FDA 510(k) Applications Submitted by Alice Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220271 |
01/31/2022 |
Hand Diagnostic Radiography Imaging System |
NanoRay Biotech Co., Ltd |
| K243055 |
09/27/2024 |
PrΘime DermaFacial Collagen+ |
EMA Aesthetics, LTD |
| K243072 |
09/27/2024 |
PrΘime DermaFacial (MicroT) |
EMA Aesthetics, LTD |
| K042750 |
10/04/2004 |
QC-BEADS |
BIOSCREEN INC. |
| K140053 |
01/09/2014 |
KANGLI PEDICLE SCREW SPINAL SYSTEM |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K201698 |
06/22/2020 |
Medical Surgical Mask |
Hangzhou Mycode Bio-Medicine Co., Ltd. |
| K141825 |
07/07/2014 |
IDEAL Locking Plate System |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
| K133840 |
12/18/2013 |
Kangli Locking Plate System |
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD |
| K131601 |
06/03/2013 |
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE |
QUBYX LIMITED |
| K230407 |
02/15/2023 |
FloNavi Open Field Fluorescence Imaging System |
Guangdong OptoMedic Technologies, Inc. |
| K240454 |
02/15/2024 |
RESPONDER« Polysaccharide Hemostat |
Starch Medical, Inc. |
| K220525 |
02/23/2022 |
RESPONDER Polysaccharide Hemostat |
Starch Medical, Inc. |
| K193010 |
10/29/2019 |
Liebel-Flarsheim IBP Transfer Set |
Liebel-Flarsheim Company LLC |
| K063060 |
10/05/2006 |
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP |
BLUESHINE SRL |
| K240004 |
01/02/2024 |
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerab |
CIRCA Scientific, Inc. |
| K243954 |
12/23/2024 |
PeriCrossÖ Epicardial Access Kit |
CIRCA Scientific, Inc. |
| K202372 |
08/19/2020 |
Upper Arm Electronic Blood Pressure Monitor |
Conmo Electronic Company Limited |
| K180380 |
02/12/2018 |
vital signs monitor |
Edan Instruments, Inc. |
| K180862 |
04/02/2018 |
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System |
Edan Instruments, Inc |
| K170995 |
04/03/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K171178 |
04/21/2017 |
Central Monitoring System |
Edan Instruments, Inc. |
| K171824 |
06/19/2017 |
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System |
Edan Instruments Inc |
| K171942 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K171943 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K162055 |
07/25/2016 |
Acclarix LX8 Diagnostic Ultrasound System |
EDAN INSTRUMENTS INC |
| K172380 |
08/07/2017 |
U2 Diagnostic Ultrasound System |
Edan Instruments Inc |
| K202336 |
08/17/2020 |
Patient Monitor |
Edan Instruments, Inc. |
| K192514 |
09/12/2019 |
Patient Monitor |
Edan Instruments, Inc. |
| K172780 |
09/14/2017 |
SD1 Ultrasonic Pocket Doppler |
Edan Instruments Inc |
| K173003 |
09/27/2017 |
U50 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
| K173042 |
09/28/2017 |
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 |
Edan Instruments, Inc |
| K202892 |
09/28/2020 |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
| K192285 |
08/22/2019 |
CPR Face Shield |
Firstar Healthcare Company Limited (Guangzhou) |
| K010001 |
01/02/2001 |
LIVESURE THC SCREEN TEST |
PAN PROBE BIOTECH, INC. |
| K020968 |
03/26/2002 |
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD |
PAN PROBE BIOTECH, INC. |
| K010967 |
04/02/2001 |
LIVESURE COCAINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
| K011011 |
04/04/2001 |
LIVESURE MORPHINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
| K011610 |
05/25/2001 |
LIVESURE METHAMPHETAMINE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
| K011609 |
05/25/2001 |
LIVESURE AMPHETAMINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
| K012107 |
07/05/2001 |
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
| K012133 |
07/09/2001 |
LIVESURE BARBITURATES SCREEN TEST |
PAN PROBE BIOTECH, INC. |
| K012131 |
07/09/2001 |
LIVESURE BENZODIAZEPINES SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
| K013796 |
11/15/2001 |
LIVESURE METHADONE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
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