BEUDAMED
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    UHR UNIVERSAL6HIP REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUMED

    FDA UDI
    Acumed LLC·10806378040474·Acutrak® 4/5 Trephine

    Falcon

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730088406·Posterior Band Removing Pliers - Long

    Spetzler, Claw

    FDA UDI
    STRYKER CORPORATION·07613252026525·Spetzler/Claw Tip

    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DANYANG HUAYI K2 AND K7 WHEELCHAIRS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NORMAL SALINE PREFILLED FLUSH

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code FOZ·March 29, 2001

    EEA XL 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GAG·April 28, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007

    PRODIGY LG STAT SHT LT 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016

    PRODIGY LG STAT LNG LT 13.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

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