BEUDAMED
    39 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Enforcement
    Class II ·Terminated·Karl Storz Endoscopy·April 8, 2020

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    GE Healthcare Definium 5000 / 5220493 X-Ray System

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAC·September 26, 2012

    Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·July 9, 2012

    PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXC·March 11, 2020

    Beekley Medical 0-SPOT Mammography Skin Markers REF 652

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·May 8, 2017

    EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

    FDA Recall
    Terminated ·Edwards Lifesciences Research Medical, Inc.·Product code DXC·September 24, 2009

    Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HXC·November 7, 2008

    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.

    FDA Recall
    Terminated ·Sam Medical Products·Product code DXC·August 14, 2014

    Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box

    FDA Recall
    Terminated ·AGFA Corp.·Product code JAC·February 16, 2006

    CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure

    FDA Recall
    Terminated ·Edwards Lifesciences Research Medical, Inc.·Product code DXC·November 26, 2008

    Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·July 9, 2012

    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DXC·May 5, 2010

    S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·June 13, 2018

    Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box

    FDA Recall
    Terminated ·AGFA Corp.·Product code JAC·February 16, 2006

    DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HXC·July 24, 2012

    O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

    FDA Recall
    Terminated ·Beekley Corporation·Product code JAC·June 13, 2018

    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DXC·March 3, 2017

    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code HXC·March 12, 2015

    IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DXC·May 14, 2019