FDA 510(k) Applications Submitted by Lin Ma
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191122 |
04/29/2019 |
3M RelyX Pediatric Resin Modified Glass Ionomer Cement |
3M ESPE Dental Products |
| K152336 |
08/19/2015 |
HEX tanning booth |
J & B PRODUCTS LTD DBA HEX TANNING |
| K982672 |
07/31/1998 |
COLLEAGUE PUMP SYRINGE ADAPTER SET |
BAXTER HEALTHCARE CORP. |
| K983294 |
09/21/1998 |
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 |
BAXTER HEALTHCARE CORP. |
| K003245 |
10/17/2000 |
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML |
BAXTER HEALTHCARE CORP. |
| K052883 |
10/13/2005 |
CARDIOSERVER |
DATRIX |
| K053083 |
11/02/2005 |
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH |
DATRIX |
| K090804 |
03/25/2009 |
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
| K162840 |
10/11/2016 |
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 |
Roche Diagnostics |
| K143534 |
12/12/2014 |
Elecsys CA-125 II assay |
ROCHE PROFESSIONAL DIAGNOSTICS |
| K150712 |
03/19/2015 |
LTM-Perforated Surgical Mesh |
LifeCell Corporation |
| K981294 |
04/09/1998 |
ODYSSEY INSTRUMENTATION SYSTEM |
AUTOMATA INSTRUMENTATION, INC. |
| K992431 |
07/21/1999 |
NEO-2 METER |
AUTOMATA INSTRUMENTATION, INC. |
| K974127 |
11/03/1997 |
HYDRA METER |
AUTOMATA INSTRUMENTATION, INC. |
| K955298 |
11/20/1995 |
PHOENIX DIALYSATE METER |
AUTOMATA MEDICAL INSTRUMENTATION, INC. |
| K173844 |
12/19/2017 |
Titan Ag 200 |
Specialty Fibres and Materials Ltd |
| K140208 |
01/28/2014 |
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII |
EDWARDS LIFESCIENCES, LLC. |
| K100569 |
03/01/2010 |
MERIT EMBOLECTOMY CATHETER MODEL ASAP100 |
MERIT MEDICAL SYSTEMS, INC. |
| K162995 |
10/27/2016 |
Ibis« Pedicle Screw System |
Ortho Development Corporation |
| K030245 |
01/24/2003 |
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K971356 |
04/11/1997 |
POWDER FREE SYNTHETIC EXAMINATION GLOVES |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K021412 |
05/03/2002 |
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K991686 |
05/17/1999 |
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K031913 |
06/20/2003 |
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K031944 |
06/24/2003 |
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K041745 |
06/28/2004 |
VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K954153 |
09/05/1995 |
ARISTA VINYL EXAMINATION GLOVES |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K002746 |
09/05/2000 |
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K002745 |
09/05/2000 |
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K022987 |
09/09/2002 |
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K023072 |
09/16/2002 |
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K013320 |
10/05/2001 |
BLUE LATEX EXAMINATION GLOVES, POWDER FREE |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K023754 |
11/06/2002 |
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
| K023753 |
11/08/2002 |
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E |
ARISTA LATINDO INDUSTRIAL LTD. P.T |
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