16 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code FEB·September 11, 2008
ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code KOG·February 19, 2010
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
FDA Recall
Terminated
·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 26, 2016
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
FDA Enforcement
Class II
·Terminated·Custom Ultrasonics, Inc.·July 13, 2016
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
FDA Recall
Terminated
·Minntech Corp·Product code FEB·June 15, 2010
Flexible Intubation Fiberscope, Model # 11301AB1
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EOQ·April 24, 2019
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·December 14, 2007
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code DER·May 16, 2018
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018
Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FEB·June 23, 2016
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
FDA Recall
Terminated
·Carestream Health Inc·Product code LLZ·April 15, 2016
QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
FDA Recall
Terminated
·Z-Medica, LLC·Product code FRO·November 17, 2017
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States
FDA Recall
Terminated
·Carestream Health Inc·Product code LLZ·April 15, 2016