BEUDAMED
    32 results · 21ms · Sources: EU EUDAMED, US FDA

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    Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Phasix

    FDA UDI
    Davol Inc.·00801741107511·Phasix Mesh, 4.5" (11 cm), Circle

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694089432·11mm, OsteoFlap

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694005500·11mm, OsteoFlap, Sterile

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100110·Tray Insert, Rod Connectors

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100110·Tray Insert 4, Cosmolock, Arcamed

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

    HEISENBERG EFFECT SHADES

    FDA 510(k)
    FDA Class 2 ·Dental

    FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·LIAISON XL MUREX HCV Ab

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·LIAISON XL MUREX HCV Ab

    NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT

    FDA Adverse Event
    Malfunction ·Product code BZE·March 3, 2021

    BUBBLE CPAP CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 8, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 3, 2011

    BUBBLE CPAP CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011

    Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    BUBBLE CPAP GENERATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·February 16, 2017