BEUDAMED
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    3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICASEPT CIRADUR SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09920928530·MICASEPT CIRADUR METZENBAUM SCISSORS MONOPOLAR ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450385746·

    SCITON IMAGE HAIR REMOVAL LASER

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

    SMART GLOVE STERILE NITRILE EXAM GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QUADRA H CEMENTLESS STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 3, 2015

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 3, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·August 20, 2014

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC.·Product code FOZ·May 11, 2011

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021