FDA 510(k) Applications Submitted by THOMAS M LI
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020022 |
01/03/2002 |
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K992638 |
08/06/1999 |
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 |
CRITIKON COMPANY,LLC |
| K014255 |
12/26/2001 |
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K042965 |
10/27/2004 |
TOMAS PIN |
DENTAURUM, INC. |
| K170072 |
01/09/2017 |
Fitmore« Hip Stem |
Zimmer GmbH |
| K200112 |
01/17/2020 |
Zimmer Hip Joint Replacement |
Zimmer GmbH |
| K212129 |
07/08/2021 |
Persona« Personalized Knee System |
Zimmer Switzerland Manufacturing GmbH |
| K203722 |
12/21/2020 |
RayPilot System |
Micropos Medical AB |
| K220398 |
02/11/2022 |
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire |
Scientia Vascular, LLC |
| K223913 |
12/29/2022 |
Socrates Aspiration System |
Scientia Vascular Inc |
| K230590 |
03/03/2023 |
ARDO Bellis |
ARDO Medical AG |
| K212773 |
08/31/2021 |
ARDO Alyssa |
ARDO Medical AG |
| K982461 |
07/15/1998 |
GLASIONOMER CEMENT CX PLUS |
SHOFU DENTAL CORP. |
| K973247 |
08/29/1997 |
VINTAGE HALO |
SHOFU DENTAL CORP. |
| K091325 |
05/05/2009 |
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS |
COOPER SURGICAL |
| K990352 |
02/05/1999 |
COULTER AC T DIFF 2 ANALYZER |
COULTER CORP. |
| K000500 |
02/14/2000 |
DINAMAP ADVANCED NIBP MODULE |
CRITIKON COMPANY, L.L.C. |
| K991070 |
03/31/1999 |
COULTER Z2 ANALYZER |
COULTER CORP. |
| K971469 |
04/22/1997 |
COULTER ACT TRON CELL CONTROL |
COULTER CORP. |
| K002248 |
07/25/2000 |
DINAMAP PRO 1000 MONITOR, MODEL 1000 |
CRITIKON COMPANY,LLC |
| K962988 |
08/01/1996 |
COULTER GEN-S SYSTEM |
COULTER CORP. |
| K012915 |
08/30/2001 |
DINAMAP PRO 1000 MONITOR, MODEL 1000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K973634 |
09/24/1997 |
COULTER AC.T DIFF ANALYZER |
COULTER CORP. |
| K964988 |
12/13/1996 |
COULTER AC.T SERIES ANALYZER |
COULTER CORP. |
| K954894 |
09/19/1995 |
HYTEC AUTOIMMUNE KITS (SCL-70) |
HYCOR BIOMEDICAL, INC. |
| K954897 |
09/19/1995 |
HYTEC AUTOIMMUNE KITS (RNP) |
HYCOR BIOMEDICAL, INC. |
| K954893 |
10/25/1995 |
HYTEC AUTOMIMMUNE KIT (DS-DNA) |
HYCOR BIOMEDICAL, INC. |
| K954895 |
10/25/1995 |
HYTEC AUTOIMMUNE KIT (JO-1) |
HYCOR BIOMEDICAL, INC. |
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