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

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TARRY MEDICAL TEMPERATURE PROBES

FDA 510(k)
FDA Class 2 ·General Hospital

HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

PROGRASP FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 22, 2014

MEDTRONIC MINIMED 670G

FDA Adverse Event
Injury ·MEDTRONIC·Product code CGA·December 6, 2016

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code FSA·April 22, 2013

EZ-PRO R4 AMBUL COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·April 19, 2011

MARQUIS DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code LWS·July 10, 2008

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60

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