BEUDAMED
    21 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 ×

    mediCAD 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003906·MCK ONLAY INSERT TRIAL (SIZE 2 X 11mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003920·MCK ONLAY INSERT TRIAL (SIZE 2 X 13mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003951·MCK ONLAY INSERT TRIAL (SIZE 2 X 16mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003913·MCK ONLAY INSERT TRIAL (SIZE 2 X 12mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003890·MCK ONLAY INSERT TRIAL (SIZE 2 X 10mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003944·MCK ONLAY INSERT TRIAL (SIZE 2 X 15mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003876·MCK ONLAY INSERT TRIAL (SIZE 2 X 8mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003883·MCK ONLAY INSERT TRIAL (SIZE 2 X 9mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003937·MCK ONLAY INSERT TRIAL (SIZE 2 X 14mm)

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 4, 2021

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197072151·Finsen tracheal retractor 70mm, ...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409091638·I/M Tibial Cut Guide with Augment Slots Right

    FUSION RESIN CEMENT AND CORE KIT

    FDA 510(k)
    FDA Class 2 ·Dental

    STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 12, 2011

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 14, 2013

    EMERALD DIAGNOSTIC GUIDEWIRES

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code DQX·September 16, 2008

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·May 8, 2019

    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 20, 2016