14 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 28, 2018
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 28, 2018
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 13, 2022
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 3, 2020
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
FDA Recall
Terminated
·Myolyn Inc.·Product code GZI·July 19, 2022
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
FDA Recall
Terminated
·Smith & Nephew Inc·Product code JWH·April 19, 2022
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
FDA Recall
Terminated
·Product code LXH·March 30, 2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
FDA Recall
Terminated
·Product code LXH·March 30, 2022
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
FDA Recall
Terminated
·Product code LXH·March 30, 2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·May 19, 2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Recall
Terminated
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·May 19, 2022
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
FDA Recall
Terminated
·Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany·Product code JDR·January 18, 2022