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

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    36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Orthonol

    FDA UDI
    Rmo, Inc.·00885797021090·ORTHONOL NITI PREFORMED EXPANDED ARCH MX/MN .01...

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690743·Titanium Anatomic Angulated Concave Abutment In...

    Vari-Simplex - TMA

    FDA UDI
    ORMCO CORPORATION·00889989026641·ARCH ALEXAND TMA LO SML 019X025 PK/10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190059·EAG Ankle Clamp w/ Flippers

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws

    DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    MAST QUADRANT RETRACTOR SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code FSZ·July 3, 2008

    ENCODER ASSY J4: 195-00597

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·June 3, 2019

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024