19 results · 22ms · 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.

GE DELTA SOFTWARE OPTION FOR MRI

FDA 510(k)
FDA Class 2 ·Radiology

Verteloc Lumbar Cage

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129309·

Arlington PLIF Cage

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215026301·

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME

FDA 510(k)
FDA Class 2 ·Cardiovascular

MINI SHOPPER

FDA 510(k)
FDA Class 2 ·Physical Medicine

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

RAPIDPOINT 405

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS,·Product code CHL·March 25, 2013

NC QUANTUM APEX BALLOON CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 28, 2011

AED PRO

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008

STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·April 1, 2025

BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 3, 2020

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013