13 results · 19ms · 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.

RITA CLIPS FOR INFUSION PUMPS

FDA 510(k)
FDA Class 2 ·General Hospital

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING

FDA 510(k)
FDA Class 2 ·Radiology

VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM

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

VERTE-STACK K030736, K041197

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

VC10 PUMP, 115V

FDA Adverse Event
Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

BD ULTRA FINE¿ INSULIN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 18, 2018

ARCHITECT C8000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code CGZ·April 2, 2013

EON C 16-CHANNEL IPG

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011

CLINICAL INFORMATION CENTER

FDA Adverse Event
Malfunction ·GE HEALTHCARE·Product code DRT·April 17, 2008

Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

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