BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    K-STERILE TENS ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556601563·SOD ACUFEX DRCTR ACL TBL AMR

    ZORTRAN DETECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Lumipulse G CA19-9-N

    FDA 510(k)
    FDA Class 2 ·Immunology

    CURRENT DR RF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·November 10, 2010

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 15, 2024

    Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·January 7, 2016

    Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·October 8, 2014

    Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·April 20, 2016

    PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Enforcement
    Class II ·Terminated·Customed, Inc·September 9, 2015

    PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013