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

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    ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006540·3850AF PNT HTR CNTRL 230V 50HZ

    RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE

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

    LLX240AB01

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    G7 NEUTRAL E1 LINER 36MM E

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·August 13, 2018

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·May 14, 2013

    GLOBAL ADVANTAGE HUM HD 52X15

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWT·May 19, 2011

    HARMOINC ACE 23 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 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