101 results · 21ms · Sources: EU EUDAMED, US FDA

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Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600191·Mand. 2. Molar band W-Fit left 19

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600190501·Mand. 2. Molar band W-Fit left 19

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600190051·Mand. 2. Molar band W-Fit left 19

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600190101·Mand. 2. Molar band W-Fit left 19

RETRACTOR ARM CLAMP

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

APEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·June 19, 2009

APEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·June 8, 2009

MAVERICK2 MONORAIL PTCA CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·April 19, 2007

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 26, 2017

ACTIVA PC+S

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 9, 2018

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 29, 2018

APEX MONORAIL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LOX·April 20, 2009

MED-EL MAESTRO COCHLEAR IMPLANT SYS

FDA Adverse Event
Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 29, 2014

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 13, 2013

SUPER POLIGRIP ORIGINAL CREAM

FDA Adverse Event
Other ·GLAXOSMITHKLINE·Product code KOL·January 5, 2011