BEUDAMED
    23 results · 26ms · Sources: EU EUDAMED, US FDA

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    UltraFlex IAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PureLife Dental

    FDA UDI
    PURELIFE, LLC·D79011901011·2 1/4" x 4" Sterilization Pouches, Built-in col...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199236·AK3 PS Notch Reamer Guide Size 1

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481124594·LOCATOR R-Tx Attachment System, FairTwo L, Fair...

    HIPLOC SYSTEM

    FDA UDI
    Biomet Uk Ltd·05019279410101·

    TIBIAL INSERT IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS, INC.·Product code OOG·April 28, 2017

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780372981·Integra® Jarit® Flexible Shaft Retractor, 6", 2...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821844·Billeau Ear Loop - Size 1, Flexible: 14cm

    GSP NEONATALGALT KIT, MODEL 3303-001U

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS

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

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402078·Broach, Tibial Cone, XS Half

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111901010·Orion Stem, H/O (Lateralized) - Size 1

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    ELECTRIC CHAIR

    FDA Adverse Event
    Malfunction ·HOVEROUND·Product code ITI·October 15, 2014

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LMH·June 17, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·June 30, 2011

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·December 29, 2021

    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only

    FDA Enforcement
    Class I ·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019