78 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F, 1.5-4.5mm)
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F)
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F, 1.5-4.5mm)
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F)
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F, 1.5-4.5mm)
Scaffold, Dissection Repair
FDA Pre-Market Approval
FDA Class 3
·Tack Endovascular System (4F)
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235817·PLATE 6190027 ANTERIOR CERVICAL 27.5MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000868055·PLATE 6190027 ANTERIOR CERVICAL 27.5MM
DemarkQ
FDA UDI
Light Tree Ventures Europe B.V.·08720299044227·The DemarkQ is an Over-the-Counter (OTC) device...
Q-Rejuvalight Pro Facewear
FDA UDI
Light Tree Ventures Europe B.V.·08719327598719·
Q-Rejuvalight Pro Facewear (Model: P19-0023)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUCLEUS 22
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code MCM·May 18, 2025
SteriStay
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THERASCREEN KRAS RGQ PCR KIT
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 21, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 18, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
FDA Pre-Market Approval
FDA Class 3
·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL