BEUDAMED
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    BODY ANALYSIS SCALE, MODEL BG 17

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840916122249·Zeus-O Implant, 11 x 09 x 28mm

    MOBIS 0°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844001684·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911092818·.019 X .025 POSTED SS RIGHT FORM WIRES 28MM (10)

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P11092870·11mm PLIF Implant 9mm Wide 28mm Length, 7 deg L...

    MICRO DIARY SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROLITE VL PULSED LIGHT SYSTEM

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

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL-7 COLOR SCREEN HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 29, 2015

    RDS3 DOCKING STATION

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 17, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 8, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·March 18, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 8, 2014

    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024