15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Meropenem 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902317044·BD BBL™ Sensi-Disc™ Meropenem 10 µg
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
FILMLESS CLINIC
FDA 510(k)
FDA Class 2
·Radiology
EPIDOSE
FDA 510(k)
FDA Class 2
·Radiology
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
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 10, 2019
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LIMITED·Product code PFO·January 15, 2024
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 14, 2008
UNKNOWN DEPUY ASR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
12/14 ARTICUL 40MM M SPEC-2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code LPH·July 17, 2013
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022