22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756611671·Shoulder Immobilizer
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649569·INTREPED 10x12 implant
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109060·HA PEEK EVOS Straight, ,12mmx11mmx 30mm , FLAT ...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321110120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311110120·
Super Bypass
FDA UDI
TAKAYAMA INSTRUMENTS INC.·04580036674056·SuperBypass SI system Tip, 110mm, 1.2mm [3.6Fr]...
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046797·
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
BD SPINAL NEEDLE QUINCKE TYPE POINT
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·July 17, 2023
BD® QUINCKE SPINAL NEEDLE 27G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code BSP·January 19, 2023
BD PHASEAL¿ INJECTOR LUER LOCK N35
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 17, 2022
ACCELERATOR A3600
FDA Adverse Event
Malfunction
·INPECO SA·Product code JQP·December 20, 2024
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·May 14, 2013
ENTERPRISE 8000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MEDICAL BEDS DIVISION·Product code FNL·April 14, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·August 11, 2008
PFM PICC II
FDA Adverse Event
Malfunction
·PFM MEDICAL, INC.·Product code LJS·November 29, 2012
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024