BEUDAMED
    24 results · 31ms · Sources: EU EUDAMED, US FDA

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    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 20, 2006

    COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE

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

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 21, 2006

    Safco Surgical Aspirator Tips

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310227153·Safco surgical aspirator tips, blue, 1/16 hole,...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837026523·PLATEAU Interbody, Straight, Bulleted, 10mm 22m...

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080227150·27mm x 15mm Non-Lordotic Spacer

    ECAT PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AP II PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE PTE. LTD·Product code MEA·October 4, 2001

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 27, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 17, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 26, 2008

    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

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 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