234 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
FDA Enforcement
Class II
·Terminated·Abaxis Inc·June 24, 2020
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
FDA Recall
Terminated
·Covidien LLC·Product code FSY·April 16, 2015
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code LLL·November 25, 2008
MAS Omni Immune Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
MAS Omni Immune PRO Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·February 11, 2015
MAS Omni Immune Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
MAS Omni Immune PRO Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code GGK·December 19, 2007
Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·February 6, 2009
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·January 15, 2015
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
FDA Recall
Terminated
·Baxter Corporation Englewood·Product code NEP·April 8, 2015
ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code DHN·December 4, 2008
Lodox Statscan digital radiographic system.
FDA Recall
Terminated
·Lodox Na Llc·May 10, 2004
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Leeds, United Kingdom.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code KWA·March 5, 2010
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 60/54, code T, Zimmer, Winterthur, Switzerland; REF 01.00214.160. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)
FDA Recall
Terminated
·Zimmer Inc.·Product code KWA·July 22, 2008
Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement)
FDA Recall
Terminated
·Zimmer Inc.·Product code KWA·July 22, 2008