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

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    HARMONIC 10CM COMBINATION HOOK BLADE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215021603·

    Crescendo Meniscal Insert CR Ultracongruent 10mm Size 3

    FDA UDI
    AMPLITUDE SAS·03701089524612·

    ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLAY-PARK LABS, INC. - LUBRICATING JELLY

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

    RENAL UROLOGY STENT K072293

    FDA Adverse Event
    Other ·FOSSA MEDICAL INC·Product code FAD·April 10, 2014

    NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

    FDA Adverse Event
    Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    DYNASTY(R) A-CLASS(R) POLY LINER

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·April 28, 2011

    TENAX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    UNK HARMONYCA LIDOCAINE

    FDA Adverse Event
    Injury ·PANAXIA LTD·Product code LMH·August 17, 2023

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Enforcement
    Class III ·Terminated·Viscot Medical LLC·April 10, 2013

    CryoValve Heart-valve, allograft

    FDA Recall
    Terminated ·Cryolife Inc·Product code LMO·March 19, 2003

    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    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