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

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LEva Pelvic Digital Health System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

OT VERIO FLEX METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2018

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORP·Product code LZG·February 20, 2009

INSYTE AUTOG BC PNK 20GA X 1.0IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·November 30, 2023

INSYTE AUTOG BC PNK 20GA X 1.0IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·November 30, 2023

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 20, 2023

BD INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023

BD INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023

MERGE CARDIO

FDA Adverse Event
Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

QUICKFLEX MICRO LV LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC CRMD·Product code NIK·January 11, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

PINNACLE MTL INS NEUT36IDX56OD

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 27, 2013

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018