14 results · 23ms · Sources: EU EUDAMED, US FDA

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ONESTEP ADULT MULTI-FUNCTION ELECTRODE

FDA 510(k)
FDA Class 3 ·Cardiovascular

Posted Stainless Steel Archwire

FDA UDI
Ortho Arch Company Inc·D90911074212·.017 X .025 POSTED SS RIGHT FORM WIRES 42MM (10)

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818233·Kelly Retractor 2.5 x 6.3cm (1" X 2 1/2")

SYRINGE 50ML LL TIP 1ML

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·June 6, 2025

EXACTECH GPS

FDA 510(k)
FDA Class 2 ·Neurology

MOSS MIAMI 5.5MM TITANIUM PIN NUT

FDA 510(k)
FDA Class 2 ·Orthopedic

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 31, 2012

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Death ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

SYNCHRON® URIC ACID REAGENT

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code KNK·June 1, 2011

BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·September 20, 2021

BD PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·March 4, 2022

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024