BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    IMPIX MANTA CERVICAL INTERBODY DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-70 80K FC Ø4.5 St

    FDA UDI
    Bien-Air Surgery SA·17630055504361·

    SleepWeaver Elan - Mask & Headgear - Large - Camo

    FDA UDI
    CIRCADIANCE, LLC·B036100484·SleepWeaver Elan Cloth Nasal PAP Mask & Headgea...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450178416·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190661·

    Tether™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981035754·Plate - 4 Level - 84mm

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981056407·Plate - 4 Level - 84 mm

    FUSTAR STEERABLE INTRODUCERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTI FRAME WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BD SAFETYGLIDE SYRINGE

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC·Product code FMF·September 4, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 8, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 13, 2011

    U1105 S1000 TINA HD WITH NIBP

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code FKP·August 4, 2008

    EXPEDIUM SINGLE-INNER SETSCREW

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES SPINE·Product code NKB·July 26, 2013

    ADVANCED PATELLA 35MM 3 PEG IMPLANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·January 9, 2024

    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

    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 Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 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 Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020