22 results
·
30ms
·
Sources: EU EUDAMED, US FDA
DEFENDO Bronchoscopy Suction Valve
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088521·
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106051·DYSON-COLIBRI FORCEPS SHORT
SILBRONCHO DOUBLE LUMEN TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
ULTRA SEAL STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 20, 2017
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·August 1, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 25, 2017
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 17, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·March 21, 2017
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014
REUNION TSA - X3 PEGGED GLENOID - SIZE 52
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code HSD·June 7, 2013
UNICEL DXC 600 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·June 24, 2011
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 26, 2017
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014