9,333 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GUM DEEP CLEAN COMPACT SOFT TOOTHBRUSH
FDA Adverse Event
Malfunction
·SUNSTAR AMERICAS INC.·Product code EFW·September 14, 2023
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code MDS·March 28, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 20, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 13, 2012
ROSA SURGICAL DEVICE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·April 10, 2017
MG II TOTAL KNEE SYSTEM TIBIAL ARTICULAR SURFACE ANTERIOR CO
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HRY·May 17, 2002
FOCUS DISPOSABLE CONTACT LENS
FDA Adverse Event
Injury
·CIBA VISION CORP.·Product code LPM·December 4, 1996
OPTIFREE
FDA Adverse Event
Injury
·ALCON LABORATORIES, INC.·Product code LPN·December 4, 1996
ENO
FDA Adverse Event
Malfunction
·MICROPORT CRM S.R.L.·Product code LWP·July 3, 2024
BARDEX® LUBRICATH® FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·March 5, 2018
ACCLAIM ENCORE
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 21, 2005
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·June 26, 2006
FLUENT FLUID MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code HIG·July 20, 2021
FLUENT FLUID MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code HIG·July 20, 2021
QMS EVEROLIMUS ASSAY
FDA Adverse Event
Injury
·MICROGENICS CORPORATION·Product code OUF·September 14, 2017
MICRO TORNADO HP W HANDCONTROL
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·January 23, 2020
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·March 2, 2026
FRESENIUS F5 HEMOFLOW FILTER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE·Product code KDI·January 4, 2008
LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42" X 57" SMS (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18" X 18" XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
ACUVUE ADVANCE FOR ASTIGMATISM
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·March 12, 2012