BEUDAMED
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    ORTHOFLEX ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814640·GENUMEDI SILVER SIZE I

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277114181·DAA Canal Finder Rasp with Orange Handle

    D5A Fully-Adjustable Articulator

    FDA UDI
    WHIP-MIX CORPORATION·D04011026011·A dental articulator is a device designed to si...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556637·Gutta Percha Points is used to root canal filin...

    Cal OSHA - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal

    CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFIRM DO DIODE LASER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 30, 2025

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 1, 2013

    HANAULUX 2000

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FTD·August 28, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011

    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code JTO·November 9, 2022

    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 1, 2021

    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025