24 results · 20ms · Sources: EU EUDAMED, US FDA

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SECUR-FIT MAX AND PLUS MAX HIP STEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

ACCU-CHEK ACTIVE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 10, 2013

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·March 15, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 19, 2008

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024

CE INFUSOR LV 2, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

CE INFUSOR SV 2, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024

BD PHOENIX¿ SMIC/ID-101

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026