BEUDAMED
    17 results · 38ms · 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 ×

    Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569318·CoRoent Ant TLIF Ti, 11x12x34mm 4°

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)

    Distal Ulna Plate

    FDA UDI
    I.T.S. GmbH·09120047297728·Distal Ulna Plate, 4-Hole, Left, Small

    NOBELACTIVE TIULTRA NP 3.5X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

    NOBELACTIVE TIULTRA NP 3.5X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·May 31, 2021

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    VANGUARD REPROCESSED PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TiUltra Implants and Xeal Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    *

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code HTX·October 8, 2008

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 15, 2011

    MAXGUARD PRE-SLIT INJECTION PORT

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·July 8, 2013

    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

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

    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

    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