13 results
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27ms
·
Sources: EU EUDAMED, US FDA
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045449·Barrel Shaver, 10mm
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045456·Barrel Sizer, 10mm
FORMATK MAGMA PLATFORM LASER
FDA Adverse Event
Injury
·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019
VIBERECT PENILE VIBRATORY STIMULATION DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FORMATK MAGMA PLATFORM
FDA Adverse Event
Malfunction
·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020
DEPUY ASR XL FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 24, 2014
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 24, 2011
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 23, 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