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

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AMS SMART SLING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ARM AUTOMATIC REPROCESSING MACHINE

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

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 6, 2016

CONNECTA PLUS3 RED

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·January 18, 2021

LIQUID INFANT HEEL WARMER

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code MPO·April 12, 2013

3D KNEE SYSTEM

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code HSH·June 20, 2008

ZIMMER M/L TAPER FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LPH·April 13, 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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015