15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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