BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reicodent

    FDA UDI
    devemed GmbH·04061644046577·Operating micro-scissors 12 cm "Noyes" curved

    Reicodent

    FDA UDI
    devemed GmbH·04061644046584·Operating micro-scissors 14,5 cm "Noyes" curved

    Reicodent

    FDA UDI
    devemed GmbH·04061644046591·Operating micro-scissors 15 cm curved

    SunMed

    FDA UDI
    SUNMED, LLC·10889483036198·E/T INTRODUCER PEDIATRIC 10FR BX/10

    DIGORA PCT

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reicodent

    FDA UDI
    devemed GmbH·04061644039579·Operating micro-scissors 160 mm "Gomel"; curved...

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    EXACTA, 100ML DRIP CHAMBER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·March 28, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·June 29, 2022

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES PR·Product code FRO·September 6, 2023

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·March 15, 2022

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014