10,000 results
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31ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
FDA Enforcement
Class II
·Terminated·MEDLINE IND·January 18, 2017
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
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
FDA Enforcement
Class II
·Ongoing·Smith & Nephew Inc.·December 11, 2024