BEUDAMED
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    ViewFlex™ X ICE Catheter, Sensor Enabled™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251231200·ceraMotion® Ti Chroma Concept Dentin 1, bleach,...

    VERIFYNOW-P2Y12 ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CTxx85 CT Scanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code MDB·May 5, 2023

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·December 9, 2004

    COULTER AC.T 5DIFF CAP PIERCE (CP)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    Z-LOOK3

    FDA Adverse Event
    Injury ·Z-SYSTEMS AG·Product code DZE·July 29, 2013

    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    GRYPHON T BR ANCHOR W/OC

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·December 6, 2023

    COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿ and STA Satellite¿. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·September 19, 2018

    ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021