BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    EASTLYTE NA/K/CA/PH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    8200 VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00817136020082·8276C INF/BAL VLV LESS HCNTRL

    TORNIER BIOFIBER SCAFFOLD

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

    VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 15, 2025

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·May 14, 2013

    UNKNOWN DEPUY TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 18, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 12, 2008

    MYSPINE STANDARD DRILL GUIDE T07

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023

    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 17, 2012

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

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

    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