96 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
×
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
FDA Enforcement
Class III
·Terminated·Quantimetrix Corporation·June 27, 2018
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Enforcement
Class III
·Terminated·Thermofisher Scientive·December 4, 2013
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·October 14, 2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Enforcement
Class III
·Terminated·Arc Medical Inc·May 20, 2015
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
FDA Enforcement
Class III
·Terminated·BD Biosciences, Systems & Reagents·August 20, 2014
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
FDA Enforcement
Class III
·Terminated·Bion Enterprises Ltd·June 12, 2013
Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
FDA Enforcement
Class III
·Terminated·Bion Enterprises Ltd·June 12, 2013
Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
FDA Enforcement
Class III
·Terminated·Bion Enterprises Ltd·June 12, 2013
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·September 21, 2022
D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
FDA Enforcement
Class III
·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013
D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
FDA Enforcement
Class III
·Terminated·Linvatec Corp. dba ConMed Linvatec·March 13, 2013
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·August 2, 2017
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
FDA Enforcement
Class III
·Terminated·OrthoPediatrics Corp·December 28, 2016
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
FDA Enforcement
Class III
·Ongoing·O&M HALYARD, INC.·April 10, 2024
FloPatch FP120, REF: FP120-FOT01-005
FDA Enforcement
Class III
·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025