578 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.
FDA Recall
Terminated
·Western a Scott Fetzer Company·Product code CAN·August 10, 2009
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope
FDA Recall
Completed
·Shent USA, Inc.·Product code OCZ·January 12, 2021
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
FDA Recall
Completed
·Shent USA, Inc.·Product code OCZ·January 12, 2021
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code ODC·May 12, 2026
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Recall
Terminated
·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016
Bio-CORE Cannula (Needle) Set
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGI·August 26, 2020
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV fluid administration.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FGY·November 26, 2013
Bio-MAC Cannula (Needle) Set
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FGY·October 31, 2005
Bio-PLASTY Cannula (Needle)
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGI·December 8, 2009
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FGY·May 14, 2013
Hobbs Scope Introducer Catalog Number: 4650
FDA Recall
Open, Classified
·Hobbs Medical, Inc.·Product code FGY·July 29, 2022
Radioimmunoassay, Estriol
FDA classification
FDA Class 1
·Radioimmunoassay, Estriol
Breast Milk, Rhodamine, Antigen, Antiserum, Control
FDA classification
FDA Class 1
·Breast Milk, Rhodamine, Antigen, Antiserum, Control
Hemostatic Metal Clip For The Gi Tract
FDA classification
FDA Class 2
·Hemostatic Metal Clip For The Gi Tract