13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030348·WONDER MODEL MAMAN 140 SHEER, SIZE M, NERO, GRA...
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820303480·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
COLORADO MICRODISSECTION NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E.N.S.I. RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·March 28, 2013
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZL·March 21, 2011
RINGLOC BI-POLAR CUP
FDA Adverse Event
Malfunction
·BIOMET, INC.·Product code JDI·April 15, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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