BEUDAMED
    23 results · 37ms · Sources: EU EUDAMED, US FDA

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    POINTER PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040119690·NITINOL RIGHT FORM NATURAL ARCHWIRE .016 LOWER

    SAFE-T-FILL®

    FDA UDI
    Ram Scientific, Inc·10643351000380·SAFE-T-FILL® MicroHematocrit Capillary Tubes, 5...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306813856·DeBakey Tissue Forceps, 2.7mm, 18"(45.5cm) - 06...

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0600080·Try insert, InTess C Level 1

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0600080·Tray Insert, Lumbar Rods

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0600080·Tray Insert, Level I

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0600080·Tray Insert, Disc Prep 1

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THERMOFLEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube

    FDA Enforcement
    Class II ·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025

    18GA X 1 1/2IN BD¿ BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·August 31, 2017

    145-DEG PE 38MM CONST HUM LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 3, 2025

    LIGASURE ATLAS HANDSWITCHING 20CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·March 26, 2013

    UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·April 18, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2008

    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube

    FDA Recall
    Open, Classified ·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008