102 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Video Duodenoscope
FDA Recall
Terminated
·Pentax Medical Company·Product code FDT·February 22, 2016
Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Dimension Vista IRON Flex reagent cartridges
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 23, 2016
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 24, 2017
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
3.0 mm Reaming Rod/950 mm, Sterile
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·October 3, 2016
Extraction Hook - Sterile for TI Cannulated Nails
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code LXH·October 3, 2016
McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
FDA Recall
Terminated
·CYPRESS MEDICAL PRODUCTS·Product code LYZ·October 12, 2016
Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·October 3, 2016
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·October 3, 2016
3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HSB·October 3, 2016
UroDiagnost; x-ray system. Product Code: 708033
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code IXR·July 19, 2016