16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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