BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679931·SPACER 5001232 CONTROL PTC 6 DEG 12X32

    Endo-Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964010352·Endo Carry-on Procedur Kit contains all of the ...

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169109773·SPACER 4001232 6 DEG 12X32

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001232·artVeneer life upper anteriors, CM, B3

    Isolaz

    FDA UDI
    SOLTA MEDICAL·00816995020523·MD ISR ST I-IV 600

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.·Product code MOM·March 12, 2024

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962161500·LABRAL SUTURE ANCHOR DRILL, 3.2MM

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·February 23, 2026

    BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 13, 2013

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·February 24, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·February 22, 2008

    108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2015

    Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4

    FDA Recall
    Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

    Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3

    FDA Recall
    Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018