10 results · 31ms · Sources: EU EUDAMED, US FDA

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TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

COLLES C SERIES FRAME STERILE PACK

FDA 510(k)
FDA Class 2 ·Orthopedic

PACIFIC HEMOSTASIS REFERENCE EMULSION

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015

25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
UNKNOWN·Product code ITJ·September 16, 2014

VASOVIEW HEMOPRO 2 EVH SYSTEM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·April 12, 2011

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