13 results
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14ms
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Sources: EU EUDAMED, US FDA
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·December 18, 2019
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·August 22, 2018
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.
FDA Enforcement
Class III
·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
FDA Enforcement
Class II
·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017