36 results · 23ms · Sources: EU EUDAMED, US FDA

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PlaDuo System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HHM

FDA UDI
Oticon A/S·05707131351739·G300 SC, BTE PP 13 2.4G 105 C093 HHM

N/A

FDA UDI
HANS RUDOLPH, INC.·00874750005642·QUEST LG REPLMNT FACE PC A7031

CODMAN

FDA UDI
Cerenovus, Inc.·10886704001935·CODMAN SLIM-LINE Aneurysm Clip Bayonet Blade Le...

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856063297·Ti ILIAC BONE SCREW ASSY, 8.5mm X 35mm X 30°

Zodiac

FDA UDI
ALPHATEC SPINE, INC.·00844856063280·TI ILIAC BONE SCREW ASSY, 8.5MM X 35MM X 15°

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY

FDA 510(k)
FDA Class 2 ·Cardiovascular

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 20, 2017

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·July 20, 2023

VALIANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 31, 2019

TALENT AAA STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 31, 2019

TALENT TAA STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 31, 2019

ENDURANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 31, 2019

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·October 27, 2014

ACROBAT-I STABILIZER

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

POUNCE VENOUS THROMBECTOMY SYSTEM

FDA Adverse Event
Injury ·SURMODICS INC·Product code QEW·May 16, 2024

PFC*SIGMA/OV/DOME PAT 3PEG,35

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·December 21, 2018

Colonoscope, Model Number PCF-H190L.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024