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

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    FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019904·The ENDO CARRY-ON Procedure Kit contains all of...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026380·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GAG·June 29, 1994

    REDUCER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    STABILITY THREAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code KDC·June 29, 1994

    O-RING PROSTHETIC ATTACHMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    RESPONDER 3000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    TAXUS¿ ELEMENT¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 13, 2013

    BCS(R) XP SYSTEM

    FDA Adverse Event
    Injury ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GJS·February 28, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 8, 2008

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIM·July 26, 2011

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024