20 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
FDA 510(k)
FDA Class 2
·Hematology
INPULSE DENTAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
FDA 510(k)
FDA Class 2
·General Hospital
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011
M-H HA/PC 11X160MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
M-H SOLID SHELL HA/PC DIA54MM LN24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·March 1, 2016
MALLORY-HEAD SHORT FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·July 28, 2017
MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·August 11, 2016
GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007
VANSONNENBERG¿ SUMP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FFA·March 26, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 8, 2011
MLRY-HD XR LAT POR FMRL 8MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020
BACT/ALERT I NST 100 BTLS - 259785
FDA Adverse Event
Malfunction
·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024
M-H HA/PC 12X165MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017