26 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
FDA Enforcement
Class III
·Terminated·DePuy Orthopaedics, Inc.·May 22, 2013
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class III
·Terminated·Lab Vision Corporation·December 2, 2015
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
FDA Enforcement
Class III
·Terminated·Carestream Health, Inc.·February 13, 2013
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
FDA Enforcement
Class III
·Terminated·OrthoPediatrics Corp·December 28, 2016
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
Optilite IgG4 Kit Product Code: LK009.OPT.A
FDA Enforcement
Class III
·Terminated·The Binding Site Group, Ltd.·February 1, 2017
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
FDA Enforcement
Class III
·Ongoing·Owens & Minor Distribution, Inc.·February 15, 2023
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·March 17, 2021
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
FDA Enforcement
Class III
·Terminated·Optovue, Inc.·June 12, 2013
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps
FDA Enforcement
Class III
·Terminated·OriGen Biomedical, Inc.·April 21, 2021
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·August 6, 2014
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
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 10, 2013
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·November 2, 2016
PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·November 2, 2016
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
FDA Enforcement
Class III
·Terminated·Riverpoint Medical, LLC·February 6, 2019
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
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2013