BEUDAMED
    13 results · 22ms · 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 ×

    CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609591·BERCHTOLD 4.25" SOFTCARE PLUS

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044202120·30 mL / 15 mL Prefilled Histoware Vials with Caps

    MODIFICATION TO SOLO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 26, 2013

    SAM JUNCTIONAL TOURNIQUET (SJT)

    FDA Adverse Event
    Malfunction ·SAM MEDICAL PRODUCTS·Product code DXC·August 29, 2014

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 14, 2011

    DAVINCI SI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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