BEUDAMED
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    GIARDIA II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BB8 Sinus Dilation Kit

    FDA UDI
    excelENT, Inc.·00860008118707·

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033274·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...

    LPC-PLUS ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE

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

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013

    OSCOM

    FDA Adverse Event
    Injury ·Product code DZE·March 24, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

    ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0°, RETRO

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·November 21, 2018

    ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWT·November 21, 2018

    ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-0

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

    ANATOMICAL SHOULDER FRACTURE, HUMERAL STEM, 7-130

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWS·November 21, 2018

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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