71 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·May 14, 2025
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·January 30, 2013
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·October 30, 2013
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·July 23, 2014
BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 17, 2015
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
FDA Enforcement
Class II
·Terminated·Prodimed Plastimed Division·July 15, 2020
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
FDA Enforcement
Class II
·Terminated·Prodimed Plastimed Division·July 15, 2020
BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2013
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA Enforcement
Class II
·Ongoing·Copan Italia·June 18, 2025
VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 5, 2013
VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2013
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 5, 2013
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·March 12, 2025
BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·December 12, 2018
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·December 19, 2012