16 results
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34ms
·
Sources: EU EUDAMED, US FDA
ARTELON SPACER CMC-1
FDA 510(k)
FDA Class 2
·Orthopedic
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 70mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009781·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867521964·Cannulated Cancellous Screw, 7.0x70mm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175290·Z-Rod, Dia. 5.5mm, Co-Cr, 70mm
NA
FDA UDI
ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311152·
FLOCATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRAPAK NEHA
FDA 510(k)
FDA Unclassified
·Unknown
SERIES A PAT W/WR THN 28 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·October 6, 2006
CORDLESS DRIVER
FDA Adverse Event
Malfunction
·STRYKER·Product code HTW·April 1, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 5, 2011
CODMAN SURGICAL PATTIE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code HBA·May 7, 2008
NEO IRIS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·November 5, 2024
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 30, 2022
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018