96 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Recall
Terminated
·Medtronic·Product code FCG·February 8, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
FDA Recall
Terminated
·Medtronic·Product code FCG·February 8, 2017
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·October 6, 2021
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
FDA Recall
Terminated
·BSN Medical Inc·Product code FQM·February 1, 2022
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code KGX·November 21, 2019
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
FDA Recall
Terminated
·Sequent Medical Inc·Product code KRA·September 23, 2016
Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFR·April 3, 2008
Access and Access 2 Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CGN·April 3, 2008
UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 3, 2008
SYNCHRON LXi 725 System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JGS·April 3, 2008
200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
FDA Recall
Terminated
·Mako Surgical Corporation·Product code HAW·July 17, 2009
iPico Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Perfector Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
Ion Magnum Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012
IELLIOS Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code NFO·January 6, 2012
Arasys Product Usage: Muscle stimulation
FDA Recall
Terminated
·Ion Genius, Inc.·Product code IPF·January 6, 2012