82 results · 26ms · Sources: EU EUDAMED, US FDA

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K162309

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

StealthStation S8 System Platforms and StealthStation Cranial Software

FDA 510(k)
FDA Class 2 ·Neurology

BI-METRIC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304251984·

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·November 7, 2021

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·November 7, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 4, 2021

ID NOW COVID 19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 8, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 7, 2021

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 12, 2021

KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105

FDA 510(k)
FDA Class 1 ·Physical Medicine

DIGITAL RADIOGRAPHY

FDA 510(k)
FDA Class 2 ·Radiology

ASR UNI FEMORAL IMPL SIZE 51

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·July 7, 2011

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

PROXIMATE ILS CURVED CIR STAPL

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 8, 2008

M2A TAPER 37/28MM LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2016

M2A MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER MINUS 6 MM NECK

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2016

M2A/C2A ACETABULAR SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDL·April 21, 2017

M2A/C2A ACETABULAR SYSTEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDL·April 21, 2017

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

FDA Recall
Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·November 5, 2018