BEUDAMED
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    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·INTRA COIL SELF-EXPANDING PERIPHERAL STENT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·INTRACOIL SELF-EXPANDING PERIPHERAL STENT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·INTRACOIL PERIPHERAL STENT

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964000315·Custom Procedure Kit

    The Stork OTC

    FDA UDI
    STORK IB2C, INC., THE·00810396020335·The Stork, Merck Femibion

    Tempo

    FDA UDI
    i-SENS, Inc.·00810011730045·Tempo lancet (100T/pack)

    Piccolo Kidney Check

    FDA UDI
    ABAXIS, INC.·EABA40000331·The Piccolo® Kidney Check , used with the Picco...

    QB1 NMES System

    FDA UDI
    Motive Health, Inc.·00854816006080·QB1 NMES System; MEDIUM, SHORT, RIGHT

    AP223-01- MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, FILTER AND NEE

    FDA UDI
    EITAN MEDICAL LTD·17290109154579·

    AP 223-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE,

    FDA UDI
    EITAN MEDICAL LTD·17290109154869·MICROBORE ADMINISTRATION SET WITH VENTED/NON-VE...

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·July 31, 2014

    Ultracheck

    FDA UDI
    Statcorp Medical·10841522100796·BP CUFF,MIDMARK,UC,2T,ADLT LONG, TWIN FITTING,EA

    XP4:1B MYOTHERM XP

    FDA Adverse Event
    Injury ·PERFUSION SYSTEMS·Product code DTN·August 28, 2025

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·TRIDENT SYSTEM

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES

    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·March 9, 2016

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LNQ·July 30, 2014

    ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM

    FDA Adverse Event
    Malfunction ·ATRIUM MEDICAL CORPORATION·Product code PRL·March 17, 2026

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS

    Joint, Temporomandibular, Implant

    FDA Pre-Market Approval
    FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM