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