8 results
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11ms
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Sources: EU EUDAMED, US FDA
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·June 28, 2017
Merge PACS software. The firm name on the label is Merge Healthcare.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 15, 2017
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
FDA Enforcement
Class II
·Terminated·Miami Fat Supply, Inc·June 22, 2016
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
FDA Enforcement
Class II
·Terminated·DT MedTech, LLC·November 14, 2018