26 results · 23ms · Sources: EU EUDAMED, US FDA

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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