BEUDAMED
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    CABLECAP MODEL: WLF, STZ, ACM

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

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10193489491791·PACEMAKER KIT

    SleepWeaver 3D Mask only - Blue

    FDA UDI
    CIRCADIANCE, LLC·B036101496·SleepWeaver 3D Mask only - Blue

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111338700·SPONGE BOWL 12 OZ

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501255·Gutta Percha Points is used to root canal filin...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111264409·SPONGE BOWL 12 OZ. PACK OF 12

    A.V. FISTULA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code MEG·April 3, 2023

    BD ALLERGY TRAY SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code MEG·March 9, 2023

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·December 19, 2017

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2013

    FUJINON

    FDA Adverse Event
    FUJIFILM OPTICS CO., LTD. MITO FACTORY·Product code FDA·August 27, 2014

    DUROM US ACETABULAR COMPONENT 50/44 J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 17, 2011

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021