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

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    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AF541

    FDA UDI
    Respironics, Inc.·00606959024717·AF541, Bronchoscopy Elbow, Click Style,

    LASIK SPATULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896072589·LASIK SPATULA SINGLE ENDED SEMI-SHARP TIP TITANIUM

    SafeGuide®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734021125·Esophageal Dilator, 42 French

    MaxFuse VBR, 10 (D) x 12 (W) x 54 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055622·10 (D) x 12 (W) x 54 (H)

    V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...

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

    OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034781·Corpectomy, 12Dx14Wx42H 6°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064764·Corpectomy, 12Dx14Wx42H 0°

    PERCLOSE PROGLIDE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MGB·August 4, 2017

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 29, 2014

    PORTEX 9.0MM VOCALAID TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTL., LTD.·Product code JOH·May 6, 2011

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

    Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020

    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022