BEUDAMED
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    APEX 800 LASER SYSTEM, MODEL APEX 800

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

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093868·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 0T/1...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062840·Mini Uni-Twin(TM) Bracket APC(TM) II UL3 0T/11A...

    3M™ Unitek™ Uni-Twin™

    FDA UDI
    3M UNITEK CORPORATION·00652221016942·Mini Uni-Twin(TM) Bracket UL3 0T/11A Hk .018 5/Pk

    SOFTFORM FACIAL IMPLANT

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

    PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PARAPAC 'MEDIC' (K020899)

    FDA Adverse Event
    Death ·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·March 16, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

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