11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pediatric Nailing Platform Tibia
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111162695·SKLIT SKLCT OP SCIS CRV SB 5.5
ELMED
FDA UDI
ELMED INCORPORATED·00842180169777·PRISM CERVICAL CURETTE, 10," REVERSE ANGLE 0, G...
SURSHIELD SAFETY WINGED INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
TREZ_HD
FDA 510(k)
FDA Class 2
·Neurology
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
REMB SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 25, 2011
X SERIES
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 5, 2013
CARELINK CONNECT APP ANDROID
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·November 8, 2023
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025