BEUDAMED
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    RHIGENE MESACUP2 TEST- RNP

    FDA 510(k)
    FDA Class 2 ·Immunology

    PowerMidline

    FDA UDI
    Bard Access Systems, Inc.·00801741141959·Catheter Placement Kit

    TruLock

    FDA UDI
    Rmo, Inc.·00885797644909·TRULOCK Light Activated Adhesive Mini Kit (1ea ...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099570·MAX 1ST MOLAR LEFT 92 BANDS

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·July 11, 2024

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·September 25, 2024

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

    FDA 510(k)
    FDA Class 1 ·Radiology

    KIPPMED I.V. MANIFOLD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

    DISSECTOR CEV531-3 DIA 5MM LRG CVD

    FDA Adverse Event
    Injury ·INTEGRA MICROFRANCE S.A.S.·Product code GEI·June 7, 2019

    SELOX JT 45

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 12, 2013

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION PULSE GENERATOR·Product code LGW·February 17, 2011

    KINSA SUTURE ANCHOR SYSTEM, MACHINED PEEK

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code MBI·February 19, 2008

    IMP,TSV,4.7,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 14, 2022

    BIFURCATED EXT SET

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code FPA·August 19, 2020

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 2012

    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