20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331155765·adson-micro thumb forceps, tissue forceps, 1x2 ...
LITE PELVIC FLOOR REPAIR KITS
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
RADIAL JAW¿ 3
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·July 23, 2011
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 23, 2008
MAX PRI TIB BRNG 14X79/83
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 1, 2019
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 4, 2024
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 6, 2024
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 25, 2025
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 21, 2021
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 21, 2026
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 17, 2021
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 13, 2022
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 16, 2025
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 20, 2022
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 4, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024