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

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CHARISMA -- MODIFIED

FDA 510(k)
FDA Class 2 ·Dental

LP Low Profile

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746088995·DB BKT LP LR CUSP 018 T=0 A+3 R=0

LEONE SPA

FDA UDI
LEONE SPA·08033707066811·ELASTIC LIGATURES TRANSP 1,3mm

Obtura Spartan

FDA UDI
Young Innovations, Inc.·00843471100936·EMS Threaded Tip KiS-3E

Obtura Spartan

FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020442·EMS Threaded Tip KiS-3E

COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

SWIFT AIR

FDA 510(k)
FDA Class 2 ·Anesthesiology

UNKNOWN DEPUY ASR SLEEVE

FDA Adverse Event
Malfunction ·DEPUY INTL., LTD. - 8010379·Product code KXA·April 3, 2014

ACRYSOF TORIC

FDA Adverse Event
Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 6, 2013

JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

FDA Adverse Event
Injury ·ALLERGAN·Product code LMH·June 20, 2014

ENRHYTHM DR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 17, 2010

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 28, 2013

APPLIANCE, FIXATION, NAIL

FDA Adverse Event
Injury ·SYNTHES USA·Product code KTT·April 21, 2017

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021