209 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Enforcement
Class III
·Terminated·LumiraDx·November 2, 2022
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics, INc.·June 2, 2021
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Recall
Terminated
·LumiraDx·Product code QKP·September 23, 2022
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, INc.·Product code QKP·May 3, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
FDA Enforcement
Class II
·Terminated·LumiraDx·February 24, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
FDA Recall
Terminated
·LumiraDx·Product code QKP·January 11, 2021
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Recall
Terminated
·Zimmer CAS·Product code JWH·November 3, 2014
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Recall
Terminated
·Zimmer CAS·Product code OLO·April 19, 2015
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Enforcement
Class II
·Terminated·Ceg Enterprises Llc·June 29, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005