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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Koios DS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Richard-Allan® Needle 1/2 Circle Taper

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113216741·Intent to be used with suture material for tiss...

    Bernafon

    FDA UDI
    Bernafon AG·05711584114193·CZ7 B 105, 2.4G NFM SABE/MSIL CORAL 7 GPL

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383515146·"An absorbent paper points is an endodontic pap...

    CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 24, 2008

    TRILOGY ACETABULAR LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·August 11, 2011

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025