25 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
ReLine
FDA UDI
Nuvasive, Inc.·00195377047700·RELINE-O Trial,11mm H Ang Right L-pop
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00142006150·D3
Waterlase Laser Tips
FDA UDI
Biolase, Inc.·00647529000694·A tip kit containing 3 reusable laser tips inte...
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856023420·SS OFFSET CONNECTOR, 15MM
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856002036·OFFSET CONNECTOR ASSEMBLY 15mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694060448·TAG, SAFETY SCREW, ER
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
ARSTASIS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 7, 2012
MAXIMO VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
LANCET 33GA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMK·October 14, 2021
SENSIA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·July 1, 2013
SEEDNET CRYOTHERAPY SYSTEM
FDA Adverse Event
Death
·GALIL MEDICAL LTD.·Product code GEH·September 10, 2010
PULMONARY VALVE & CONDUIT
FDA Adverse Event
Injury
·ARTIVION, INC.·Product code MIE·November 5, 2024
RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 14, 2020
ULTRAPRO MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 21, 2019
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·August 21, 2019