12 results · 22ms · Sources: EU EUDAMED, US FDA

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Medilas H RFID Laser Fibers

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

NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT

FDA 510(k)
FDA Class 2 ·Immunology

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

FDA 510(k)
FDA Class 2 ·General Hospital

ECOLAB

FDA Adverse Event
ECOLAB·Product code LHC·April 6, 2016

WARMER DRAPE

FDA Adverse Event
Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·February 12, 2016

PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·July 17, 2015

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 8, 2014

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Malfunction ·MPRI·Product code NVN·June 7, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011

WARMER DRAPE

FDA Adverse Event
Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·February 18, 2016

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023