3,606 results
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9ms
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Sources: EU EUDAMED, US FDA
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
FDA Enforcement
Class II
·Ongoing·Embecta Corp.·July 31, 2024
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
FDA Enforcement
Class II
·Ongoing·Thoratec Switzerland GMBH·July 3, 2024
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·June 24, 2026
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Swan-Ganz Pacing Catheter, Models: D200F7;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 18, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·December 24, 2025
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·October 29, 2025
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·May 28, 2025
BD COR System Software. Model Number: 444829.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·July 30, 2025
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
FDA Enforcement
Class II
·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·March 12, 2025
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·December 11, 2024