294 results · 29ms · Sources: EU EUDAMED, US FDA

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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