15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565273·CoRoent Ant TLIF PEEK, 13x12x28mm 8°
Oticon
FDA UDI
Oticon A/S·05707131257918·H16, MINIBTE 312 WL 85 DBL
MICRO VASCULAR NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075900·MICRO VASCULAR NEEDLE HOLDER TUNGSTEN CARBIDE S...
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Orthopedic
JIAJIAN TENS
FDA 510(k)
FDA Class 2
·Neurology
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 29, 2013
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·June 13, 2008
ANGLED SABER PORTMAN CHUCK
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·June 11, 2011
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 30, 2024
IMP TM 6.0MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 29, 2023
TRULIANT TIB IMP CRC INSERT SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 23, 2024
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023