BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NA

    FDA UDI
    Richard Wolf GmbH·04055207014387·BRONCHOSCOPE-TUBE ID 7.5MM model Hemer, OD 8.5...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114130·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

    HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DXY·October 9, 2013

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 24, 2014

    FMP HIP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code LPH·July 19, 2011

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017