8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESG-1 ELECTROSONOGRAM (ESG-1)
FDA 510(k)
FDA Class 1
·Dental
artegral
FDA UDI
Merz Dental GmbH·D7091970116·anteriors; shade A4; mould CL
POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Thermi Injectable RF Electrodes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·February 15, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2011
CENTRAX DURATION 26MM X 41MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·July 31, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021