14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Genius Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003722·MCK BASEPLATE TRIAL (SIZE 3 RM/LL)
n/a
FDA UDI
Ortho Development Corporation·00822409091720·Diamond Tooth Broaches Size 13
BIOMED WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General Hospital
TI LAMINA HOOK-/ LEFT
FDA Adverse Event
Malfunction
·SYNTHES BRADUWOME·Product code KWP·February 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·September 16, 2008
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·June 28, 2017
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 19, 2020
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023