008235·2.4mm x 8mm Lag Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000758·2.4mm x 8mm Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694029124·2.4mm x 8mm Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035071·2.4 x 8mm Lag Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694060868·TAG, MMF SCREW, 8MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694054669·2.4mm x 8mm Screw Sterile Qty 5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694066808·HPS 2.4 x 8mm Lag Screw Sterile Qty 5

    CEREC VITABLOCKS MK2

    FDA 510(k)
    FDA Class 2 ·Dental

    AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    FCD-2

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL SPINE, INC.·Product code MRW·March 18, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 5, 2014

    2.4MM X 8MM SCREW

    FDA Adverse Event
    Injury ·OSTEOMED, LLC·Product code DZL·July 12, 2023

    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Unimed Surgical Products, Inc.·September 5, 2012

    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016AM -- Lot #: 062408-08, 062509-01. Product Usage: Intended for cutting and coagulation of soft tissue.

    FDA Recall
    Terminated ·Unimed Surgical Products, Inc.·Product code GEI·June 16, 2010

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015