11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Access AMH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEONE SPA
FDA UDI
LEONE SPA·08033707018865·CALIBRA 1ST MOLAR BANDS n.LL 24
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POLYTEL(R) APT MODEL: PWA-08-01
FDA 510(k)
FDA Class 2
·Cardiovascular
MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA Adverse Event
Malfunction
·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015
UNKNOWN INTEGRAL BIPOLAR PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWY·January 22, 2024
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·September 11, 2008
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 16, 2019
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022