14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425499151·MOSQUITO HEMOSTAT STRAIGHT
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122254·KWire .062x4" (1.6x100mm)
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEOTRACT ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIRTUOSO II DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·July 8, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·September 19, 2018
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·March 8, 2021
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
GRACE MEDICAL, INC. NOTCHED TITANIUM BUCKET HANDLE
FDA Adverse Event
Injury
·GRACE MEDICAL, INC.·Product code ETB·July 3, 2019
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·October 14, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021