BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV

    cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Trinity Acetabular Hip System

    FDA UDI
    CORIN LTD·05055343897461·Insert Trial (Size 2)

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054323·ACCENT B/T 15DBL LFM -27TX18X18 LT

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706930·Neivert-Anderson Osteotome 8" (20cm), curved le...

    PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET

    FDA Adverse Event
    Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIF·June 16, 2022

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197493703·360° Laminectomy Punch 40° an...

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 13, 2016

    EZONO 3000

    FDA 510(k)
    FDA Class 2 ·Radiology

    Surgical laser fibers

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

    PUMP MMT-512NAP PRDGM INSULIN PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·October 22, 2008

    LOANER INSTRUMENTS (FOR HIP) ASI TAPERLOC

    FDA Adverse Event
    Malfunction ·BIOMET·Product code KWA·August 5, 2011

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013

    ARROW CVC SET: 3-LUMEN 7 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·April 9, 2018

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014