BEUDAMED
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    KMM Group, Ltd

    FDA registration
    KMM Group, Ltd·1 product·🇺🇸 United States

    Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction

    FDA Enforcement
    Class I ·Ongoing·Allergan PLC·September 18, 2019

    Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019

    Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code KMM·November 14, 2003

    K2M, INC.

    FDA registration
    K2M, INC.·46 products·🇺🇸 United States

    ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)

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

    Kam Yuen Plastic Products Ltd.

    FDA registration
    Kam Yuen Plastic Products Ltd.·4 products·🇨🇳 China

    BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM

    FDA 510(k)
    FDA Class 2 ·Dental

    CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Quantum

    FDA UDI
    Omm Imports Inc.·00850001456746·Over the counter red/IR device for the treatmen...

    Glorifico Plus

    FDA UDI
    Omm Imports Inc.·00850001456555·Over the counter red/IR device for the treatmen...

    Recreo

    FDA UDI
    Omm Imports Inc.·00850001456067·Over the counter laser/led device for hair growth.

    AECOR 250 Neck Pro

    FDA UDI
    Omm Imports Inc.·00850001456234·

    Relaxatio

    FDA UDI
    Omm Imports Inc.·00850001456357·Over the counter Red/IR LED Heating device for ...

    Juvenis

    FDA UDI
    Omm Imports Inc.·00850001456128·Over the counter red/ir device for the treatmen...

    Glorifico

    FDA UDI
    Omm Imports Inc.·00850001456531·Over the counter red/IR device for the treatmen...

    Perfectio X

    FDA UDI
    Omm Imports Inc.·00850001456036·Over the counter red/IR device for the treatmen...

    AECORMax Body

    FDA UDI
    Omm Imports Inc.·00850001456418·