FDA 510(k) Applications Submitted by Mark Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K172457 |
08/14/2017 |
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM |
Deltex Medical Limited |
| K072053 |
07/26/2007 |
SMARTBLOCK PAIN PUMP |
MEDICAL FLOW SYSTEMS LTD |
| K984129 |
11/18/1998 |
COAGULATION CONTROL LEVEL 1 (NORMAL) |
PACIFIC HEMOSTASIS |
| K984131 |
11/18/1998 |
COAGULATION CONTROL LEVEL 3 (ABNORMAL) |
PACIFIC HEMOSTASIS |
| K984130 |
11/18/1998 |
COAGULATION CONTROL LEVEL 2 (ABNORMAL) |
PACIFIC HEMOSTASIS |
| K221361 |
05/11/2022 |
circulÖ pro Ring |
BodiMetrics, LLC |
| K222158 |
07/20/2022 |
Capiflo 5001 |
K&L Distributing, Inc. |
| K250027 |
01/06/2025 |
Powered Mobility Scooter |
Intradin (Shanghai) Machinery Co., Ltd |
| K232692 |
09/05/2023 |
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) |
Intradin (Shanghai) Machinery Co., Ltd |
| K243970 |
12/23/2024 |
Portable Wheelchair |
Intradin (Shanghai) Machinery Co., Ltd |
| K960836 |
02/29/1996 |
DMS-9000 |
O.R. SOLUTIONS, INC. |
| K020710 |
03/05/2002 |
BIOTEST HEMOGLOBIN MEASURING SYSTEM |
BIOTEST MEDIZINTECHNIK GMBH |
| K061060 |
04/17/2006 |
TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 |
TISSUE TECHNOLOGIES HOLDINGS, LLC |
| K972781 |
07/25/1997 |
OT-1 |
PRISM THERAPEUTICS, LLC. |
| K043038 |
11/04/2004 |
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
| K060342 |
02/10/2006 |
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K |
ROSSMAX INTERNATIONAL LTD. |
| K981231 |
04/03/1998 |
CO2 |
ABBOTT MFG., INC. |
| K990035 |
01/06/1999 |
RF |
ABBOTT LABORATORIES |
| K981118 |
03/27/1998 |
PHOS |
ABBOTT LABORATORIES |
| K991175 |
03/29/1999 |
MODIFICATION TO ALCYON DIRECT BILIRUBIN |
ABBOTT LABORATORIES |
| K981185 |
04/02/1998 |
GLU |
ABBOTT LABORATORIES |
| K981189 |
04/02/1998 |
URIC ACID |
ABBOTT LABORATORIES |
| K981192 |
04/02/1998 |
MG |
ABBOTT LABORATORIES |
| K981216 |
04/03/1998 |
AMY |
ABBOTT LABORATORIES |
| K981218 |
04/03/1998 |
CREATINE KINASE (CK) |
ABBOTT LABORATORIES |
| K981221 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) |
ABBOTT LABORATORIES |
| K981222 |
04/03/1998 |
DIRECT BILIRUBIN (DBIL) |
ABBOTT LABORATORIES |
| K981224 |
04/03/1998 |
DIRECT HDL |
ABBOTT LABORATORIES |
| K981225 |
04/03/1998 |
ASPARTATE AMINOTRANSFERASE (AST) |
ABBOTT LABORATORIES |
| K981232 |
04/03/1998 |
CA |
ABBOTT MFG., INC. |
| K981240 |
04/06/1998 |
CREATININE (CREA) |
ABBOTT LABORATORIES |
| K981241 |
04/06/1998 |
IRON |
ABBOTT LABORATORIES |
| K981245 |
04/06/1998 |
ALKALINE PHOSPHATASE (ALKP) |
ABBOTT LABORATORIES |
| K981279 |
04/08/1998 |
TIBC |
ABBOTT LABORATORIES |
| K981295 |
04/09/1998 |
UPRO |
ABBOTT LABORATORIES |
| K981303 |
04/10/1998 |
DIRECT LDL |
ABBOTT LABORATORIES |
| K981336 |
04/13/1998 |
TBIL |
ABBOTT LABORATORIES |
| K981457 |
04/23/1998 |
ALBP |
ABBOTT MFG., INC. |
| K981467 |
04/23/1998 |
AMM |
ABBOTT LABORATORIES |
| K981468 |
04/23/1998 |
ALBG |
ABBOTT LABORATORIES |
| K981476 |
04/24/1998 |
CHOL |
ABBOTT LABORATORIES |
| K981578 |
05/04/1998 |
CA |
ABBOTT LABORATORIES |
| K981580 |
05/04/1998 |
HDL |
ABBOTT LABORATORIES |
| K981581 |
05/04/1998 |
IRON |
ABBOTT LABORATORIES |
| K981652 |
05/11/1998 |
CHOL |
ABBOTT LABORATORIES |
| K981654 |
05/11/1998 |
TIBC |
ABBOTT LABORATORIES |
| K981653 |
05/11/1998 |
AMY |
ABBOTT LABORATORIES |
| K981682 |
05/13/1998 |
UPRO |
ABBOTT LABORATORIES |
| K981706 |
05/14/1998 |
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
ABBOTT LABORATORIES |
| K981759 |
05/19/1998 |
PHOS |
ABBOTT LABORATORIES |
| K981758 |
05/19/1998 |
ALBG |
ABBOTT LABORATORIES |
| K981766 |
05/19/1998 |
URIC ACID |
ABBOTT LABORATORIES |
| K981791 |
05/21/1998 |
MG |
ABBOTT LABORATORIES |
| K981799 |
05/21/1998 |
CREA |
ABBOTT LABORATORIES |
| K981814 |
05/22/1998 |
ALBP |
ABBOTT LABORATORIES |
| K981840 |
05/26/1998 |
CO2 |
ABBOTT LABORATORIES |
| K981843 |
05/26/1998 |
AST |
ABBOTT LABORATORIES |
| K981918 |
06/01/1998 |
UREA |
ABBOTT LABORATORIES |
| K981920 |
06/01/1998 |
AMM |
ABBOTT LABORATORIES |
| K981943 |
06/03/1998 |
DBIL |
ABBOTT LABORATORIES |
| K181748 |
07/02/2018 |
Magnesium |
Abbott Laboratories |
| K993083 |
09/15/1999 |
ALCYON 300I (WITH ISE MODULE) ANALYZER |
ABBOTT LABORATORIES |
| K093318 |
10/23/2009 |
ACCELERATOR APS |
ABBOTT LABORATORIES |
| K963547 |
09/05/1996 |
THE WRAP IMMOBILIZATION SYSTEM |
SAFE RESTRAINTS, INC. |
| K030366 |
02/04/2003 |
BICARD MIXING SYSTEM |
DIALYSIS SYSTEMS, INC. |
| K212499 |
08/09/2021 |
BD Insulin Syringe (0.3mL) |
Becton, Dickinson and Company |
| K213156 |
09/20/2021 |
BD Nano 2nd Gen Pen Needle |
Becton, Dickinson and Company |
| K234009 |
12/19/2023 |
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical |
| K220132 |
01/18/2022 |
FIREFLY« Cervical Navigation Guide |
Mighty Oak Medical Inc. |
| K181399 |
05/29/2018 |
FIREFLY« Pedicle Screw Navigation Guide |
Mighty Oak Medical Inc. |
| K181883 |
07/13/2018 |
FIREFLY« Midline Navigation Guide |
Mighty Oak Medical Inc. |
| K162419 |
08/30/2016 |
FIREFLY« Pedicle Screw Navigation Guide |
MIGHTY OAK MEDICAL INC. |
| K080555 |
02/28/2008 |
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) |
IVU IMAGING CORPORATION |
|
|
