10 results · 20ms · 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.

BONART ART-L5 LED CORDLESS CURING LIGHT

FDA 510(k)
FDA Class 2 ·Dental

MTG - MINITUB HEATED STAGE SYSTEMS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ISOLA SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,DOM

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·March 18, 2022

MINICAP TRANSFER SET

FDA Adverse Event
Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 29, 2013

UNKNOWN LONGEVITY LINER

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·May 3, 2011

SOEHENDRA LITHOTRIPSY CABLE

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code LQC·July 25, 2008

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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