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Sources: EU EUDAMED, US FDA
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E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
FDA Recall
Terminated
·AdvanDx, Inc.·Product code OAH·June 8, 2010
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·June 2, 2021
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·March 29, 2011
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·August 15, 2011
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
FDA Recall
Terminated
·Pentax of America Inc·Product code FDT·April 21, 2021
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
BF-P60 OES Bronchofiberscope, Model No. BF-P60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOX·August 16, 2021
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021
BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 6, 2021
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 6, 2021
BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 6, 2021
BF-P60 OES Bronchofiberscope, Model No. BF-P60
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 6, 2021
BF-N20 OES Bronchofiberscope, Model No. BF-N20
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 6, 2021
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·April 1, 2020
Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPP·October 31, 2011
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code LHI·March 28, 2008
"***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS DE INFUSION I.V.***REF 259-0250***50 UNITS***STERILE OE***LATEX-FREE***LEVENTON LEVENTON, S.A.U. C/Newton, 18-24 08635 Sant Esteve Sesrovires BARCELONA-SPAIN***Distributed by: Victus www.victus.com 4918 S.W. 74th Court Miami, FL 33155***" To control intravascular infusion of medication.
FDA Recall
Terminated
·Leventon S. A. U. C/ Newton, 18-24 Sant Esteve Sesrovires Barcelona Spain·Product code LDR·March 11, 2011
Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·November 17, 2008