14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GSO GS1 CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOGIC FEMORAL PS POR RIGHT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·February 10, 2025
TRIATHLON P/A CR BEADED #5L
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·June 8, 2011
LOGIC CR FEMORAL POR, LEFT, SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 11, 2024
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
TRIATHION
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
TRIATHION COMPONENT
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023
LOGIC CR FEMORAL POR, RIGHT, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2019
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 26, 2023