BEUDAMED
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    NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517824721·CoRoent XL Sizer, 13x18x45mm 10°

    Couture Essence

    FDA UDI
    Carolon Company·00078301972036·

    Couture Essence

    FDA UDI
    Carolon Company·00078301910236·

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756350136·MINOR ORTHO PACK

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158215771·SCISSOR STANDARD BLUNT/BLUNT STRAIGHT 5"

    H.A.M., 13-Channel w/ blank insert holes

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024718·

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 23, 2020

    H.A.M.,13-Chan w blank insert holes,Slot

    FDA UDI
    MICK RADIO NUCLEAR INSTRUMENT, INC·00817330024725·

    GE DATEX-OHMEDA AISYS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO CAVERMAP SURGICAL AID

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

    ECHELON FLEX 60

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY·Product code GDW·January 8, 2013

    QUICKIE 2 LITE

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC·Product code IOR·November 17, 2010

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·July 2, 2014

    Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·July 12, 2023

    Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292

    FDA Recall
    Open, Classified ·DeRoyal Industries Inc·Product code LRO·May 30, 2023