9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NextDent Denture, E-Denture
FDA 510(k)
FDA Class 2
·Dental
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
FDA 510(k)
FDA Class 2
·Dental
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MS-30®, STEM, STANDARD, CEMENTED, 10, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·July 16, 2024
ANATOMIC
FDA Adverse Event
Injury
·AMPLITUDE·Product code JWH·January 10, 2022
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 14, 2011
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014