25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·January 15, 2024
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
ELMED
FDA UDI
ELMED INCORPORATED·00842180160996·PRISM CERVICAL CURETTE 10" ANGLED 90° 2, DARK BLUE
SNP®F.A.S.T. PEG DRIVER JUMBO
FDA UDI
Biomet Orthopedics, LLC·00887868025839·
DENTAPORT ZX
FDA 510(k)
FDA Class 1
·Dental
ADVANCE CS CORONARY SINUS INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 10, 2008
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·August 25, 2011
TITANIUM ROOF PILE SCREW 45MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDJ·July 17, 2013
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·February 3, 2017
ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·March 10, 2017
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Technologies Ltd.·November 27, 2024