14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BTL-785F
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NARVAL CC
FDA 510(k)
FDA Class 2
·Dental
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 8, 2013
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 15, 2022
OMNIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026
THORACOPORT 11.5MM TROCAR
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·October 7, 2008
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·June 25, 2013
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·July 21, 2011
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·October 6, 2025
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 27, 2024
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·February 27, 2024
TIBIAL INSERT A-14,CONSTRAINED
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JWH·February 6, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024