10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Philips iCT CT system
FDA 510(k)
FDA Class 2
·Radiology
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm
FDA 510(k)
FDA Class 2
·Orthopedic
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIO VASCULAR·Product code MIH·December 3, 2008
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·September 9, 2011
ARMADA 35 PTA CATHETER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code LIT·July 26, 2013
CTF03, 5X100 KII FIOS Z-THR 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·December 3, 2015
CTS02, 5X100 KII SLEEVE ZTHR 12/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·December 3, 2015
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