BEUDAMED
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    OSTEON, OSTEON SINUS, OSTEON LIFTING

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169413627·BLADE 5102015 20MM WIDE VESSELBLADE 15CM

    Jelco

    FDA UDI
    ICU MEDICAL, INC.·00351688072996·

    RHEAD

    FDA UDI
    Stryker GmbH·00886385024066·Stem Implant 6mm Collar,Size 2

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193108100·HA PEEK EVOS Straight, ,15mmx8mmx 30mm , FLAT ...

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795134585·2.0mm Drill Bit, Calibrated, AO Quick Connect

    VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PILLCAM

    FDA Adverse Event
    Injury ·GIVEN IMAGING LTD., YOQNEAM·Product code NSI·November 2, 2018

    ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH

    FDA Adverse Event
    Malfunction ·CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.·Product code EZQ·September 3, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 2, 2015

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 3, 2013

    SAGITTAL BLADE

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD.·Product code GFA·April 13, 2011

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·August 7, 2008

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·January 25, 2017

    rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025