22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Revolution CT
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550179·GENUMEDI PT KNEE SUP SILVER R EW III
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704450019·
LINK Instruments - Alignment and positioning instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397655·Orthopaedic implant aiming/guiding block, reusa...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187164·Femoral stem prosthesis trial - Megasystem-C Tu...
LINK Instruments - Alignment and positioning instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397679·Orthopaedic implant aiming/guiding block, reusa...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187157·Femoral stem prosthesis trial - Megasystem-C Tu...
LINK Instruments - Alignment and positioning instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575397662·Orthopaedic implant aiming/guiding block, reusa...
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FINESS ENDOSCOPE STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·November 7, 2016
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
PROMUS ELEMENT? PLUS
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 11, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 8, 2011
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 8, 2014
BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 31, 2023
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
AMISTEM H, HA COATED STEM SIZE 5 STD
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code LZO·September 20, 2017
VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
FDA Enforcement
Class II
·Terminated·VGI Medical, LLC·June 13, 2018