BEUDAMED
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    SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162191·Channels Flex Gutta Percha Points 25.06

    Safco Micro Applicators

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310206153·Safco endo nano applicator black 100

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221231314·Unitek Miniature Twin MBT LR 2Bi -17T/2A DHk 01...

    6 x 15mm CitreLock Implant

    FDA UDI
    Acuitive Technologies, Inc.·00810027270214·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight

    SURGICAL SYSTEM WITH CRYOGUIDE

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

    CYCLOTEC AMT CTI TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    INFINITY DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO., INC.·Product code DZE·March 21, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 10, 2011

    HOMEPUMP C-SERIES 270ML, 5ML/HR

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·July 22, 2015

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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