10 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ACON UTI URINARY TRACT INFECTION TEST STRIPS

FDA 510(k)
FDA Class 1 ·Hematology

TIMX SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

FDA 510(k)
FDA Class 2 ·Dental

UNKNOWN STRYKER LONG GAMMA NAIL LOT#K0B4A9D

FDA Adverse Event
Injury ·STRYKER TRAUMA KIEL·Product code HSB·August 11, 2016

CP87170 DE MUENCHEN

FDA Adverse Event
Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

LIBERTY CYCLER SET, SINGLE CONN./EXT DL

FDA Adverse Event
Malfunction ·ERIKA DE REYNOSA, S.A. DE C.V.·Product code FKX·April 11, 2013

PRECISE RX NITINOL STENT

FDA Adverse Event
Death ·CORDIS DE MEXICO·Product code NIM·June 17, 2008

SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code KRA·April 19, 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