49 results
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17ms
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Sources: EU EUDAMED, US FDA
AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
FDA Enforcement
Class III
·Terminated·Collagen Matrix, Inc.·November 21, 2018
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
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Enforcement
Class III
·Terminated·Applied Medical Technology Inc·March 1, 2017
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
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
Alere iScreen Dx Urine Drug Screen Card
FDA Enforcement
Class III
·Terminated·Ameditech Inc·May 9, 2018
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
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
Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
FDA Enforcement
Class III
·Terminated·Ecolab Inc·December 21, 2016
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
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·May 29, 2013
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Enforcement
Class III
·Terminated·Siemens Medical Solutions USA, Inc·August 24, 2022
Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·December 4, 2013
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
FDA Enforcement
Class III
·Terminated·Medtest Holdings, Inc.·June 14, 2017