BEUDAMED
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    TECHNICATOR

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

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581270200001·A-FIT® 2. MOLAR UPR LFT SZ 02

    BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    10MM/125 DEG TI CANN TFNA 170MM - STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·February 8, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 15, 2014

    SECURA VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 24, 2010

    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 28, 2025

    Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 13, 2025

    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·June 30, 2025

    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

    FDA Enforcement
    Class II ·Ongoing·Philips North America·August 6, 2025

    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    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