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

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    TSC

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111377549·TRAY COVER FOR 10-1748&10-1749

    Personalized Mobile Floss Trial Pack Mint

    FDA UDI
    PRACTICON, INC.·00723896009345·Dental Floss

    Sklar

    FDA UDI
    SKLAR CORPORATION·30649111160244·TRAY COVER FOR 10-1748 PACK/12

    Sklar®

    FDA UDI
    SKLAR CORPORATION·30649111135549·COVER FOR 17-1748 - PACK OF 6

    ADMIRA FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    LUNAR REPORT GENERATOR II

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRA DRIVE 9.5MM DISK DRILL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JXE·September 27, 2012

    ULTRA DRIVE 5MM REVERSE CURETT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JXE·September 27, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 30, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 10, 2011

    PFC SIGMA DIS AUG 8MM, SZ4,RGHT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 7, 2008

    MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 18, 2023

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 18, 2023

    MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 18, 2023

    Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·September 12, 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

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 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 Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023