BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    Oral/Enteral Syringe

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772412471·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK I

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010605153·MTO TREPHINE DRILL 8MM (STERILE)

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745045·Gorney Septal Scissors 7-3/4" (19.4cm), double ...

    ERBE APC 3

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·January 26, 2024

    MEDLINE HYPODERMIC NEEDLE 1 G X 1.5 INCH

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES, LP - NORTHFIELD·Product code FMF·March 30, 2022

    SHENGKUN CHEMICAL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCU-SPACE ABSORBABLE SEEDING SPACERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·December 31, 2024

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·October 23, 2008

    LEGEND FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·August 12, 2011

    PROMOTE ACCEL CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    Alinity m Integrated Reaction Units (IRU)

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·March 9, 2022

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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