19 results · 25ms · Sources: EU EUDAMED, US FDA

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VARIAN HIGH ENERGY LINEAR ACCELERATOR

FDA 510(k)
FDA Class 2 ·Radiology

7920 MASK

FDA UDI
HANS RUDOLPH, INC.·00817136020228·7920 LG ADULT M/F MASK W/2700

AUROPAL, ORDER-NO.: 2101

FDA 510(k)
FDA Class 2 ·Dental

SPIDER STANDARD AND ADVANCED

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·October 3, 2016

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

SUPERDIMENSION INREACH SYSTEM

FDA Adverse Event
Injury ·SUPERDIMENSION INC.·Product code JAK·September 17, 2014

UNKNOWN DEPUY DURALOC 56X28 10D LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 18, 2011

CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 14, 2020

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

FDA Enforcement
Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ACCOLADE DR EL MRI (Model L331)

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