BEUDAMED
    20 results · 24ms · 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.

    FLOWPICC STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X0816250·8mm H x 16mm W x 25mm L x 0 degrees XLIF

    n/a

    FDA UDI
    Ortho Development Corporation·00822409075553·12/14 Press-Fit Broach 16x25

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L081625120·8mm H x 16mm W x 25mm L XLIF Trial 12 degree Lo...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X081625120·8mm H x 16mm W x 25mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X08162580·8mm H x 16mm W x 25mm L x 8 degrees XLIF

    Centaur Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215126605·

    PRONOVA NONABSORBABLE SUTURE, USP

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

    VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2027971-2026-081625

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·May 21, 2026

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 4, 2015

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 29, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 13, 2011

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Other ·INTUITIVE SURGICAL, INC.·Product code NAY·July 16, 2008

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LJT·November 17, 2017

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code LIT·May 23, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018