241 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·December 31, 2014
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·May 22, 2013
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.
FDA Enforcement
Class II
·Terminated·SRI Surgical·September 5, 2012
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·September 2, 2015
ARIES System and ARIES M1 System
FDA Enforcement
Class II
·Terminated·Luminex Corporation·May 24, 2017
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
FDA Enforcement
Class II
·Terminated·Luminex Corporation·August 28, 2019
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
FDA Enforcement
Class II
·Ongoing·Luminex Corporation·August 21, 2019
TriFoillmaging Triumph/Triumph II Research CT scanners.
FDA Enforcement
Class II
·Terminated·Northridge Tri-Modality Imaging,·October 12, 2016
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·April 15, 2015
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 18, 2019