BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CARTO XP EP NAVIGATION SYSTEM, VERSION 10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450530320·

    COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 22, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

    TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 6, 2013

    TALENT AAA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·September 16, 2014

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·April 6, 2011

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012