BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    TRAUMACAD VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cook

    FDA UDI
    COOK INCORPORATED·00827002141896·Fascial Dilator

    CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OSSTELL RESONANCE FREQUENCY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Dental

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2021

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 23, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 13, 2011

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE·Product code MHX·July 1, 2008

    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.

    FDA Recall
    Terminated ·Excelsior Medical Corp·Product code NZW·April 28, 2016

    Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis.

    FDA Recall
    Terminated ·Excelsior Medical Corp·Product code NZW·May 7, 2012

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012