2,814 results · 30ms · Sources: EU EUDAMED, US FDA

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FUKUDA DENSHI

FDA UDI
FUKUDA DENSHI CO.,LTD.·04538612913587·

FUKUDA DENSHI

FDA UDI
FUKUDA DENSHI CO.,LTD.·04538612910357·

HPD HEATER BASES

FDA 510(k)
FDA Class 2 ·Anesthesiology

HPD HUMIDIFIER WICK

FDA 510(k)
FDA Class 2 ·Anesthesiology

HPD HUMIDIFYING CHAMBER

FDA 510(k)
FDA Class 2 ·Anesthesiology

HPD TUBING CONNECTORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

inSIGHT Ultima

FDA UDI
DIVERSATEK HEALTHCARE, INC.·B019ULT1HPD0·inSIGHT Ultima® HRM System

HPD STERILE HUMIDIFYING CHAMBER

FDA 510(k)
FDA Class 2 ·Anesthesiology

PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·December 4, 2025

NEEDLE 21GA 1-1/2IN

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·April 29, 2020

BD VACUTAINER LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 20, 2021

ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; Intended to deliver x-ray radiation for therapeutic treatment of cancer. ARTISTE with 160 MLC, Part No.8139789, ONCOR AG with 160 MLC, Part No.5863472 ONCOR Impression Plus with 160 MLC, Part No.5857912, ONCOR Expression with 160 MLC, Part No.7360204, ONCOR Expression with 160 MLC, Part No.7360717, PRIMUS HI with HPD, Part No. 4504200, MEVATRON M2 / PRIMUS Mid-Energy / HPD, Part No.1940035, MEVATRON 6323-2 / HPD, Part No.19244500, MEVATRON K2 / HPD, Part No.1940753, MEVATRON PRIMART / HPD, Part No.5500371, MEVATRON 77 / HPD, Part No.5659503, MEVATRON M 7400 / 7440 (MEX) / HPD, Part No.5672977, MEVATRON M 6700 (MX) / HPD, Part No.5693908, MEVATRON M 6730 / HPD, Part No.5694005, MEVATRON M 7140 / HPD, Part No.5694104, MEVATRON M 7400 / HPD, Part No.5694153, MEVATRON M 7445 / HPD (MEX), Part No.5694203, MEVATRON K 7467 / HPD, Part No.5694252, MEVATRON K 7767 / HPD, Part No.5694302, MEVATRON K 8067 / HPD, Part No.5694401, MEVATRON M 6300 (MX) / HPD, Part No.8317000, MEVATRON M 6730/6740 (MEX) / HPD, Part No.8319758, MEVATRON MD (MD, MDX) / HPD, Part No.8319808, MEVATRON KD / HPD, Part No.8319857, MEVATRON MDX / HPD, Part No.8496200, MEVATRON KD-2 / HPD, Part No.8515520, MEVATRON M3 6300 / HPD, Part No.9401316, MEVATRON M2 6700 / HPD, Part No.9401407, MEVATRON M2 6740 / HPD, Part No.9401506, MEVATRON KDS / HPD, Part No.941522, MEVATRON MD-2 / HPD, Part No.9401654, MEVATRON MDX 2 / HPD, Part No.9401746, MEVATRON KDS-2 / HPD, Part No.9411588, MEVATRON KD-2 / HPD, Part No.9822685, MEVATRON KDS-2 / HPD, Part No.9822693

FDA Recall
Terminated ·Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510 4040 Nelson Ave Concord CA 94520-1200·Product code IYE·August 13, 2010

EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER

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

BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·November 6, 2025

BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 12, 2020

EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)

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

GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·July 5, 2023

IV BOTTLE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES HPD·Product code KPE·September 23, 2003

MOLECULAR HUMIDITY CHAMBER AND FEED SET

FDA Adverse Event
Injury ·HPD MEDICAL, INC.·Product code BTT·January 10, 1994

ABBOTT PLUM PUMP

FDA Adverse Event
Injury ·ABBOTT LABS, HPD·Product code FRN·April 9, 1999