FDA 510(k) Applications Submitted by Paul Smolenski
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190562 |
03/05/2019 |
iTotal Identity Cruciate Retaining Knee Replacement System |
Conformis, Inc. |
| K022303 |
07/16/2002 |
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER |
PHILIPS ULTRASOUND, INC. |
| K002397 |
08/07/2000 |
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER |
AGILENT TECHNOLOGIES, INC. |
| K192198 |
08/13/2019 |
Conformis Hip System |
Conformis, Inc. |
| K202690 |
09/15/2020 |
Remunity Pump for Remodulin (treprostinil) Injection |
DEKA Research and Development |
| K213536 |
11/05/2021 |
DEKA ACE Pump System |
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. |
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