BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNI Mod Hip

    FDA UDI
    Omni Life Science, Inc.·00841690102984·Modular Neck 13 degree Anteversion, Short 35

    Certi-Gauze Pads - 3"x 3" - 100/Box

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588312057·Certi-Gauze Pads - 3"x 3" - 100/Box

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180160989·PRISM CERVICAL CURETTE 10" ANGLED 90° 3, DARK GREY

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197536073·HAUSMANN Intestinal Clamp, angled shanks 205mm,...

    ARTHROCARE HEAD AND NECK COBLATION WAND

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

    PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 9, 2023

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 17, 2023

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 10, 2008

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 18, 2011

    PFC KEEL TIB TRAY CEM SZ2.5

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JWH·July 17, 2013

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·October 4, 2016

    CAPIOX

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 4, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020