BEUDAMED
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    ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bard® Heyman Follower

    FDA UDI
    C. R. Bard, Inc.·00801741075575·Bard® Heyman Follower

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854008096·ULTRAPOWER BUR, ROUND(COPPER), 2 MM

    HEMOSIL HIGH ABNORMAL CONTROL ASSAYED

    FDA 510(k)
    FDA Class 2 ·Hematology

    MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

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

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 27, 2008

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·September 13, 2021

    UROPASS AS 12/14FR X 24 CM 5/BX

    FDA Adverse Event
    Injury ·GYRUS ACMI, INC.·Product code KNY·August 29, 2022

    URETERO-RENO FIBERSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FGB·August 29, 2022

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 4, 2023

    PENTAX MEDICAL

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 22, 2026

    BACT/ALERT I NST 100 BTLS - 259785

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·October 28, 2019

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013