26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fiji Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111135507·CARROLL ARTERY FORCEPS 3.5"
Symmetry Mixter
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056837·Symmetry® Forceps, Mixter Right Angle, w/Serrat...
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·January 16, 2018
MIRADA XD
FDA 510(k)
FDA Class 2
·Radiology
FIDELITY 200 CARDIAC EVENT RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
IGG ANTIBODIES TO RUBELLA VIRUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFX·August 26, 2013
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·May 11, 2022
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 7, 2016
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·January 25, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LNQ·September 22, 2008
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·August 9, 2023
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020