BEUDAMED
    20 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.

    REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832015146·Flexible Reamer

    Armstrong Activent®

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490030304·VENT TUBE 1030170 5PK MOD ARMSTR GROMMET

    Baby Tischler Biopsy Punch Titanium

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030170·Baby Tischler Biopsy Punch Titanium 10" (254mm)...

    AOS TROCHANTERIC NAIL 10mm x 17cm x 125°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014624·

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174927·Z-Rod, Dia. 5.5mm, Titanium, 170mm

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114452·4.0mm X 70mm FULL THREAD CANNULATED SCREW

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197027236·Mayo Operating Scissors straig...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197413473·CERA-CUT® Mayo Scissors straig...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197038195·Super-Cut Mayo Scissor straig...

    SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000

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

    RYTHMIC AND RYTHMIC UV

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 28, 2013

    MULTIRATE INFUSOR LV 2,3,5,12PACK FOR JAPAN ONLY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 27, 2011

    PULMONETIC

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.·Product code CBK·April 14, 2008

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016