BEUDAMED
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    SPECTRASTIM 2000 MUSCLE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053020308·Barricade Coil System (BCS) is intended for the...

    SAFIRA

    FDA UDI
    MEDOVATE LIMITED·05060727270020·SAFIRA Driver unit that injects/aspirates works...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746094651·DB BRACKET MASTER SERIES MAND RIGHT CUSPID 022 ...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746101311·DB BRACKET MASTER SERIES MAND RIGHT CUSPID 022 ...

    Ortho Specialties

    FDA UDI
    Young Innovations, Inc.·00843471143865·Hooks, Short, 4Mm

    CONLIN MOLAR BAND

    FDA UDI
    Ortho Arch Company Inc·D90990002917·MOLAR BAND CONLIN RX UPPER LEFT 43

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508102960·Rod Pusher

    Inspire

    FDA UDI
    Inspire Medical Systems, Inc.·00810098650038·The Model 2740S SleepSync Programmer Applicatio...

    XBraid S

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00810020082777·Suture

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707050306·.018/.045 UR6 CV OCBT -14T 0A 14O

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

    MEPILEX BORDER AG DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    RELOAD-CURVED STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2014

    JAGWIRE¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·January 7, 2013

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 22, 2010

    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 25, 2018

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00884838059559(21)900018 (01)00884838059559(21)900019 (01)00884838059559(21)900020 (01)00884838059559(21)900021 (01)00884838059559(21)900022 (01)00884838059559(21)900023 (01)00884838059559(21)900024 (01)00884838059559(21)900025 (01)00884838059559(21)900026 (01)00884838059559(21)900027 (01)00884838059559(21)900028 (01)00884838059559(21)900029 (01)00884838059559(21)900030 (01)00884838059559(21)900031 (01)00884838059559(21)900032 (01)00884838059559(21)900033 (01)00884838059559(21)900034 (01)00884838059559(21)900035 Product Usage: The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 21, 2018