BEUDAMED
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    BIOANCHOR WITH DISPOSABLE DRIVER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033804·Baltic Denture System BDLoad BDLoad Mm7 PLSEbi...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

    SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOCRATES ROBOTIC TELEMONITORING SYSTEM

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

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NQP·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED REL·Product code MDS·March 17, 2011

    UNKNOWN SUTURE PRODUCT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAO·April 24, 2008

    EMBRYO RPLCMNT CATHETER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

    Hill-Rom brand Century+ bed; model P1400.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code FNL·December 26, 2003

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024