15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE WAND MICROACCESS SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·February 26, 2014
LIGHTLAS 532 PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH
FDA Adverse Event
Other
·INTEGRA, PLAINSBORO·Product code JXI·May 17, 2011
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013
MX-PRO AMBULANCE COT OBS 10/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 2, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·May 16, 2011
Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEW·April 22, 2010
Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEW·April 22, 2010