18 results · 24ms · Sources: EU EUDAMED, US FDA

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AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ComfortGel Blue

FDA UDI
Respironics, Inc.·00606959043886·ComfortGel Blue Full Mask, Medium, Japan

KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

35/CD CINECONVERTER

FDA 510(k)
FDA Class 2 ·Radiology

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·November 15, 2023

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·November 10, 2023

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·November 10, 2023

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 9, 2011

CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·July 22, 2008

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·November 15, 2023

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·November 19, 2024

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·November 19, 2024

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·November 19, 2024

MULTI-LINK RX VISION CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAF·December 21, 2012

HI-TORQUE WHISPER MS GUIDE WIRE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code DQX·December 20, 2012

BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD SUZHOU (MDS)·Product code FOZ·February 24, 2025

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016