BEUDAMED
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    InnovaBurn

    FDA 510(k)
    FDA Unclassified ·Unknown

    ScrewPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105640·3.7mmD x 16mmL, 4.7mmD Platform

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8962137160·Cottle nasal osteotome, cvd., 6mm, 18cm, 7"

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 12, 2025

    ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·May 21, 2025

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·June 25, 2025

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    OPEN SCREWDRIVER - MODULAR TI

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code HXX·October 28, 2008

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 3, 2013

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

    AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, 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 Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

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

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014