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

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ARIX Cannulated Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

Plum

FDA UDI
ICU Medical, Inc.·10887787005315·LIFESHIELD, Primary PLUM Set, Orange Polyethyle...

VITA TITANKERAMIK

FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2339120·VITA TITANKERAMIK OPAQUE DENTINE, 2R2.5, 12 g

Vu a-POD™

FDA UDI
Seaspine Orthopedics Corporation·10889981041939·39x30mm Trial Rasp 12mm 8 deg

ICU MEDICAL PRIMARY PLUM SET ORANGE PE LINED

FDA Adverse Event
Injury ·ICU MEDICAL, INC.·Product code FPA·December 13, 2022

ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CRADLE PACS

FDA 510(k)
FDA Class 2 ·Radiology

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·July 6, 2020

INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·May 28, 2020

EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·November 13, 2008

ASR ACETABULAR IMPLANT 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 18, 2013

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

ALINITY I TOXO IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

FDA Enforcement
Class I ·Terminated·Animas Corporation·April 10, 2013

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023