BEUDAMED
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    SERRALESTER

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

    ROLLO 209X30X20,5/K612

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763005537·

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·July 5, 2017

    M6-C

    FDA UDI
    Spinal Kinetics, Inc.·00812388031244·Inserter Head, ML, G7

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0209020·CR Tibial Insert, UHMWPE + Vitamin E, Size 2, ...

    TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KLINIDRAPE REINFORCED SURGICAL GOWNS

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

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 18, 2013

    CAPSUREFIX

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

    INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 22, 2022

    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