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

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    Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII

    AGXO

    FDA UDI
    Oticon A/S·05707131286857·H100V2, MINIRITE 312 WL CBE AGXO

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·September 10, 2019

    OPTIBOND SE

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 25, 2024

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·November 9, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 7, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 30, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011

    UNKNOWN KNEE PATELLA

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 21, 2019

    UNKNOWN KNEE FEMORAL

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 21, 2019

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024