11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DISPOSABLE PROPHYLAXIS ANGLE
FDA 510(k)
FDA Class 1
·Dental
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295230267·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP...
Elite® Buccal Tubes Direct Bond
FDA UDI
Ortho Organizers, Inc.·00190707074425·Elite®.018 EDGE L7L MINI HK DB
MectaLIF 3D Metal
FDA 510(k)
FDA Class 2
·Orthopedic
PASSY-MUIR TRACH VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
COULTER® ACT DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC·Product code GKZ·December 7, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 8, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 6, 2011
G7 SCREW 6.5MM X 30MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·July 22, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017