11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ACE PERCUTANEOUS 3MM HALF-PINS
FDA 510(k)
FDA Class 2
·Orthopedic
GC Initial™
FDA UDI
Gc America Inc.·J0228750131·GC Initial™ IQ/Power Frame Modifier-Zr PFM-4, 10g
GC Initial™
FDA UDI
Gc America Inc.·15400556710132·GC Initial™ IQ/Power Frame Modifier-Zr PFM-4, 10g
Arthrex®
FDA UDI
ARTHREX, INC.·00888867266063·DRL BIT, 3.7 MM, CANN.
Reprocessed 3.7mm Cannulated Drill Bit
FDA UDI
SURETEK MEDICAL·B390AR8750131·
RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO
FDA 510(k)
FDA Class 1
·Hematology
QUANTIMETRIC PLUS SUPPORT PACK
FDA 510(k)
FDA Class 2
·Immunology
UNKNOWN M2A HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 16, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·December 17, 2012
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021