BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED MASIMO PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    RADICAL-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·July 12, 2017

    23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·August 18, 2017

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 2, 2017

    RAD-57 CONFIGURABLE PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

    UNKNOWN REPICCI II KNEE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HRY·April 26, 2013

    CORE IMPACTION DRILL

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 26, 2011

    ACCU-CHEK TENDER INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·July 23, 2008

    RAINBOW RC-4

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

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-08123. 8 mm x 120 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024