9 results
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6ms
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Sources: EU EUDAMED, US FDA
ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Daavlin Aquex (DAAV1000)
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
Hidrex USA DVP1000
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
Hidrex USA DP450
FDA Enforcement
Class III
·Terminated·Hidrex GmbH·March 1, 2017
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
FDA Enforcement
Class III
·Terminated·LivaNova Deutschland GmbH·March 23, 2022
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
FDA Enforcement
Class III
·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018