24 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEFLECTING URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120306421·Diamond, cone pointed, medium grit
Sims Malleable Curette
FDA UDI
MEDGYN PRODUCTS, INC.·M803030642·Sims Malleable Curette #0
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
PLACEMENT-PLUS
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOBLAST
FDA Adverse Event
Injury
·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013
C21617 DE LIFE SYSTEMS $PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 2, 2013
NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 18, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 15, 2008
CP82200 I MIRANDOLA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012
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
CP85341 FR PARIS
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
EMORY/CL/KNNSTN ATLANTA GA1
FDA Adverse Event
Other
·SORIN GROUP USA·Product code DWF·August 19, 2010
DUKE UNIV DURHAM NC 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016
COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016
REVOLUTION CENTRIFUGAL BLOOD PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code KFM·July 20, 2018