18 results · 20ms · Sources: EU EUDAMED, US FDA

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MRCAT

FDA 510(k)
FDA Class 2 ·Radiology

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741514350·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674151435060·

ProLift

FDA UDI
Life Spine, Inc.·00190837137991·

ProLift

FDA UDI
Life Spine, Inc.·00190837086190·

UMBILI-CATH

FDA Adverse Event
Malfunction ·UTAH MEDICAL PRODUCTS·Product code FOS·January 7, 2016

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

FDA 510(k)
FDA Class 2 ·Immunology

IMIX PANORAD AND SOMARAD

FDA 510(k)
FDA Class 2 ·Radiology

BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MLA·December 29, 2022

AMISTEM H HA COATED STD STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 9, 2019

A-C RAPID-D/LINK

FDA Adverse Event
Malfunction ·FRESENIUS KABI DEUTSCHLAND GMBH·Product code FPA·June 7, 2013

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 6, 2011

ACS HI-TORQUE IRON MAN GUIDE WIRE

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·September 5, 2008

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

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014

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