BEUDAMED
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    REPROCESSED ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040115586·Roth Brackets .022" UR3 HK -2T 13A 0O

    AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 45mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020977·

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70610451·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .01...

    ERA IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    Zimmer, Inc.·00889024186316·

    I-STAT ACT CELITE CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JBP·December 10, 2012

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2013

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·April 13, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 13, 2008

    UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal Medical Products, Lincoln, NE. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·December 6, 2011

    Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.

    FDA Recall
    Terminated ·Stanley Security Solutions, Inc.·Product code KMI·December 13, 2011

    M200 Fall Monitoring System

    FDA Recall
    Terminated ·Stanley Security Solutions Inc·Product code KMI·October 11, 2018

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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