FDA 510(k) Applications Submitted by Steve Li
| 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 |
| K241055 |
04/17/2024 |
Electro Lube NXT |
Steris |
| K242773 |
09/13/2024 |
Electro Lube NXT |
Steris |
| K193253 |
11/18/2019 |
Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 |
Shenzhen Changkun Technology Co., Ltd. |
| K193386 |
12/06/2019 |
Wrist Electronic Sphygmomanometer |
Shenzhen Changkun Technology Co., Ltd. |
| K193387 |
12/06/2019 |
Arm Electronic Sphygmomanometer |
ShenZhen Changkun Technology CO.,LTD. |
| 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. |
| K231405 |
05/15/2023 |
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode |
Jiangsu Rong Fu Kang Medical Instruments Co., Ltd. |
| K192208 |
08/14/2019 |
CORNICE Cervical Spacer System |
Legend Spine Technologies |
| K210285 |
02/02/2021 |
Adaptable Ortho Innovations Intramedullary Nail System |
Adaptable Ortho Innovations, LLC |
| K233838 |
12/04/2023 |
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); CovidienÖ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneo |
Medtronic, Inc |
| 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 |
| K150778 |
03/25/2015 |
Various Brands of Ultraviolet Lamps |
COSMEDICO LIGHT, INC. |
| K152095 |
07/28/2015 |
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) |
COSMEDICO LIGHT, INC. |
| K152273 |
08/12/2015 |
Cosmedico Ultraviolet Lamps of Various Models |
Cosmedico Light, Inc |
| K063275 |
10/30/2006 |
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) |
TERRAY CORP. |
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