62 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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Kit BD Max CT/GC/TV; Catalog # 442970
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·December 30, 2020
fastener, fixation, nondegradable, soft tissue
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 15, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code OUG·January 17, 2020
CADD Administration Sets, Model #21-7346-24
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FPA·July 14, 2020
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
FDA Recall
Terminated
·Product code NKG·December 14, 2020
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAK·November 24, 2020
NM 830 Model # H3910AC
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 DR Model # H3100AS
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery 670 DR Model # H3100BT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 860, SPECT/CT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM 630 Model # H3101RH
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 CZT Model # H3906CW
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 850 Model Number: H3907AD
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM670 Pro Model # H3100XB
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
FDA Recall
Terminated
·Cook Inc.·Product code MIH·January 16, 2020