FDA 510(k) Applications Submitted by Steve Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980392 |
02/02/1998 |
PSI-TEC ASPIRATOR |
BYRON MEDICAL |
| K980738 |
02/25/1998 |
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION |
BYRON MEDICAL |
| K981172 |
04/01/1998 |
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES |
BYRON MEDICAL |
| K981215 |
04/02/1998 |
PSI-TEC LIPOSUCTION ASPIRATOR |
BYRON MEDICAL |
| K973133 |
08/21/1997 |
BIG BAG 3000 PRESSURE INFUSOR |
BYRON MEDICAL |
| K020078 |
01/09/2002 |
EXACTECH RESORBABLE BONE PASTE |
EXACTECH, INC. |
| K090417 |
02/18/2009 |
AXXENT FLEXISHIELD MINI |
XOFT, INC. |
| K090914 |
04/01/2009 |
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E |
XOFT, INC. |
| K111299 |
05/09/2011 |
AXXENT RADIATION SHIELD - RIGID |
XOFT, AN ICAD COMPANY |
| K181661 |
06/25/2018 |
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System |
Bio-Rad Laboratories, Inc. |
| K083734 |
12/16/2008 |
AXXENT SURFACE APPLICATOR, MODEL 710257 |
XOFT, INC. |
| K210285 |
02/02/2021 |
Adaptable Ortho Innovations Intramedullary Nail System |
Adaptable Ortho Innovations, LLC |
| K031799 |
06/10/2003 |
MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 |
MIELE, INC. |
| K251048 |
04/03/2025 |
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 |
STERIS Corporation |
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