175 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 10, 2015
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·April 20, 2016
Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 17, 2015
D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.
FDA Recall
Terminated
·TITAN SPINE, LLC·Product code OVE·July 20, 2015
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
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016