BEUDAMED
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    PILOT DIODE LASER, MODEL 002-00139

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

    PIVOT Coarse Adult Variety Prophy Pack Box 100

    FDA UDI
    Preventech·D0241100143·PIVOT Coarse Adult Variety Prophy Pack Box of 1...

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517177346·MaXcess Micro-Decompression Dissector

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317338402·

    COOLEY SUBRAMANIAN AORTIC CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921001430·COOLEY SUBRAMANIAN AORTIC CLAMP ANGLED JAW

    COOLEY SUBRAMANIAN AORTIC CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896010086·COOLEY SUBRAMANIAN AORTIC CLAMP ANGLED JAW

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707082354·BKT 43 F1000 SELF-LIGATING 22 T+7 A+5 BH

    PHYSICA PS FEMUR COMP.RIGHT #4

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JWH·January 4, 2024

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COROENT XLR STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 29, 2020

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 23, 2001

    PAINSMART

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 22, 2013

    CORDLESS DRIVER 2 HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·May 11, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code KDI·August 5, 2008

    SMR REVERSE HUMERAL BODY SHORT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·August 26, 2021

    SELEX/MAGNUM MOD HD 40MM -3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 23, 2013

    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 6, 2016

    SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2019