12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PRESSURE MONITORING LINES
FDA 510(k)
FDA Class 1
·Cardiovascular
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002603·VITROS FS Diluent Pack 4
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180839·
ZONARE ULTRA ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 9, 2014
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 5, 2007
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015