15 results · 29ms · 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.

ET III Bio-SA Fixture System

FDA 510(k)
FDA Class 2 ·Dental

Masel

FDA UDI
Ortho Organizers, Inc.·00190707040956·Choice™ Jaraback w/ Cutter

ProLift

FDA UDI
Life Spine, Inc.·00190837105914·Static Expandable Cage Trial, 12mm x 28mm x 10m...

LENSX LASER SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016

BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 11, 2018

PENUMBRA SYSTEM MAX ASPIRATION TUBING

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

IN TOUCH ZU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013

COMPOSIX MESH E/X

FDA Adverse Event
Injury ·DAVOL INC·Product code FTL·June 29, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

Precise Digital Accelerator Delivery of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 26, 2012

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 20, 2013

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014