BEUDAMED
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    BN PROSPEC SYSTEM

    FDA 510(k)
    FDA Class 1 ·Immunology

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001647·artVeneer life lower anteriors, UCL, BL4

    TensCare

    FDA UDI
    TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...

    Thuvera

    FDA UDI
    IPG Medical Corporation·00810071230073·Thuvera, Flat Tip, Reusable Laser Fiber, 150um

    DATEX-OHMEDA NETWORK AND CENTRAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·March 8, 2013

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LZO·February 22, 2011

    STRATA II VALVE, REGULAR, INTEGRAL SNAP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·February 18, 2008

    GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2023

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024