BEUDAMED
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    NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942431519·ULTRASOUND TRAY DEPT XRAY

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010030436·HALF RING 110MM COMPOSITE

    Tasso+

    FDA UDI
    Tasso Inc.·00850038691004·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450263785·

    Indus

    FDA UDI
    SPINEFRONTIER, INC.·00190361035572·Indus Invue MAX Symmetrical ACP, 2 Level, 51mm

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161013510·Curved Broach Handle

    AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEUROSCOUT STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA? 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 15, 2026

    CONTOURED CROSSBAR LARGE 3.5 ROD

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code KWP·May 3, 2013

    UNKNOWN DEPUY PINNACLE ACETABULAR SHELL

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2011

    ABSOLUTE.035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code FGE·December 13, 2006

    ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020

    ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018