10 results
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15ms
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Sources: EU EUDAMED, US FDA
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
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2024
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 7, 2018
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
FDA Enforcement
Class II
·Ongoing·Galt Medical Corporation·June 21, 2023
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T
FDA Enforcement
Class II
·Ongoing·BD SWITZERLAND SARL·June 18, 2025