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    ISOLA POLYAXIAL WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMBINATION GEL-INFLATABLE MAMMARY PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN HEYER-SCHULTE·Product code FTR·May 5, 1998

    SIMPLY SPECS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033493649·

    SIMPLY SPECS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033493632·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    SIMPLY SPECS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033493625·

    CASTLE MODEL 233HC STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FREELITE KAPPA FREE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    0009613348-2024-013441

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·October 8, 2024

    3.5 MM CORTICAL SCREW SELF-TAPPING 24 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·March 29, 2019

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 20, 2013

    M SERIES BIPHASIC

    FDA Adverse Event
    Injury ·ZOLL·Product code MKJ·March 4, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022