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

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    Axon Therapy

    FDA 510(k)
    FDA Class 2 ·Neurology

    Temena

    FDA UDI
    Temena GmbH·03700339716135·Stimulation needle 20º bevel 21G x 100 mm

    10-LD EKG CABLE, BANANA, A nihon kohden

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828146098·10-LD EKG CABLE, BANANA, A nihon kohden

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0100210·Caddie Lid, Implant

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm

    DASH HIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    Widex

    FDA UDI
    Widex A/S·05706069691283·Widex BEYOND B-F2 (Warm beige ) 110, Telecoil, ...

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 12, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    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