16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
DATEX-OHMEDA NETWORK AND CENTRAL
FDA 510(k)
FDA Class 2
·Cardiovascular
BN PROSPEC SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·April 25, 2022
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·April 25, 2022
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
FDA Recall
Terminated
·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
ACUITY CENTRAL MONITORING
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 13, 2013
ECHELON*FLEX60 ARTICULATIN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·February 28, 2011
COMPACT MONITOR DISPLAY
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 26, 2008
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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.·November 2, 2016