47 results
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13ms
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Sources: EU EUDAMED, US FDA
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·July 31, 2019
IceSeed" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceRod" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceSeed" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
Five IceSphere" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceRod" He-Thaw Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
FDA Enforcement
Class II
·Completed·Ultradent Products, Inc.·July 20, 2022
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
Five IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Enforcement
Class II
·Completed·Boston Scientific Corporation·December 30, 2020
Vasc Custom Kit - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Enforcement
Class II
·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
FDA Enforcement
Class II
·Completed·Bioseal Corporation·May 26, 2021
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
FDA Enforcement
Class II
·Completed·Landauer·September 20, 2023