13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biofeedback Nerve and Muscle Stimulator
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KeyPrint
FDA UDI
Keystone Industries·H66842201611·KeySplint Soft Clear Resin ,1kg
NA
FDA UDI
Smith & Nephew, Inc.·23596010103868·Stainless Steel TROCANTERIC WIRE
...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM
CERTAIN® GOLD-TITE® HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·April 17, 2019
ALPHAPOINT IMAGING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·November 3, 2014
STANDARD CONSOLE W/IRRIGATION FOR ELECTRIC PEN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code DZI·August 16, 2011
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025