11 results · 28ms · 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.

DIAMOND-5A/6A/8A

FDA 510(k)
FDA Class 2 ·Radiology

BINAX NOW COVID-19 AG CARD KIT 40T EUA

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023

BINAX NOW COVID-19 AG CARD KIT 40T EUA

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023

BINAX NOW COVID-19 AG CARD KIT 40T EUA

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023

BINAX NOW COVID-19 AG CARD KIT 40T EUA

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023

STERISPINEPS PEDICLE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY

FDA 510(k)
FDA Class 1 ·General Hospital

INFINITI VISION SYSTEM

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 27, 2011

ADVIA 1800

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 27, 2013

ACCU-CHEK TENDER INFUSION SET

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·October 7, 2008

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