17 results · 21ms · Sources: EU EUDAMED, 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