BEUDAMED
    63 results · 20ms · 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 ×

    ACCENT

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

    LOCATOR, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481131615·LOCATOR R-Tx Attachment System for Abutment EV ...

    LOCATOR R-Tx, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481137037·LOCATOR R-Tx Abutment EV (S) 4mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110702·LOCATOR R-Tx Abutment for 3.6mm EV Internal Con...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114991·LOCATOR F-Tx Abutment for 3.6mm EV Internal Con...

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690033·Advanced Dental Implant Ø3.75mm L16mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129117·LOCATOR R-Tx Abutment, 3.6mm Astra EV Connectio...

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

    CLEARVIEW HCG URINE CASSETTE

    FDA Adverse Event
    Malfunction ·BIOSITE INC.·Product code JHI·March 5, 2009

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013

    CE INTERMATE SV 100, 48 PACK,50125

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 26, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 2, 2008

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra Silicone Gel Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra Silicone Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants