40 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707002161·AUSTRALIAN WIRE EXTRA SPRING HARD 18
.
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306836244·Fistula Duct Probe,Probe & Needle Eye, Silver: ...
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105191·HOLLAND DALK SICISSORS RIGHT
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710300420180·Tibial Osteotmy Guide, 42mm x 18mm
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356610·
NDO SURGICAL SURGICAL OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEART START XL
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 2, 2013
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 31, 2011
VITALITY 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·November 4, 2019
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Death
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 24, 2018
OARM 1000 IMAGING SYSTEM
FDA Adverse Event
Death
·MEDTRONIC NAVIGATION, INC·Product code OXO·October 24, 2018
NI
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·October 25, 2018
MEDTRONIC NAVIGATION
FDA Adverse Event
Death
·MEDTRONIC NAVIGATION, INC·Product code HAW·November 4, 2019
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·August 6, 2018
Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 7, 2018
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·August 6, 2018