23 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GRADIA
FDA 510(k)
FDA Class 2
·Dental
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001518·artVeneer life lower anteriors, UBXL, D4
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085023830·Centrifuge Tubes, 15 mL, 20 Bags x 25 Tubes
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964013940·The ENDO CARRY-ON Procedure Kit contains all of...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515008830·Sponge Bowl, 14oz 4.25" x 2"
Regenalase
FDA UDI
IPG Medical Corporation·00810071230516·Regenalase Therapy Kit, Regenalase Photobiomodu...
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918163192·Needle Counter_Red_15-Count_Foam strips_Clear t...
7L4P Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904087597·
Sonova Brand
FDA UDI
Sonova AG·07613389431667·Easy Line Remote 3.0 app
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
FDA 510(k)
FDA Class 2
·Immunology
MACROPRO GEL
FDA 510(k)
FDA Unclassified
·Unknown
DYNASTY(R) PC SHELL
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·November 12, 2012
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 14, 2018
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·January 26, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 20, 2008
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·October 23, 2025
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Enforcement
Class II
·Terminated·Sunrise Medical (US) LLC·December 11, 2013
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025