609 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
FDA Enforcement
Class III
·Terminated·Remel Inc·September 4, 2013
GlideScope Go Monitors
FDA Enforcement
Class III
·Ongoing·Verathon, Inc.·August 11, 2021
VenaSeal Closure System
FDA Enforcement
Class III
·Ongoing·Medtronic Inc.·May 19, 2021
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
FDA Enforcement
Class III
·Terminated·Remel Inc·August 21, 2013
KWIK-STIK" plus: Clostridium perfringens
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·June 1, 2022
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
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·December 10, 2014
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
FDA Enforcement
Class III
·Terminated·Nanosphere, Inc.·September 3, 2014
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
10-Panel Pipette Drug Screen, Item No. PSP-10M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 10 Panel Cup, Item No. PSCup-10M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015