FDA 510(k) Applications Submitted by Cathy S
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000328 |
02/02/2000 |
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP |
MEDEX, INC. |
| K982640 |
07/29/1998 |
MEDEX 3000 SERIES SYRINGE INFUSION PUMP |
MEDEX, INC. |
| K963904 |
09/30/1996 |
P.H.D. - PERSONAL HEART DEVICE MODEL 5258 |
HEART ALERT, INC. |
| K090413 |
02/18/2009 |
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC |
BAYER HEALTHCARE, LLC |
| K222910 |
09/26/2022 |
Bronchoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd |
| K002360 |
08/03/2000 |
CLOUD CUFF |
PARTS PORT, LTD. |
| K240374 |
02/07/2024 |
Ureterorenoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
| K250695 |
03/07/2025 |
Single-use Ureteral Access Sheath |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
| K241444 |
05/22/2024 |
Biliary Pancreaticobiliary Scope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
| K231497 |
05/24/2023 |
Choledochoscope System |
Shenzhen HugeMed Medical Technical Development Co., Ltd |
| K232435 |
08/14/2023 |
Rhinolaryngoscope system |
Shenzhen HugeMed Medical Technical Development Co., Ltd. |
| K030240 |
01/23/2003 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K030578 |
02/24/2003 |
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
| K022897 |
09/03/2002 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K023095 |
09/18/2002 |
HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
| K024294 |
12/24/2002 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
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