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

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    LEAD APRON CADDY

    FDA 510(k)
    FDA Class 1 ·Radiology

    freeflex+

    FDA UDI
    Fresenius Kabi AG·04250273729931·Reconstitute and/or admix drugs prior to admini...

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556701574·GC Initial™ MC Enamel Opal EOP3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228701031·GC Initial™ MC Enamel Opal EOP3, 20g

    SADDLE ASSEMBLY, TRACTION LIFTER

    FDA UDI
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430114670·

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78701031·Mini Sprint Bracket Roth .018" max. 1 left

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651987010·HALYARD* Gastrointestinal Anchor Set, SAF-T-PEX...

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78701031001·Mini Sprint Bracket Roth .018" max. 1 left

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78701030101·Mini Sprint Bracket Roth .018" max. 1 left

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78701030051·Mini Sprint Bracket Roth .018" max. 1 left

    HOOK, IRIS, SHEPARD U-SHAPED

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Laparoscope Lens Shield Device (LENS)

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

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 29, 2014

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·October 5, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024