24 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009635·Zirlux 16+ B1 100X10
TRI-CAM Dental Implant System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950027286·TRI-CAM Temporary Abutment, Engaging, 4.3 Platform
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272381·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272435·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272398·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033294420·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033294413·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272404·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272411·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033272428·
INSET 30
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 1, 2025
Phonak
FDA UDI
Phonak AG·07613275066102·Phonak Bolero Q90-P (purple transparent)
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCR REPLACEMENT SW-V GOLD COPING
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·October 19, 2017
SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 8, 2020
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KPE·March 19, 2013
UNKNOWN DEPUY SIZE 4 8MM TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 4, 2011
PFC SIGMARP STB TB IN 3 17.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·March 11, 2008