16 results · 22ms · Sources: EU EUDAMED, US FDA

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BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
STRYKER CORPORATION·07613327056570·Insert, Right-Angle Dissector (Long Jaw)

POWER TEK II

FDA 510(k)
FDA Class 2 ·Orthopedic

SPL-50 SPIROLYSER

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

PINNACLE MTL INS NEUT36IDX60OD

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·April 26, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 6, 2011

VISTA BRITE TIP GUIDING CATHETERS

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code DQY·July 22, 2008

SUPERA SELF-EXPANDING STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code NIP·March 31, 2021

ARCHITECT CYCLOSPORINE REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR·Product code DQX·March 31, 2021

ARCHITECT CYCLOSPORINE REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

ARCHITECT CYCLOSPORINE REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

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