9,333 results · 38ms · Sources: EU EUDAMED, 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