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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BonAlive Granules

FDA 510(k)
FDA Class 2 ·Orthopedic

VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM

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

CORONIS 5MP HD, MODEL MDMG 5121

FDA 510(k)
FDA Class 2 ·Radiology

VASO VIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019

VASOVIEW HEMOPRO 2

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

ACT ARTIC E1 28MM ID X 38MM OD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LPH·June 26, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 28, 2011

HEMOPRO 2 ADAPTOR

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018