BEUDAMED
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    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450266083·

    Spectraline™ 20mL Syringe

    FDA UDI
    Merit Medical Systems, Inc.·00884450270882·

    Prima

    FDA UDI
    KEYSTONE DENTAL, INC.·D7680010787000·Ti Base

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238004·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238011·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238035·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033238028·

    XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUART ARTERIAL FILTER, MODEL HBF 140

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 24, 2022

    OPTETRAK THREE PEG PATELLA 38MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 4, 2024

    PLASMABLADE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code DWG·March 19, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 8, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 16, 2023

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 3, 2025

    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter, 007768; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 010579; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 010580; MICROSTREAM VitaLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for High Ambient Humidity X25, 010787; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 015016; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 015021; MICROSTREAM FilterLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, XS04620; MICROSTREAM FilterLine H Set Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, XS04624.

    FDA Recall
    Open, Classified ·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code CCK·February 17, 2025

    Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530

    FDA Recall
    Terminated ·Oridion Medical·Product code CCK·February 16, 2012