BEUDAMED
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    EXELINT ALUMINUM HUB BLUNT NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vapotherm

    FDA UDI
    VAPOTHERM, INC.·00841737105497·Medipower Battery Module

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·08033201841273·HALF RING INTERNAL DIAMETER 220MM SS

    Tasso+

    FDA UDI
    Tasso Inc.·00850038691004·

    CIV-Flex™ Transducer Cover

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103145·Non-sterile (17.8 x 147cm) telescopically-folde...

    MED-RX

    FDA UDI
    Canadian Hospital Specialties Limited·00628725003719·I.V. ADMINISTRATION EXTENSTION SET, COILED

    MED-RX

    FDA UDI
    Shenzhen Boon Medical Supply Co., Ltd.·06938327901332·1-60"(1500mm) Coiled Tubing with Check Valve(DE...

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 1, 2019

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 31, 2022

    LUTE VLC; CORE VLC

    FDA 510(k)
    FDA Class 2 ·Dental

    HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250

    FDA 510(k)
    FDA Class 2 ·Dental

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981308254·Rotary Scraper/Dilator, 9mm w/ Depth Grooves

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP

    FDA Adverse Event
    Malfunction ·MICROLINE SURGICAL, INC.·Product code GCJ·May 3, 2013

    NATURALYTE

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 1, 2021

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020