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

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Airdog X8 Air Purifier (KJ800F-X8)

FDA 510(k)
FDA Class 2 ·General Hospital

MODIFICATION TO NXSTAGE SYSTEM ONE

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

STREAMLINE TL SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD ULTRA-FINE¿ INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·July 12, 2018

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

BD ULTRA-FINE¿ INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·December 11, 2018

55MM NTLC SELECTABLE RELOAD

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011

MINILINK TRANSMITTER

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·November 10, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 22, 2013

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·February 25, 2026