10 results · 23ms · Sources: EU EUDAMED, US FDA

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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