FDA 510(k) Applications Submitted by Paul Smolenski

FDA 510(k) Number Submission Date Device Name Applicant
K240256 01/31/2024 Remunity System Deka Research and Development
K250357 02/07/2025 RemunityPROÖ Pump for Remodulin« (treprostinil) Injection DEKA Research & Development Corp.
K190562 03/05/2019 iTotal Identity Cruciate Retaining Knee Replacement System Conformis, Inc.
K240920 04/04/2024 HemoCare Bicarbonate Concentrate Set (BCS) DEKA Research and Development
K241178 04/29/2024 DEKA ACE Pump System DEKA Research and Development
K241736 06/17/2024 Remunity 2.0 Pump for Remodulin (treprostinil) Injection DEKA Research and Development Corp.
K022303 07/16/2002 PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER PHILIPS ULTRASOUND, INC.
K232316 08/03/2023 DEKA Infusion System, DEKA Administration Set DEKA Research and Development
K002397 08/07/2000 M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER AGILENT TECHNOLOGIES, INC.
K192198 08/13/2019 Conformis Hip System Conformis, Inc.
K242693 09/09/2024 DEKA Infusion System, DEKA Administration Set DEKA Research and Development Corporation
K202690 09/15/2020 Remunity Pump for Remodulin (treprostinil) Injection DEKA Research and Development
K243354 10/29/2024 Remunity System DEKA Research & Development Corp.
K213536 11/05/2021 DEKA ACE Pump System DEKA Research and Development
K233557 11/06/2023 HemoCare Hemodialysis System Deka Research and Development
K233952 12/15/2023 DEKA ACE Pump System Deka Research and Development
K234055 12/22/2023 DEKA Loop Deka Research and Development
K972465 07/01/1997 ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD.
K954022 08/28/1995 ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD.
K963616 09/10/1996 ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD.
K983879 11/02/1998 ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD.
K964549 11/13/1996 ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER ALOKA CO., LTD.
K974544 12/04/1997 ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER ALOKA CO., LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact