BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    HORIZON/WESTHIN 55-G

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295241171·P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM ST...

    DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Siconus SI Joint Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code NJL·August 24, 2018

    REF H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Malfunction ·ARKRAY, INC.·Product code CGA·February 14, 2013

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·January 17, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 28, 2014

    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRS·November 29, 2017

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·August 27, 2013

    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HSB·March 16, 2026

    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code LXH·June 29, 2020

    RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024

    smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code KRO·February 1, 2018