13 results · 21ms · Sources: EU EUDAMED, 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