BEUDAMED
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    EUROMI EVA SP6

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bur PM2-150 80K diam Ø7.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055519938·

    GE

    FDA UDI
    Philips Ds North America LLC·00884838066267·Neurovascular Array Coil (Receive Only)

    ARGELOY PART ING (1 ao)

    FDA UDI
    ARGEN CORPORATION, THE·D818101413·Base metal alloy

    JOBST Bella Lite

    FDA UDI
    BSN MEDICAL, INC.·00035664002244·BELLA LITE 15-20 MM HG ARMSLEEVE WITH BAND SMAL...

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989027624·BRD ARCH LOFRIC.TMA UPLG 017X025 PK10

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556118·Gutta Percha Points is used to root canal filin...

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103275·Sterile needle, 14GA x 13cm with (7.6 tapered t...

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103289·Sterile needle, 14GA x 13cm with (7.6 tapered t...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383500890·Gutta Percha Points is used to root canal filin...

    POWDER-FREE VINYL EXAM GLOVE, YELLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    BD FLU+ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 2, 2021

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·May 3, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 24, 2011

    Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OXQ·December 11, 2019

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021