BEUDAMED
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    CHARTIS CATHETER MODEL CHR-CA-12.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189713·LEVAMED ACTIVE ANKLE SUP BLACK L II

    StaXx® XD System

    FDA UDI
    Spine Wave, Inc.·10840642100655·Cartridge Convex Expandable Implant 22x9x7mm

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033108·microSelectron Coupling Transfer Tube (20)

    DONJOY

    FDA UDI
    DJO, LLC·00888912006675·ICEMAN, ANKLE COLD PAD

    DEPUY PROSTHESIS

    FDA Adverse Event
    Injury ·DEPUY·Product code JDG·August 2, 1994

    RESORBABLE BONE PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRA SEAL STERILE LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514187·TPU,Side bend,11.5Fr,15cm working length with 2...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503515795·TPU,Straight,11.5Fr,15cm working length with 22...

    Biliary Plastic Stent Set

    FDA UDI
    Micro-Tech (Nanjing) Co., Ltd.·06932503514422·TPU,Center bend,11.5Fr,15cm working length with...

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·May 14, 2013

    DLT TS CER HD 12/14 36MM +5.0

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code LZO·September 23, 2014

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·June 2, 2011

    G2 FILTER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·April 16, 2020

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025