BEUDAMED
    37 results · 22ms · Sources: EU EUDAMED, US FDA

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    NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776186241·SUPERCUT LAHEY SCS - CVD

    IMMCO DIAGNOSTICS

    FDA UDI
    IMMCO DIAGNOSTICS, INC.·00845714000829·Hep-2 Cells -Anti-Nuclear Antibody IFA Kit

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH

    Viceroy

    FDA UDI
    DIOMEDICAL CO.,LTD.·08800113904682·VICEROY Rod - 5.5 (D)5.5x(L)120mm

    SEALED CALL CORD, 1/4" PLUG, 12FT, SF.

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828138086·SEALED CALL CORD, 1/4" PLUG, 12FT, SF.

    VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·April 29, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 26, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 8, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 28, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 23, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 9, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 16, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 11, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 24, 2022

    SERIES A PATELLA STD 34 3 PEG

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 2, 2014

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 28, 2022

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012