BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TEAR LIGHT TAPE

    FDA UDI
    Mueller Sports Medicine, Inc.·00074676136851·TEAR LIGHT TAPE GOLD 2" X 7.5YD 24 ROLLS

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023558·Biogel Sensor Surgical 8.5 - 50 Pair/Box

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450535745·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450376331·

    ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEETH IN AN HOUR - ARK IMPLANT CONCEPT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·April 13, 2022

    TPRLC 133 T1 PPS HO 16X152MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·September 3, 2024

    TPRLC 133 MP TYPE1 PPS HO 12.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·September 3, 2024

    TPRLC XR T1 PPS 16X152MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·September 3, 2024

    RETROFLEX 3 DILATOR KIT

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DRE·May 24, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

    XEO 1064NM ND:YAG LASER

    FDA Adverse Event
    Other ·CUTERA BRISBANE·Product code GEX·June 2, 2011

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    FDA Recall
    Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012