29 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
×
Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·June 3, 2015
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·February 19, 2014
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
FDA Enforcement
Class III
·Terminated·R & D Systems, Inc.·November 14, 2018
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·February 26, 2020
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
FDA Enforcement
Class III
·Terminated·Volk Optical Inc·March 27, 2013
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories·October 30, 2013
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
FDA Enforcement
Class III
·Terminated·Bio-Rad Laboratories, Inc.·July 1, 2015
Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM
FDA Enforcement
Class III
·Terminated·Bio-rad Laboratories, Inc.·May 22, 2013
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
FDA Enforcement
Class III
·Ongoing·Agilent Technologies, Inc.·July 20, 2022
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·December 30, 2020
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·September 25, 2019
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
FDA Enforcement
Class III
·Terminated·Remel Inc·December 25, 2013
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
FDA Enforcement
Class III
·Terminated·C.R. Bard, Inc.·November 11, 2015
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
FDA Enforcement
Class III
·Terminated·Tapemark Company·January 12, 2022
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
FDA Enforcement
Class III
·Terminated·Steris Corporation·September 12, 2012