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

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Initial LiSi Press

FDA 510(k)
FDA Class 2 ·Dental

McKesson

FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479271562·CLEANER, GERMICIDE SPRAY PLUS MCKESSON 24OZ (6...

SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

FDA 510(k)
FDA Class 2 ·Dental

5TH METATARSAL FRACTURE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 1, 2016

ABL800 FLEX ANALYZER

FDA Adverse Event
Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·April 20, 2023

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 11, 2017

PROTECTA XT DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

OCTRODE LEAD, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

HEMOSIL HIT-AB(PF4-H)

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·February 18, 2015

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

FDA Recall
Terminated ·ConMed Corporation·Product code GEI·May 8, 2014

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023