17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENAMEL PACK
FDA 510(k)
FDA Class 2
·Dental
artegral life
FDA UDI
Merz Dental GmbH·D7091993659·anteriors; shade BL4; mould UBIS
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
FDA 510(k)
FDA Class 2
·Cardiovascular
iTero Element 5D
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2015
SINGLE SITE PORT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 7, 2013
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
DURAL ALPHA INSERT W RIM II/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·March 12, 2019
DURASUL, ALPHA INSERT, HOODED, II/32
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LPH·September 28, 2018
METASUL, ALPHA INSERT, JJ/28
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·February 4, 2019
DURASUL, ALPHA INSERT, KK/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
NASAL-AIRE
FDA Adverse Event
Malfunction
·INNOMED TECHNOLOGIES·Product code BYE·January 6, 2003
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·November 10, 2025
COCR HEAD 32/ 0 'M' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·June 4, 2019
DURASUL, ALPHA INSERT, LL/36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 29, 2019
DURASUL, ALPHA INSERT, HOODED, KK/32
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code LPH·June 15, 2018
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024