BEUDAMED
    13 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.

    MODEL 52 BUNN DRY AIR SUPPLY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left

    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

    FDA 510(k)
    FDA Class 2 ·Immunology

    VisualEyes

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTRA-AORTIC BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 8, 1998

    CLINITRON AT HOME

    FDA Adverse Event
    Other ·HILL-ROM INC.·Product code INX·April 30, 2014

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·October 22, 2012

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·August 12, 2010

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·December 12, 2014

    Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 1, 2020

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023