47 results · 13ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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