BEUDAMED
    35 results · 21ms · Sources: EU EUDAMED, US FDA

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    HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799349·MANUMED ACTIVE WRIST RIGHT SILVER XS

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776295516·ECONOMY LINE Crile Forceps straight 5.5"

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104332·Rod Straight 5.5 x 110mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVEA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AVEA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 17, 2015

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·September 2, 2014

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 20, 2011

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code MAF·September 11, 2009

    Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code MCX·October 9, 2015

    Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010