BEUDAMED
    10 results · 30ms · 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 ×

    MODEL OBC-63 BREAST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

    INSTANT-VIEW Pregnancy Combo Dip-Strip Test

    FDA UDI
    ALFA SCIENTIFIC DESIGNS, INC.·10796918000085·INSTANT-VIEW HCG Combo Dip-Strip Test

    MODIFICATION TO:ENDIUS BIPOLAR SHEATH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KELO-COTE TOPICAL GEL

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

    SOFTHEAT

    FDA Adverse Event
    Other ·KAZ, INC.·Product code IRT·March 15, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 15, 2011

    UNKNOWN RIGIDFIX FEMORAL ROD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·March 31, 2008

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014