BEUDAMED
    25 results · 21ms · 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 ×

    RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002112·artVeneer life upper posteriors, L, C3

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00210121·

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007824·Dennis Coarctation Clamp

    BetaForce

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730022011·Beta3 Upper 21x25 10 archwires per pack

    BetaForce™

    FDA UDI
    Ortho Organizers, Inc.·00190707124427·BETAFORCE Beta³ Upper 21x25 (10pk)

    ANCA Test System

    FDA UDI
    IMMUNO CONCEPTS INC·M749100211221·cANCA Positive Control - 2 x 1 ml.

    ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

    FDA 510(k)
    FDA Class 1 ·Dental

    GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOCUS DAILIES

    FDA Adverse Event
    Injury ·CIBA VISION CORP.·Product code LPL·July 21, 1998

    CRONIN SILASTIC BREAST IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·May 19, 1994

    HEYER-SCHULTEZ SALINE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR CORP.·Product code FWM·May 19, 1994

    HEYER-SCHULTE SALINE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR CORP.·Product code FWM·May 19, 1994

    UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·April 8, 2024

    UNKNOWN DEPUY PINNACLE ACETABULAR CUP

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 13, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·February 4, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 20, 2008

    SYRINGE S2 20ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 27, 2020

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020