28 results
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26ms
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Sources: EU EUDAMED, US FDA
MDI DS-DNA TEST
FDA 510(k)
FDA Class 2
·Immunology
Sledgehammer
FDA UDI
Keystone Industries·H66810004771·HC 25 lb Pwd & 4 Qt Liq Kit, Original
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116494·NobelBiocare™ Tri-Lobe-compatible NP Straight M...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092130957·NobelBiocare™ Tri-Lobe-compatible NP Straight M...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004770·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004770·
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 26, 2026
RENEGADE HI-FLO MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
STERIS AMSCO MILLENNIUM STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
FDA Adverse Event
FUTURE DIAGNOSTICS B.V.·Product code CEW·November 1, 2017
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 12, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·January 31, 2011
ZENITH FLEX AAA ENDOVASCULAR GRAFT
FDA Adverse Event
Injury
·COOK INCORPORATED·Product code MIH·February 21, 2008
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 20, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWY·November 26, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KXA·November 26, 2019
UNKNOWN HIP FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 20, 2019
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 20, 2019
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012