BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Magneto Nasal Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Trivex System

    FDA UDI
    Lemaitre Vascular, Inc.·00840663106530·Trivex System control unit with build in pump

    DG Gel 8 AB (x4)

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205947·The DG Gel 8 AB (x4) card is for the determinat...

    DG Gel 8 AB (x4)

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205022·The DG Gel 8 AB (x4) card is for the determinat...

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039860·GUIDE FOR VISUALASE

    Ballard* Closed Suction System for Adults

    FDA UDI
    Avanos Medical, Inc.·00609038983158·BALLARD* Closed Suction Catheter, Double Swivel...

    CELOX RAPID GAUZE

    FDA 510(k)
    FDA Unclassified ·Unknown

    DUO-DENT DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    INAVEIN TRIVEX SYSTEM - CONTROL UNIT

    FDA Adverse Event
    Other ·INAVEIN, LLC·Product code DWQ·September 10, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    INAVEIN TRIVEX SYSTEM - RESECTOR HANDPIECE

    FDA Adverse Event
    Other ·INAVEIN, LLC·Product code DWQ·September 17, 2008

    INAVEIN TRIVEX SYSTEM - RESECTOR HANDPIECE

    FDA Adverse Event
    Other ·INAVEIN, LLC·Product code DWQ·September 17, 2008

    Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CARE DSE TRACH; i. HALYARD* 14FR DSE 12IN/30.5CM; j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); r. HALYARD* 16FR TRACH CARE DSE ENDO; s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012