10 results · 19ms · Sources: EU EUDAMED, US FDA

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PACEART SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LATEX SURGEONS GLOVE (POWDERED)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019

BD INTEGRA¿ 3ML SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·August 10, 2015

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·March 27, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 18, 2011

FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·March 27, 2008

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018