BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038955·ANCHOR BOLT CAP, BLANK, FOR 2.1MM DRILL, FITS A...

    Radius Plate PROlock II

    FDA UDI
    I.T.S. GmbH·09120047296462·Radius Plate PROlock II, 3-Hole, Right

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707081·Preservation Rhinoplasty: Concave Radix Saw

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103130·Shaver, Closed, 13mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024083·Paddle Shaver, 13mm

    TINA-QUANT HBA1C GEN.2

    FDA 510(k)
    FDA Class 2 ·Hematology

    DIMENSION CTNI FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·February 21, 2014

    RESTORE PRIME ADVANCED

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

    HEARTSTART MRX -EMS DEFIBRILLATOR

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

    LIFEVEST WCD 4000 SYSTEM

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

    CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

    FDA Adverse Event
    Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

    OT VERIO2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 3, 2017

    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

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

    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

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

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CJ4303 (Reorder No. 21-0313-01)110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 SureSite Prepierced injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    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