10 results · 28ms · Sources: EU EUDAMED, US FDA

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Blue Eye

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

SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

SMARTGRAFT 30 SYSTEM

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

BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 17, 2021

LIGASURE HS MAX DISP ELECT/CORD

FDA Adverse Event
Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·September 2, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·November 20, 2008

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013

Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080

FDA Enforcement
Class II ·Ongoing·Abbott·April 30, 2025

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018