BEUDAMED
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    MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Phantom Tibial Preparation

    FDA UDI
    ADLER ORTHO SPA·08052693623525·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.3

    Hader

    FDA UDI
    Preat Corporation·00842092105375·Hader Green Processing Spacer

    Luxe™ 2.5 Semi-custom loupe

    FDA UDI
    METREX RESEARCH, LLC·00850036373643·Semi-custom loupe with Luxe™ 2.5 plano oculars,...

    SONTEC CASTROVIEJO EYE SPECULUM

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896012035·SONTEC CASTROVIEJO EYE SPECULUM LARGE SIZE #3

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071017031C0·Custom Curette #3 angled 17" length 9" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071017033CT0·Toothed Curette #3 Right Angle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071017034CT0·Toothed Curette #3 Left Angle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071017031S250·#3 Angled Curette .25 Shaft REV 0

    PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

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

    LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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

    IO-FLEX

    FDA Adverse Event
    Malfunction ·BAXANO, INC.·Product code HAE·December 23, 2013

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

    TOTALCARE BARIATRIC BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 30, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 11, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·August 7, 2008

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Pulsar Max II Multiprogrammable Pacemaker, Model 1280

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·June 23, 2003

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025