16 results
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8ms
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Sources: EU EUDAMED, US FDA
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
FDA Enforcement
Class II
·Terminated·I-Flow LLC·June 12, 2013
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 14, 2026
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 3, 2013
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 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
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 ¿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
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
FDA Enforcement
Class II
·Terminated·Westmed Inc·October 31, 2012