BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    Unifine SafeControl

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707258·Dorsal Nasal Rasp, 6-1/2" (16.5cm), straight, 2...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551068372·ROSA sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-6...

    GLADIATOR PLASMA CLASSIC HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)

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

    CT9000 ADV 115V/220V W/PED. +OB

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code DXT·August 8, 2011

    PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 13, 2014

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·July 8, 2013

    Ureteral dilator, REF RBD014

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024

    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

    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