18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181514·Integra® Jarit® Laparatomy Ring, 2"
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014799·Screw Assy REset Solid 5.0X30mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014775·Screw Assy REset Solid 5.0X20mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014782·Screw Assy REset Solid 5.0X25mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014805·Screw Assy REset Solid 5.0X35mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014829·Screw Assy REset Solid 5.0X45mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014812·Screw Assy REset Solid 5.0X40mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014836·Screw Assy REset Solid 5.0X50mm Gen 3
FUSTAR STEERABLE INTRODUCERS
FDA 510(k)
FDA Class 2
·Cardiovascular
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 27, 2006
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013
SYNCRHOMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 29, 2008
ASAHI GLADIUS MG14 PV ES
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020