13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801035296·Rib Derotation Set - Hook, Left
ZOLL PAD WITH CPR AID
FDA 510(k)
FDA Class 3
·Cardiovascular
MINICAM
FDA 510(k)
FDA Class 1
·Dental
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·November 1, 2023
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR CLONMEL·Product code NIQ·June 15, 2010
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·March 26, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·March 17, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 26, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·February 6, 2023
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIO·July 17, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014