BEUDAMED
    66 results · 24ms · Sources: EU EUDAMED, US FDA

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    VitalBeam

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018999·2.0mm X 13mm Cannulated Headless Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694068420·Cannulated 2.0 x 13mm Headless Screw Sterile Qty 5

    SANTORINI Corpectomy Cage System

    FDA UDI
    VB Spine LLC·10888857243132·Bone Packing Mold Size 12x14 mm

    EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER

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

    DIGITAL RETINAL CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·September 22, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL·Product code NAY·June 3, 2013

    ALARIS

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·July 13, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 16, 2023

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 15, 2016

    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

    FDA Enforcement
    Class II ·Terminated·SCC Soft Computer·February 18, 2015

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

    FDA Enforcement
    Class I ·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013

    Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.

    FDA Recall
    Terminated ·Trumpf Medical Systems·Product code JEA·July 24, 2013

    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code IDZ·April 4, 2013