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

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    Fingertip Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777464·LUMBAMED PLUS FLEX PAD WM SILVER IV

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721988·Rubin Dorsal Osteotome 7" (17.5cm), 14mm wide

    Radius Plate PROlock, Small

    FDA UDI
    I.T.S. GmbH·09120034303180·Radius Plate PROlock, Small, 4-Hole, Right

    DELTAMAXX 18 MICROCOIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTODELFIA NEONATAL IRT KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACHIEVE ADVANCE MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DRF·May 6, 2025

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 22, 2008

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 8, 2011

    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

    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