63 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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MediSpectra Luma Cervical Imaging System Model Number: 3-02600
FDA Recall
Terminated
·Medispectra Inc.·Product code MWM·May 15, 2007
VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 21, 2011
TotalCare beds P1900 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 21, 2011
VersaCare P500 Microclimate Management Surface Upgrade Kits P3218A and P3219A Hill-rom Batesville, IN. The TotalCare Bed Systems is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·February 21, 2011
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
FDA Enforcement
Class II
·Terminated·Illumina Inc·September 17, 2014
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
FDA Recall
Terminated
·Illumina Inc·Product code PFF·July 28, 2014
Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
FDA Recall
Terminated
·Life Technologies, Corp.·Product code KIT·August 24, 2018
Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
FDA Enforcement
Class II
·Terminated·Life Technologies, Corp.·October 24, 2018
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Recall
Terminated
·MWT Materials, Inc.·Product code LNH·October 6, 2014