BEUDAMED
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    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040118082·Sponge Non-Woven Cotton NS

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964009844·The ENDO CARRY-ON Procedure Kit contains all of...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001090·artVeneer life lower anteriors, UBL, A3

    Epredia

    FDA UDI
    RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214612·Cassettes are designed to contain incised tissu...

    AOS CAPTURED CORTICAL SCREW 5.0mm x 90mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019285·

    NOBELACTIVE INTERNAL RP 4.3X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 25, 2024

    NOBELACTIVE INTERNAL RP 4.3X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 25, 2024

    MODIFICATION TO CARTO EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 6, 2017

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·March 5, 2013

    COULTER® HMX AUTOLOADER ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·February 24, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·February 22, 2008

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 26, 2019

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·November 4, 2015

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025