12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BETA HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
T2 - NAIL HOLDING SCREW, TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·June 23, 2025
Corvocet Biopsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
FDA Adverse Event
Injury
·MPRI·Product code NVY·February 9, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 8, 2011
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·July 23, 2014
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026