30 results · 27ms · Sources: EU EUDAMED, US FDA

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VIPI BLOCK

FDA 510(k)
FDA Class 2 ·Dental

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009854·BSTRNG 20-30 ARMSLV KNITWLT 1R NAT 1 EN

Infiniti Plus Needle Guide

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436120040·Sterile needle guide (12-18ga) with (14x147cm) ...

TRANSLUX ENERGY

FDA 510(k)
FDA Class 2 ·Dental

THERMAL CAUTERY UNIT, MODEL 150

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 2, 2024

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 25, 2022

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·February 23, 2024

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code MGB·February 13, 2024

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
Malfunction ·DOLOMITE AB·Product code ITJ·September 19, 2014

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·May 18, 2011

QUADRA-H CEMENTLESS STEM SIZE 7 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 15, 2016

UNKNOWN PEEK INTERFERENCE SCREW

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·October 20, 2022

UNKNOWN MANUAL INSTR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code NBH·October 17, 2022

XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·April 3, 2015

XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 3, 2015

XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 3, 2015

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025