BEUDAMED
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    Fortis and Hana Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707001478·FIRST CLASS LEONE KIT 10 CASES .

    FMRI HARDWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    11 CM ANGLE ATTACHMENT QD11

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 15, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·April 1, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·August 25, 2022

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LQR·February 3, 2021

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·January 8, 2025

    N-COMPASS NITINOL STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code LQR·February 10, 2022

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026