15 results · 27ms · 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.

VesselNavigator Rel. 1.0

FDA 510(k)
FDA Class 2 ·Radiology

ProLift

FDA UDI
Life Spine, Inc.·00190837086329·

POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)

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

BD ANGIOCATH¿ IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

PROTECTA XT CRT-D

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code NIK·June 7, 2013

6.0MM TI MATRIX POLYAXIAL SCREW

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·June 29, 2011

BD ANGIOCATH IV CATHETER 20GA 1.88IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020

ENDOSKELETON® TCS NO 6 SWIVEL DRIVER

FDA Adverse Event
Malfunction ·TITAN SPINE, LLC·Product code HXX·January 28, 2016

BD INSYTE¿ PERIPHERAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·March 20, 2018

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