15 results
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8ms
·
Sources: EU EUDAMED, US FDA
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 29, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·October 13, 2021
6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·October 6, 2021
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
FDA Enforcement
Class II
·Ongoing·Datascope Corp.·September 6, 2023
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014