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

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    CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

    FDA 510(k)
    FDA Class 1 ·Dental

    RIGIDFIX

    FDA UDI
    Medos International Sàrl·10886705020065·RIGIDFIX CURVE Cross Pin System FEMORAL ROD, So...

    NA

    FDA UDI
    Synthes GmbH·10886982153081·3.5MM LOCKING SCREW SELF-TAPPING 22MM

    GLOBAL AP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295090816·GLOBAL AP X-RAY TEMPLATE

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PURESLEEP

    FDA 510(k)
    FDA Class 2 ·Dental

    *

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW,INC., ENDOSCOPY DIVISION·Product code HRX·August 8, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·October 30, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    MAGNETOM Cima.X (DE). Model Number: 11647158.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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

    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