BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    FUJINON ULTRASONIC PROCESSOR

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

    Vatech Clismile

    FDA UDI
    Rayence Co., Ltd.·08800018601075·This product is an orthodontic bracket and is u...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112430·Awl Tap, 5.5 mm, Fixed Sleeve

    CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MEDART DIODE LASER SYSTEM & ACCESSORIES

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

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·January 18, 2017

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 8, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·June 2, 2011

    TURBO-JECT POWER INJECTABLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·July 3, 2018

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2017

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 14, 2024

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·June 28, 2018

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR

    FDA Enforcement
    Class III ·Terminated·Allergan PLC·December 25, 2019

    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Round Mod 10888628001220, NATRELLE Style 10-270 Gel Round Mod 10888628001237, NATRELLE Style 10-300 Gel Round Mod 10888628001244, NATRELLE Style 10-330 Gel Round Mod 10888628001251, NATRELLE Style 10-360 Gel Round Mod 10888628001268, NATRELLE Style 10-390 Gel Round Mod 10888628001275, NATRELLE Style 10-420 Gel Round Mod 10888628001282, NATRELLE Style 10-450 Gel Round Mod 10888628001299, NATRELLE Style 10-510 Gel Round Mod 10888628001312, NATRELLE Style 10-800 Gel Round Mod 10888628001374, Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus 10888628001381, NATRELLE Style 15-176 Gel Round Mod Plus 10888628001398, NATRELLE Style 15-194 Gel Round Mod Plus 10888628001404, NATRELLE Style 15-213 Gel Round Mod Plus 10888628001411, NATRELLE Style 15-234 Gel Round Mod Plus 10888628001428, NATRELLE Style 15-265 Gel Round Mod Plus 10888628001435, NATRELLE Style 15-286 Gel Round Mod Plus 10888628001442, NATRELLE Style 15-304 Gel Round Mod Plus 10888628001459, NATRELLE Style 15-339 Gel Round Mod Plus 10888628001466, NATRELLE Style 15-371 Gel Round Mod Plus 10888628001473, NATRELLE Style 15-397 Gel Round Mod Plus 10888628001480, NATRELLE Style 15-421 Gel Round Mod Plus 10888628001497, NATRELLE Style 15-457 Gel Round Mod Plus 10888628001503, NATRELLE Style 15-492 Gel Round Mod Plus 10888628001510, NATRELLE Style 15-533 Gel Round Mod Plus 10888628001527, NATRELLE Style 15-575 Gel Round Mod Plus 10888628001534, NATRELLE Style 15-616 Gel Round Mod Plus 10888628001541, NATRELLE Style 15-659 Gel Round Mod Plus 10888628001558, NATRELLE Style 15-700 Gel Round Mod Plus 10888628001565, NATRELLE Style 15-752 Gel Round Mod Plus 10888628001572, Style 20/UDI: NATRELLE Style 20-230 Gel Round High 10888628001633, NATRELLE Style 20-280 Gel Round High 10888628001657, NATRELLE Style 20-300 Gel Round High 10888628001664, NATRELLE Style 20-325 Gel Round High 10888628001671, NATRELLE Style 20-350 Gel Round High 10888628001688, NATRELLE Style 20-375 Gel Round High 10888628001695, NATRELLE Style 20-400 Gel Round High 10888628001701, NATRELLE Style 20-425 Gel Round High 10888628001718, NATRELLE Style 20-450 Gel Round High 10888628001725, NATRELLE Style 20-475 Gel Round High 10888628001732, NATRELLE Style 20-500 Gel Round High 10888628001749, NATRELLE Style 20-550 Gel Round High 10888628001756, NATRELLE Style 20-600 Gel Round High 10888628001763, NATRELLE Style 20-650 Gel Round High 10888628001770, NATRELLE Style 20-700 Gel Round High 10888628001787, NATRELLE Style 20-750 Gel Round High 10888628001794, NATRELLE Style 20-800 Gel Round High 10888628001800, Style 40/UDI: NATRELLE Style 40-160 Gel Round Mod 10888628001855, NATRELLE Style 40-240 Gel Round Mod 10888628001893, NATRELLE Style 40-340 Gel Round Mod 10888628001947, Style 45/UDI: NATRELLE Style 45-120 Gel Round Extra High 10888628002005, NATRELLE Style 45-160 Gel Round Extra High 10888628002012, NATRELLE Style 45-240 Gel Round Extra High 10888628002036, NATRELLE Style 45-280 Gel Round Extra High 10888628002043, NATRELLE Style 45-320 Gel Round Extra High 10888628002050, NATRELLE Style 45-360 Gel Round Extra High 10888628002067, NATRELLE Style 45-400 Gel Round Extra High 10888628002074, NATRELLE Style 45-460 Gel Round Extra High 10888628002081, NATRELLE Style 45-500 Gel Round Extra High 10888628002098, NATRELLE Style 45-550 Gel Round Extra High 10888628002104, NATRELLE Style 45-600 Gel Round Extra High 10888628002111, NATRELLE Style 45-650 Gel Round Extra High 10888628002128, NATRELLE Style 45-700 Gel Round Extra High 10888628002135, NATRELLE Style 45-800 Gel Round Extra High 10888628002142,

    FDA Enforcement
    Class III ·Terminated·Allergan PLC·December 25, 2019