BEUDAMED
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    MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741136801·Catheter Placement Kit

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282505592·TeWa PB-Type 2030: coated acupuncture needles ...

    CORTEK CYSTOSCOPE

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

    GSI 2000 MIDDLE EAR ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PENUMBRA ASPIRATION PUMP CANISTER

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code JCX·December 8, 2010

    PROXIMATE RELOADABLE LINEAR STAPLER

    FDA Adverse Event
    Injury ·*·Product code GAG·October 23, 1997

    PROXIMATE RELOADABLE LINEAR STAPLER

    FDA Adverse Event
    Injury ·*·Product code GAG·October 23, 1997

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·March 12, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 24, 2011

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 15, 2008

    ZUMA Z2 7F GUIDE CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC·Product code DQY·June 12, 2020

    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

    FDA Enforcement
    Class II ·Ongoing·Preat Corp·June 25, 2025

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017

    BrightView SPECT, Model Number 882480

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    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