BEUDAMED
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    ENDO-EASE ENDOSCOPIC OVERTUBE

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

    Mini-Mono® Brackets

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602351·Mini-Mono-Brackets Andrews 'N' .018" 100 Bracke...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

    SETROX S 45

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·November 29, 2006

    PHILOS DR

    FDA Adverse Event
    BIOTRONIK GMBH AND CO.·Product code DTB·November 29, 2006

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867523340·DILATOR, 6.0 X 235MM

    TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 16, 2013

    OMNI-FLOW MODEL 4000 PLUS

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FRN·June 12, 2008

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2011

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001511;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013