BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768475·GENUMEDI PSS GREEN III

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000417·MCK Patellofemoral Component

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896000315·FUKUSHIMA SUCTION TUBE

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991804030·FUKUSHIMA SUCTION TUBE

    N/A

    FDA UDI
    Ortho Development Corporation·00822409128914·4-in-1 Cut Guide w/ Anterior Lip Size 3

    Fixed Distal Varus Guide

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215063740·

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    XTJF TYPE Q160VF1

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

    MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 1, 2008

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 27, 2011

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022