BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902003523·CROSSLINK 8110614 CDH ANT PLT 14MM TI

    ASP

    FDA UDI
    SEDATELEC·03760262490403·The ASP Original, Semi-Permanent Needle, is an ...

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642112467·Modular Spacer, 26 mm (W) x 26 mm (L) x 15 mm (...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803116·Weitlaner Retractor, 3x4 Prong, Sharp, 16.5cm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106140·Trial, 26 x 14mm, 8 Degree, Tapered, Straight

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100140·Implant Tray

    HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDACTA BIPOLAR HEADS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code KWY·June 26, 2012

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·H10·Product code KWP·April 4, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024