12 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 18, 2020
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE LF ECG SNAP ENDS IEC GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS AHA GRAY, CBL 10WIRE LF LRG ECG SNAP ENDS IEC GRAY. The S4 mobile monitor provides a means to acquire and transmit simultaneous ECG and SpO2 data to a Surveyor Central Station monitoring system while allowing the patient to be ambulatory within the range of the WiFi network.
FDA Enforcement
Class II
·Terminated·WELCH ALLYN, INC/MORTARA·May 6, 2020
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·June 17, 2020
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·April 27, 2022
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·April 27, 2022
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·February 3, 2021
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
FDA Enforcement
Class II
·Ongoing·Qiagen Sciences LLC·September 7, 2022
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
FDA Enforcement
Class II
·Ongoing·Qiagen GmbH·October 11, 2023
(1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
FDA Enforcement
Class II
·Terminated·COVIDIEN MEDTRONIC·May 23, 2018