14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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M. Blue Adjustable Shunt System
FDA 510(k)
FDA Class 2
·Neurology
RANDOX METHAMPHETAMINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code FOZ·November 1, 2023
TPRLOC COCR CMTD STM T1 12.5MM
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDI·March 23, 2026
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LZO·November 24, 2025
MERGE CARDIO
FDA Adverse Event
Malfunction
·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 27, 2013
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 11, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
BD INSYTE AUTOG BC PNK 20GA X 1.16IN
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2023
REVITAN, DISTAL PART, CURVED, UNCEMENTED, 24/200
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWY·July 20, 2023
CMK MOD 12/14 SZ202 L130
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·January 8, 2026
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