BEUDAMED
    6 results · 11ms · 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.
    Filters Status: Terminated ×

    Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product family, there are varying features, rate responsive pacing, and diagnostic data. Medtronic,Kappa 700 KD700,KD701,KD703,KD706,KDR700,KDR700V,KDR701,KDR701PTO,KDR701V,KDR701VIT,KDR703,KDR703V,KDR706,KDR706V,KDR720,KDR721,KDR730,KDR731,KDR733,KVDD700,KV DD701 Medtronic,Kappa 800 KDR801,KDR803,KDR806 Medtronic,Kappa 900 KD901,KD903,KD906,KDR901,KDR903,KDR906,KDR921,KDR931,KDR933,KVDD901 Medtronic, Enpulse DR E1DR01,E1DR06,E1DR21,E2D01,E2D03,E2DR01,E2DR03,E2DR06,E2DR06J,E2DR21,E2DR21PJ,E2DR31,E2DR31J,E2DR33,E2DR33J,E2VDD01 Medtronic, Adapta/Versa/Sensia DR ADD01,ADDR01,ADDR03,ADDR06,ADDRL1,ADDRS1,ADVDD01,SED01,SED01N,SEDR01,SEDR01N,SEDRL1,VEDR01 Medtronic, Relia RED01,REDR01,REVDD01 (approved in the US but has not been sold in US) Medtronic, Vitatron Extension G and E series DR E50A1,E60A1,G70A1 (not sold in the US)

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code NVZ·April 4, 2011

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015