13 results · 22ms · Sources: EU EUDAMED, US FDA

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Electrical Stimulator System

FDA 510(k)
FDA Class 2 ·Neurology

SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

FDA 510(k)
FDA Class 3 ·Cardiovascular

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·July 1, 2014

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 25, 2011

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014

ADEL OBS 6/04

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 18, 2013

LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code HSB·June 30, 2014

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

BD VERITOR¿ PLUS ANALYZER

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025

Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

FDA Enforcement
Class II ·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019