BEUDAMED
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    REFLECTION 3 ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Richard Wolf GmbH·04055207013830·FIBER LIGHT CABLE Ø 2.5MM TL 2.3M

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70612531·BioQuick-Brackets FACE Evolution II System .022...

    SURGITRON IEC II

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

    FLAVORED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SMARTMONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

    IMUFLEX DISPOSABLES

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code CAK·April 16, 2013

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWP·April 11, 2011

    SMARTMONITOR 2 PROFESSIONAL SERIES

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024