9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BACTICARD STREP
FDA 510(k)
FDA Class 1
·Microbiology
SeaSpine Spacer System - Ventura
FDA UDI
Seaspine Orthopedics Corporation·10889981089139·Ventura Implant/Trial Caddy, 9mm x 28mm
ZAVATION
FDA UDI
Zavation LLC·00842166190610·Polyaxial Reduction Screw 3.5x14
XCAGE INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CODA CX1 MOTION ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 29, 2013
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·December 20, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021