BEUDAMED
    120 results · 20ms · 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 FDA Recall ×

    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

    FDA Recall
    Terminated ·Transonic Systems Inc·Product code PEH·February 15, 2018

    Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B ; 6) ENT TRACHEOTOMY , Pack Number DYNJ55523C ; 7) DR NIELSON THORACOSCOPY , Pack Number DYNJ61471A ; 8) TRACH PACK, Pack Number DYNJ64583; 9) TRACHEOSTOMY, Pack Number DYNJ902123G; 10) TRACHEOSTOMY, Pack Number DYNJ902123I; 11) TRACHEOSTOMY, Pack Number DYNJ902123J; 12) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525 ; 13) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525H; 14) BEDSIDE TRACHEOTOMY , Pack Number DYNJ909743

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NXA·April 8, 2024

    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

    Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·June 19, 2008

    PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.

    FDA Recall
    Terminated ·Naviscan PET Systems·Product code KPS·August 1, 2007

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Recall
    Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

    Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OES·April 8, 2024

    Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT

    FDA Recall
    Terminated ·Cti Pet Systems Inc·Product code KPS·October 2, 2003

    ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL

    FDA Recall
    Terminated ·Cti Pet Systems Inc·Product code KPS·March 4, 2003

    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: Siemens Models: Biograph PET/CT CTI Models: Reveal PET/CT

    FDA Recall
    Terminated ·CTI PET Systems Inc·Product code KPS·May 27, 2004

    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

    FDA Recall
    Terminated ·CTI PET Systems Inc·Product code KPS·April 5, 2005

    HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.

    FDA Recall
    Terminated ·Healthtronics, Inc.·Product code GEH·December 20, 2012

    SurgiFrost Cryosurgical Probes

    FDA Recall
    Terminated ·Endocare Inc·Product code GEH·October 25, 2002

    Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    FDA Recall
    Terminated ·OraSure Technologies, Inc.·Product code GEH·July 15, 2020

    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.

    FDA Recall
    Terminated ·PENTAX of America Inc·Product code GEH·March 30, 2018

    IceSeed" Prostate Cryoablation Kit

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    IceRod" 1.5 MRI Cryoablation Needle

    FDA Recall
    Completed ·Boston Scientific Corporation·Product code GEH·November 18, 2020

    Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218

    FDA Recall
    Terminated ·Wallach Surgical Devices, Inc.·Product code GEH·June 6, 2007

    Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).

    FDA Recall
    Terminated ·Endocare, Division Of Healthtronics·Product code GEH·November 4, 2010