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

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    POLYTEL(R) APT MODEL: PWA-08-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Trial Tibial Augment

    FDA UDI
    ADLER ORTHO SPA·08056269044172·TRIAL PANTHEON TIBIAL AUGMENT RM/LL SIZE 4 H5

    BLOXR

    FDA UDI
    BLOXR Solutions, LLC·10811042031740·XPF® Frontal Apron with CLOSED elastic back, X-...

    Aira

    FDA UDI
    AIRA, LLC·00810194400568·3.50 x 9 - Paper/Blue Film Self-Sealing Sterili...

    Tru-Arch Ni-Ti

    FDA UDI
    ORMCO CORPORATION·00889989027181·NITI CR TRU-ARCH 19x25 UPR MED-BP/100

    COOLEY BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921005240·COOLEY BULLDOG CLAMP RING HANDLE FULL CURVED

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471155783·V Nat D 018X025 Lo

    House Brand Dentistry

    FDA UDI
    Frontier Dental Supply Inc·00810132800306·3.50" x 9" - Paper/Blue Film Self-Sealing Steri...

    HS Diam. Burr, Ø6.0x70, 50k

    FDA UDI
    Bien-Air Surgery SA·07630055506658·

    Locator® Component

    FDA UDI
    BICON, LLC·00813110023766·Locator Impression Kit

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425329·NiTi SE Archwire, NAT .018x.025 Lower Dimple 10EA

    HARDYDISK, CEFOTAXIME 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TECO DIAGNOSTICS UTI DETECTION STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 16, 2021

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 5, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 24, 2011

    LEAD 6972

    FDA Adverse Event
    Injury ·MEDTRONICS·Product code DTB·August 5, 2008

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023