14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T-SCIENTIFIC T-PAD
FDA 510(k)
FDA Unclassified
·Unknown
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
TruForm
FDA UDI
Rmo, Inc.·00885797099860·MN 2ND BI BD KT N/L R/L 176
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120303341·Diamond, medium grit
IMPACT MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STICK NET
FDA 510(k)
FDA Class 2
·Dental
BLAKE DRAIN
FDA Adverse Event
Injury
·ETHICON, INC.·Product code KOG·April 2, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·April 16, 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