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

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    Vinyl Exam Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Distal Femur Plate,

    FDA UDI
    I.T.S. GmbH·09120034307041·Distal Femur Plate, 9-Hole, Right

    Cosmolock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm

    DATACAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CORTICAL SCREW, D=4.5MM

    FDA Adverse Event
    Malfunction ·I.T.S. GMBH·Product code HWC·January 8, 2019

    CORTICAL SCREW, D=4.5MM

    FDA Adverse Event
    Malfunction ·I.T.S. GMBH·Product code HWC·January 8, 2019

    CORTICAL SCREW, D=4.5MM

    FDA Adverse Event
    Malfunction ·I.T.S. GMBH·Product code HWC·January 8, 2019

    CORTICAL SCREW, D=4.5MM

    FDA Adverse Event
    Malfunction ·I.T.S. GMBH·Product code HWC·January 8, 2019

    DISTAL FEMUR PLATE, 9-HOLE

    FDA Adverse Event
    Malfunction ·I.T.S. GMBH·Product code HRS·January 8, 2019

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 30, 2014

    LUMAX 540 DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code LWS·August 9, 2011

    UNK

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 9, 2013

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017