16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUMI ManipulatOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Philips
FDA UDI
Sbo Hearing A/S·05714464003372·HEARLINK 9010 BTE PP, 2.4G NFM DPB TP
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514360·
PROFYLE
FDA UDI
Stryker GmbH·07613153160373·Screwdriver Blade
ELMED
FDA UDI
ELMED INCORPORATED·00842180150775·BROWN-BAHNSON FORCEPS, BAYONET, 6", (15CM)
SOPRO595 INTRA ORAL CAMERA
FDA 510(k)
FDA Class 1
·Dental
ETHEREA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
ULTRATHANE COPE NEPHROURETEROSTOMY SET
FDA Adverse Event
Injury
·COOK INC·Product code LJE·March 29, 2019
STYLUS STANDARD HANDPIECE
FDA Adverse Event
Malfunction
·DENTSPLY PROFESSIONAL·Product code EFB·October 27, 2014
CERALAS
FDA Adverse Event
Other
·BIOLITEC·Product code GEX·March 20, 2007
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013
BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 9, 2023
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
FDA Enforcement
Class II
·Terminated·Philips North America Llc·December 29, 2021
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023