BEUDAMED
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    KIM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Redicare

    FDA UDI
    REDICARE LLC·B70901030221·50 Fabric Small Patch Junior Strip Bandages Lat...

    MMF AXS

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327581799·AXS Tension Pliers, MMF, spare

    ALL SILICONE FOLEY BALLOON CATHETER

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369403061·3way//Translucent 5cc 22fr

    Mariner Deformity

    FDA UDI
    Seaspine Orthopedics Corporation·10889981293222·CD Tip, Lordotic, Right

    S7 / OPMI Sensera

    FDA UDI
    Carl Zeiss Meditec AG·04049539104168·

    S7 / OPMI PROergo

    FDA UDI
    Carl Zeiss Meditec AG·04049539104106·

    DULBECCO'S PHOSPHATE BUFFERED SALINE NO.210-3022

    FDA 510(k)
    FDA Class 1 ·Hematology

    NA

    FDA UDI
    aap Implantate AG·04042409049163·K-wire with thread and trocar point, ø3.0, L 220

    SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AERONEB PORTABLE NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 6, 2025

    NA

    FDA UDI
    aap Implantate AG·04042409049170·K-wire with thread and trocar point, ø3.0, L 220

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL INC.·Product code HSX·May 15, 2014

    HFN LH 130 DEG 11MM X 380MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·January 6, 2021

    1.5X4MM HT SD X-DR SCR, EA

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·May 9, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code ILS·September 19, 2014

    20/20 PRIORITY PACK W/COPILOT

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DTL·May 25, 2011

    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 10, 2021

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021