BEUDAMED
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    Intense Pulsed Light (IPL) System

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584114759·CZ9 MNR T R, 2.4G NFM SABE DEMO CORAL 9 GPL

    GLOBAL ADVANTAGE

    FDA UDI
    DEPUY (IRELAND)·10603295090106·GLOBAL ADVANTAGE + CASE 2 COMPLETE

    C3 ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    FLAT TITANIUM PECTUS BAR 10.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 12

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 30, 2014

    COLLEAGUE PRE P1.7

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

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code HCG·July 9, 2013

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 13IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 12, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 11IN

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    FLAT TITANIUM PECTUS BAR 12.5

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 9, 2025

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023