211 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
FDA Recall
Terminated
·Nextremity Solutions·Product code HWC·November 11, 2019
Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
FDA Recall
Terminated
·Nextremity Solutions·Product code HWC·November 11, 2019
Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
FDA Recall
Terminated
·Nextremity Solutions·Product code HWC·November 11, 2019
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario·Product code NAW·February 24, 2009
ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. Made in USA. ST ULTRAPOWER BUR Diamond Wheel/MDS TU-51 (TEAL) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702149200, STERILE. Made is USA. Single use devices. CONMED LINVATEC 11311 Concept Blvd Largo, FL 33773-4908 Surgical instrument motors and accessories are AC-powered, or air-powered devices intended for the use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, a chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code HTT·July 31, 2009
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
FDA Recall
Terminated
·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code QDI·January 18, 2022
Theratron Elite 80 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Phoenix Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780C Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Elite 100 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
FDA Recall
Open, Classified
·NxStage MDS Corporation·Product code KDI·January 29, 2024
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.
FDA Recall
Terminated
·Agilent Technologies, Inc.·Product code PJC·June 17, 2015
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FPA·May 2, 2019
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FOZ·March 1, 2019
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and Connecta Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
FDA Recall
Open, Classified
·Product code FMG·February 20, 2025
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
FDA Recall
Terminated
·Becton Dickinson & Company·Product code PTI·June 19, 2020
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
FDA Recall
Open, Classified
·CAREFUSION·Product code FPA·August 2, 2021