BEUDAMED
    16 results · 30ms · 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 ×

    PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482051023·Symmetry® Scissors, Operating, Straight, Sharp/...

    Mobilio

    FDA UDI
    Ropox A/S·05707581000638·

    ELECSYS TESTOSTERONE CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHILI VIDEO, CHILI VIDEOPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

    PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

    TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

    COBAS INTEGRA 400 PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 7, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008

    PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018

    McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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