82 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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