BEUDAMED
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    BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040151501·ZIRLUX ACETAL MILLING DISC

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010080479·GOUGE COMPOUND CURVE

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033440414·

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0120020·Driver Shaft, Final Tighten

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120020·T-Handle, T25, Screw Height Adjuster

    XUB EXTERNAL ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NEUROTOLOGY DRAPE, MODEL TBD

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

    GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2023

    NAIL HANDLE T2 TIBIA

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

    TROCAR, LONG T2 FEMUR

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

    GORE VIATORR TIPS ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES·Product code MIR·February 22, 2013

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTL LTD·Product code KWA·February 24, 2011

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION CONICAL REAMER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HTO·March 12, 2008

    PICC

    FDA Adverse Event
    Malfunction ·PFM MEDICAL, INC.·Product code LJS·April 8, 2024

    TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·March 3, 2016

    NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·March 3, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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