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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    INFINION ENHANCEMENT PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950018840·FORCEP TISSUE JACOBSON DELICATE CURVED 7-1/4" 1...

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112160·Rasp, 16 and 18 mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm

    UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·January 10, 2012

    DRIVE SHAFT FOR RIA 2 520MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·July 18, 2024

    CA090, DIRECT DRIVE LCA 3/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·March 19, 2013

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

    HEMOSTASIS INTRODUCER, SL1, 10F, 63CM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·March 11, 2008

    CFF03, 5X100 KII FIOS ADVFIX 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·September 29, 2015

    Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 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