26 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854006535·ULTRAPOWER BUR, ROUND (LIME) (COPPER), 2.5 MM
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365106408·
FLO ASSISTANT, MODEL 4-250-00
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDIFIX URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·February 27, 2026
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036444·STENT PED3-021-325-16 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036437·STENT PED3-021-325-14 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036451·STENT PED3-021-325-18 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036475·STENT PED3-021-325-25 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036413·STENT PED3-021-325-10 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036420·STENT PED3-021-325-12 V03 VANTAGE
PipelineTM Vantage Embolization Device with Shield TechnologyTM
FDA UDI
Micro Therapeutics, Inc.·00847536036468·STENT PED3-021-325-20 V03 VANTAGE
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code OUT·January 30, 2025
TEOSYAL RHA 4
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·November 22, 2021
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 26, 2013
54 CM BIPOLAR LEAD
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTB·February 8, 2011
HYDROTHERMABLATOR PROCEDURE SET
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MNB·March 28, 2008
MEDTRONIC IPG
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·July 20, 2021