59 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.
FDA Recall
Terminated
·C.R. Bard, Inc., Urological Division·Product code BSY·September 28, 2005
Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.
FDA Recall
Terminated
·Brookstone Company, Inc.·November 2, 2012
The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D
FDA Recall
Terminated
·Orbus Medical Technologies Inc·Product code MEW·March 19, 2004
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
FDA Recall
Terminated
·Gendex Corp·Product code EHD·August 12, 2014
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
FDA Recall
Terminated
·Ascension Orthopedics, Inc·Product code HSD·November 16, 2018
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Abbott Laboratories, Diagnostic Division, Abbott Park, IL 60064 USA; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma.
FDA Recall
Terminated
·Abbott Laboratories·Product code JJE·April 24, 2009
MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP.
FDA Recall
Terminated
·MIMvista Corp·Product code LLZ·April 23, 2008
CBS micro, countersink, cannulated, AO, Item Number 503004541
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
V-TEK", micro-countersink, round shaft, Item Number 28.66.112
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
V-TEK", Micro-countersink, AO, Item Number 28.66.113
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019