BEUDAMED
    14 results · 21ms · 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 ×

    CIDEX OPA CONCENTRATE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K082959

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664812412·SpO2 interface cable/Philips-Masimo/2.2M/309+12...

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735463947·One-piece ECG Monitor Cable Philips

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950026609·LATEX TUBING 1/4"X1/16" BLACK 50' RL NS W/L

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032959·Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs C...

    Lingual Sheaths

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156984·WELD LINGUAL SHEATH UL 036 SLOTTED R7M W/DIST I...

    SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    URINARY CATHETER - NELATON UST. 16/040CM/78 0C

    FDA Adverse Event
    Malfunction ·CONVATEC·Product code KOD·April 1, 2013

    TARGET TIP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011

    BI-SWIVELOCK C 5.5MM X 15MM, CLOSED EYELET

    FDA Adverse Event
    Other ·ARTHREX, INC.·Product code MAI·April 22, 2008

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024