10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIDI
FDA UDI
TIDI PRODUCTS, LLC·00618125114894·Sterilization Wrap
HA Bone Screws
FDA UDI
ORTHOFIX SRL·18032568862027·OSTEOTITE SELF-DRILL.220/50 MM BONE SCREW THREA...
ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
FDA 510(k)
FDA Class 2
·General Hospital
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
FDA 510(k)
FDA Class 2
·Cardiovascular
BREEZE2 TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·December 15, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
WAVELIGHT FS200 FEMTOSECOND LASTER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·July 17, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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