114 results
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24ms
·
Sources: EU EUDAMED, US FDA
CurvaFix Low Profile System
FDA 510(k)
FDA Class 2
·Orthopedic
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813525296·DERMASILK NITRILE GLOVE M
FPS
FDA UDI
Tyber Medical, LLC·00810040686337·Ø2.5mm Locking Screw, VA 19mm
TMS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036089474·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252019200·ceraMotion® Me Opaque Modifier orange, 20 g / d...
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
FDA 510(k)
FDA Class 2
·Physical Medicine
HairMD
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
Exactech, Inc.·10885862523952·TRIAL, TIBIAL INSERT, SPACER, SIZE 0, 19mm
MEDFUSION 3500 SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·March 28, 2023
CONFIDA BRECKER CURVE GUIDEWIRE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DQX·July 2, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·March 28, 2019
V-PRO STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code MLR·September 16, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANFUACTURING·Product code LKK·December 4, 2008
TRIAL SPACER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTD·July 29, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
Set-Up Pack, part number PSS1305(C
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Canon Aquilion Prime, Model TSX-303A
FDA Recall
Open, Classified
·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019
Canon Aquilion One, Model TSX-301A
FDA Recall
Open, Classified
·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019
Canon Aquilion Premium, Model TSX-301B
FDA Recall
Open, Classified
·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019