294 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
artegral
FDA UDI
Merz Dental GmbH·D7091970056·anteriors; shade A2; mould UIM
COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code MCM·February 13, 2026
COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·February 13, 2026
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·May 24, 2013
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PGQ·July 4, 2016
NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code PGQ·August 1, 2016
ROTAPRO
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MCX·October 15, 2025
ROTABLATOR?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·May 5, 2025
ROTABLATOR?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·April 4, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 20, 2013
LIFELINE VIEW AED
FDA Adverse Event
Death
·DEFIBTECH, LLC·Product code MKJ·January 20, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 24, 2020
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR(R)
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625