12 results · 21ms · Sources: EU EUDAMED, US FDA

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GLOBALCARDIO

FDA 510(k)
FDA Class 2 ·Cardiovascular

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450506349·

HIGH TIBIAL OSTEOTOMY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SNOWPOST, SNOWLIGHT

FDA 510(k)
FDA Class 1 ·Dental

QUICK-CORE ULTRASOUND BIOPSY NEEDLE

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FCG·September 4, 2018

UNKNOWN ORTHOSIS

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

PROMUS ELEMENT ¿

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 20, 2013

UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 10, 2011

PERMACLIP DISPOSABLE CARTRIDGE 10MM CLIPS

FDA Adverse Event
Injury ·DESIGN STANDARDS CORP·Product code GDO·March 13, 2008

LOGIC CR FEMORAL CEM, LEFT, SZ 6

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 6, 2024

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