13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PTFE Super Sheath Introducer 2.1
FDA 510(k)
FDA Class 2
·Cardiovascular
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532460·Crossbar Acetabular Reamer - 46mm
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·October 9, 2017
IPLAN RT
FDA 510(k)
FDA Class 2
·Radiology
PATIENT MATCHED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CONTOUR
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·September 19, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2015
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·December 8, 2022
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 8, 2013
SMITH & NEPHEW
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·July 1, 2011
BIOLOX CERAMIC MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MRA·September 5, 2008
MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DTE·February 10, 2021
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023