15 results · 19ms · Sources: EU EUDAMED, US FDA

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SELF-RECORDING ADMITTANCE METER 709

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

POWDER FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·June 11, 2024

ASR ACETABULAR CUPS 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

UNIVERSAL HANDSWITCH

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·May 28, 2015

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·July 3, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·May 9, 2024

DEMEDIOX

FDA Adverse Event
Injury ·DEMETECH CORPORATION·Product code NEW·February 23, 2024

Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·April 29, 2020

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025