17 results
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29ms
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Sources: EU EUDAMED, US FDA
DATA MASTER PERFUSION MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001388·artVeneer life lower anteriors, UBM, C3
MLX 300W XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code FCW·May 23, 2019
Diagon
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO0013880·"Off-Set, Bi-Convex, 12mm x 34mm x 18mm, Obliq...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRASIM CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Death
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 20, 2019
SUNBEAM SERIES 001388-800 WARM MIST VAPORIZER
FDA Adverse Event
Injury
·JARDEN CONSUMER SOLUTIONS / SUNBEAM PRODUCTS, INC.·Product code KFZ·May 2, 2019
2520274-2013-01435
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 13, 2013
LIGACLIP*MCA MED APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·February 25, 2011
NONE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 23, 2008
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·November 4, 2015
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024