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

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    Magic UCLA Abutment System

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)

    RR - UP - Commuter Passenger - zlb

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb

    REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 17, 2008

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 4, 2011

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023

    10MM/125 DEG TI CANN TFNA 420MM/RIGHT - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·May 3, 2018

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 27, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 12, 2024

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 5, 2024

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025