17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MagXtract Collection Tube
FDA 510(k)
FDA Class 2
·Microbiology
NA
FDA UDI
Synthes GmbH·10886982151872·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
Origin Size 13 Template
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074760·
ELECSYS MYOGLOBIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INDWELLING FECAL MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 24, 2008
COMPREHENSIVE SHOULDER INSTRUMENT PRIMARY SHOULDER STEM INSERTER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXH·August 15, 2011
ATLAS OBS 10/25/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 8, 2013
PROTECTOR P15J
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·March 22, 2024
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Enforcement
Class II
·Terminated·Tenex Health Inc·May 14, 2014
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024