11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENTAX Medical ED-3490TK Video Duodenoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568106·CoRoent Ant TLIF PEEK, 9x12x28mm 0°
Sklar®
FDA UDI
SKLAR CORPORATION·10649111299728·RUSSIAN TISSUE FORCEP 8"
CYPHER DICOM PRINT SOLUTION
FDA 510(k)
FDA Class 2
·Radiology
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
FDA 510(k)
FDA Class 2
·Dental
METER C - OT BASIC ENHANCED
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code CFR·February 5, 2002
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code NVN·January 13, 2014
INVIVO CORPORATIN EXPRESSION MRI PATIENT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·INVIVO CORPORATION·Product code MWI·May 30, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
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