12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLAMPFIX
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481119620·LOCATOR F-Tx Abutment For Regular Platform One ...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481120770·Attachment System, RP, Tissue Level, Blue Sky B...
LEONE SPA
FDA UDI
LEONE SPA·08033707065685·INTRAORAL ELASTICS 4,5 oz 1/8" brown
NGB-003 Needle-guided Bracket/VET
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904017914·
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STACKHOUSE LENS HOOD, MODEL SA-700/F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 2, 2013
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
FDA Recall
Terminated
·Guidant Corporation·Product code KRG·June 17, 2005