BEUDAMED
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    OSCAR 2, MODEL 222

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SBi

    FDA UDI
    Provision·B504OM10030040·

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780145776·Integra® Jarit® T-V Spring, 1/2", For REF #600-...

    APOLLO Ankle Fracture Plating System

    FDA UDI
    Glw, Inc.·18435711003245·APOLLO Ankle Fracture Plates / Medial Mal. Plat...

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·January 11, 2025

    Diamondback Peripheral

    FDA UDI
    Cardiovascular Systems, Inc.·10852528005848·Diamondback 360 Peripheral Orbital Atherectomy ...

    MONTANETATRAS M-S2.F4 [SZER 69 CM]

    FDA UDI
    MEDEN INMED SP Z O O·05903684801480·The MONTANE treatment table is a treatment tabl...

    HARDYDISK, TETRACYCLINE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE PATELLA RESURFACING SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 12, 2021

    CANNULA, 8MM, REGULAR, IS2000

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GCJ·September 4, 2007

    BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 13, 2013

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·February 28, 2011

    ACCU-CHEK RAPID D INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·February 22, 2008

    AUTOCOMP6 XPS High Speed Compounder REF 58810

    FDA Enforcement
    Class II ·Terminated·The Metrix Company·August 3, 2016

    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011

    FDA Recall
    Terminated ·Product code LOX·August 20, 2003

    EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·March 2, 2016

    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

    FDA Enforcement
    Class II ·Terminated·Primus Medical LLC·November 14, 2012

    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