BEUDAMED
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    PROTEIN S AC

    FDA 510(k)
    FDA Class 2 ·Hematology

    Safco polycarbonate crowns

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310222903·Safco polycarbonate crowns #37 5/box

    SPAN MEDICAL PRODUCTS CANADA ULC

    FDA registration
    SPAN MEDICAL PRODUCTS CANADA ULC·2 products·🇨🇦 Canada

    RAPIDIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 16, 2010

    8022290-2001-00001

    FDA Adverse Event
    Death ·Product code FNL·January 25, 2001

    8022290-2001-00002

    FDA Adverse Event
    Death ·Product code FNG·April 6, 2001

    8022290-2001-00003

    FDA Adverse Event
    Death ·Product code ---·May 7, 2001

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

    BD TEST STRIPS

    FDA Adverse Event
    Other ·Product code NBW·January 24, 2008

    BD ALARIS¿ SMARTSITE¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 23, 2023

    STOCKERT CORONARY PERFUSION CANNULAE

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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