BEUDAMED
    20 results · 22ms · 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 ×

    PlutoX Digital Intraoral X-Ray Imaging System

    FDA 510(k)
    FDA Class 2 ·Dental

    Bendini

    FDA UDI
    Nuvasive, Inc.·00887517605054·Bendini Adjustable Open Pointer

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780065708·The mini Kompressor Compression Screw is a two-...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707074·Preservation Rhinoplasty: Convex Transverse Saw

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038887·ROSA BUSHING FOR sEEG, LONG – STANDARD, FOR 2.4...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103120·Shaver, Closed, 12mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024076·Paddle Shaver, 12mm

    Tryptik Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLICKFINE AUTOPROTECT PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GALAXY G3 MINI 1MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 21, 2020

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·July 22, 2015

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    ACTIVA SC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·August 9, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 8, 2014

    BD NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 7, 2024

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 10, 2022

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 25, 2022

    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·May 8, 2015

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015