9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEGION Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Kurin Blood Culture Collection Set with Kurin Lock Technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LINOX SMART PROMRI S DX 65/15
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·November 14, 2014
ANGIO-SEAL DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·December 2, 2008
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·September 12, 2011
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·May 6, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013