BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BD DIRECTIGEN EZ RSV KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER

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

    LIVESURE BARBITURATES SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MWI·September 9, 2010

    DINAMAP PROCARE SERIES MONITOR

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·September 9, 2010

    VERTE-STACK® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 7, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·March 26, 2013

    QUANTUM MAVERICK BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 17, 2011

    MELLCOR N-550 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code DQA·March 26, 2008

    VUELOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·January 22, 2025

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014