16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APPROACH PRO ST WIRE GUIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
MAKO SURGICAL CORP.·00848486017088·STRAIGHT HEX DRIVER 200mm LENGTH
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642108774·Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 9 ...
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERCISE GENUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·October 31, 2024
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 13, 2013
UNIVERSAL DRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·May 19, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008
GMK HINGE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·March 2, 2026
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
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