18 results · 32ms · Sources: EU EUDAMED, US FDA

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ARTHREX SCAPHOLUNATE ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

OsteoMed

FDA UDI
OSTEOMED LLC·00845694052474·1.6mm Extended Twist Drill, 6mm STOP, Hex Shank

Tandry Locking Plate System

FDA UDI
MICROWARE PRECISION CO., LTD.·04719873098453·2.4mm Locking Volar Distal Radius Plate, 6 Hole...

CONCORD 88

FDA 510(k)
FDA Class 2 ·Dental

MYRAY HYPERION

FDA 510(k)
FDA Class 2 ·Dental

FIBULA COMP LOCK PLATE 10H STE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 21, 2011

CORONOID PLATE RT STE

FDA Adverse Event
Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

ARROW CATH RADIAL ARTERY

FDA Adverse Event
Injury ·ARROW INTERNATIONAL, INC.·Product code DQO·May 8, 2013

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·June 2, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Death ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 12, 2008

S3 SHOULDER PLATE 4 HOLE RIGHT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code FGE·May 9, 2013

BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code NTE·November 16, 2023

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

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

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025