FDA 510(k) Applications Submitted by S H TAN

FDA 510(k) Number Submission Date Device Name Applicant
K092492 08/13/2009 POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O WEAR SAFE (MALAYSIA) SDN. BHD.
K090327 02/09/2009 POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE WEAR SAFE (MALAYSIA) SDN. BHD.
K093500 11/12/2009 POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE WEAR SAFE (MALAYSIA) SDN. BHD.
K183425 12/11/2018 CARDIOVIT AT-102 G2 Schiller AG
K102153 07/30/2010 MOBIUS ULTRASOUND IMAGING SYSTEM MOBISANTE, INC.
K952326 05/18/1995 PULMOMIST GLOBAL MEDICAL ENT., INC.
K172361 08/04/2017 EEA Circular Stapler with Tri-Staple Technology Covidien
K192330 08/27/2019 EEA Circular Stapler with Tri-Staple Technology Covidien
K192720 09/27/2019 GIA Stapler with Tri-Staple Technology Covidien
K150145 01/22/2015 MD322C8 31.5 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD.
K161057 04/14/2016 Diagnostic Imaging Color LCD Monitor NEC DISPLAY SOLUTIONS LTD.
K142951 10/10/2014 MD210C3 21.3 Diagnostic Imaging LCD Monitor NEC DISPLAY SOLUTIONS LTD.
K103337 11/15/2010 MULTIPLE NAME IDEAL QUALITY SDN., BHD.
K213371 10/12/2021 Disposable Medical Nitrile Examination Gloves (Model:XYS-001) Anhui Xinyisheng Medical Technology Co.,Ltd
K220683 03/08/2022 INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Penumbra, Inc.
K221822 06/23/2022 BENCHMARK BMX81 Access System Penumbra, Inc
K991132 04/02/1999 ACTIVA HOVEROUND CORP.
K140660 03/14/2014 MOBIUS3D MOBIUS MEDICAL SYSTEMS, LP
K141230 05/13/2014 DOSELAB PRO MOBIUS MEDICAL SYSTEMS, LP
K153014 10/15/2015 Mobius3D MOBIUS MEDICAL SYSTEMS, LP
K201219 05/06/2020 Biocore9 Femoral Head Resurfacing Component BioCore9 LLC
K212761 08/31/2021 Biocore9 Acetabular Cup System Biocore9, LLC.
K193122 11/12/2019 Biocore9 Humeral Resurfacing System Biocore9, LLC.
K010064 01/08/2001 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 BECKMAN COULTER, INC.
K010066 01/08/2001 5C-ES CELL CONTROL, MODELS 7547191, 7547192 BECKMAN COULTER, INC.
K050057 01/11/2005 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K030408 02/07/2003 CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A BECKMAN COULTER, INC.
K030606 02/25/2003 COULTER LH 750 BODY FLUIDS APPLICATION BECKMAN COULTER, INC.
K010765 03/14/2001 COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 BECKMAN COULTER, INC.
K030828 03/14/2003 TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) BECKMAN COULTER, INC.
K011342 05/02/2001 COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC.
K032000 06/10/2003 COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K022161 07/03/2002 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC.
K032342 07/29/2003 COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K042724 10/01/2004 MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K993356 10/06/1999 COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES COULTER CORP.
K052905 10/14/2005 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER BECKMAN COULTER, INC.
K043215 11/19/2004 FLOWCARE PLG CD4 REAGENT BECKMAN COULTER, INC.
K090083 01/12/2009 CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 UNICARE BIOMEDICAL, INC.
K080532 02/26/2008 BENACEL, MODELS C-001, C-002 AND C-005 UNICARE BIOMEDICAL, INC.
K020720 03/05/2002 OSSIFORM UNICARE BIOMEDICAL, INC.
K090612 03/06/2009 BENACEL UNICARE BIOMEDICAL
K021511 05/09/2002 CYTOFLEX MESH UNICARE BIOMEDICAL, INC.
K151344 05/19/2015 Cytoflex Tefguard Ti-Enforced Membrane Unicare Biomedical, Inc.
K012144 07/10/2001 CYTOFLEX UNICARE BIOMEDICAL, INC.
K982699 08/03/1998 UNIGRAFE UNICARE BIOMEDICAL
K092567 08/20/2009 MODIFICATION TO UNIGRAFT UNICARE BIOMEDICAL, INC.
K003457 11/07/2000 UNIGRAFT UNICARE BIOMEDICAL
K993784 11/08/1999 UNIGRAFT UNICARE BIOMEDICAL
K960981 03/11/1996 KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY KODAK HEALTH IMAGING SYSTEMS, INC.
K982710 08/04/1998 AECD ARRHYTHMIA DETECTION SOFTWARE CARDIAC SCIENCE, INC.
K993533 10/19/1999 POWERHEART AECD CARDIAC SCIENCE, INC.
K172536 08/22/2017 Atlas Percussion Adjusting Instrument Spinalight, Inc
K143512 12/11/2014 ActiSpec Activity Monitor SLEEP MODUS, INC.
K040463 02/23/2004 AESKULISA CARDIOLIPIN AGM AESKU, INC
K040953 04/12/2004 AESKULISA ANA HEP-2 AESKU, INC
K051492 06/06/2005 AESKULISA ASCA A AESKU.INC
K041628 06/16/2004 AESKULISA DS DNA G AESKU.DIAGNOSTICS
K041753 06/29/2004 AESKULISA ENA 6 S AESKU.DIAGNOSTICS
K032469 08/11/2003 AESKULISA ANA 8PRO AESKU, INC
K052439 09/06/2005 AESKULISA GLIA A AND AESKULISA GLIA G AESKU.DIAGNOSTICS
K042644 09/27/2004 AESKULISA TTG A AND AESKULISA TTG G AESKU, INC
K171673 06/06/2017 Focus Cap GCE Medical Corporation
K051683 06/23/2005 POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING SHEN WEI (USA), INC.
K043546 12/23/2004 DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE DADE BEHRING, INC.
K022391 07/23/2002 MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION ORGAN RECOVERY SYSTEMS, INC.
K011427 05/08/2001 MBI PD-103 SL; MBI PD-103 SH MILLS BIOPHARMACEUTICALS, INC.
K980071 01/08/1998 SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX LATEX PRODUCTS SDN. BHD.
K010198 01/22/2001 STERILE POWDERED LATEX SURGEON GLOVES SUPERMAX GLOVE MANUFACTURING SDN BHD
K980494 02/09/1998 SUPERGLOVES SUPERMAX SDN BHD
K000644 02/25/2000 SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES SUPERMAX GLOVE MANUFACTURING SDN BHD
K980966 03/16/1998 SUPERGLOVES POWDERED NITRILE SUPERMAX SDN BHD
K991415 04/23/1999 SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD
K032501 08/13/2003 MAXTER STERILE POWDER FREE SURGICAL GLOVES MAXTER GLOVE MANUFACTURING SDN BHD
K993258 09/29/1999 SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES SUPERMAX SDN BHD
K013443 10/17/2001 POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 MAXTER GLOVE MANUFACTURING SDN BHD
K013498 10/22/2001 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) MAXTER GLOVE MANUFACTURING SDN BHD
K013554 10/25/2001 POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) MAXTER GLOVE MANUFACTURING SDN BHD
K013589 10/30/2001 CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA SUPERMAX GLOVE MANUFACTURING SDN BHD
K993864 11/15/1999 COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES SUPERMAX SDN BHD
K993865 11/15/1999 GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES SUPERMAX SDN BHD
K013953 11/30/2001 AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM SUPERMAX GLOVE MANUFACTURING SDN BHD
K024083 12/11/2002 GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR SUPERMAX GLOVE MANUFACTURING SDN BHD
K014230 12/26/2001 STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) SUPERMAX GLOVE MANUFACTURING SDN BHD
K991543 05/03/1999 INTRAOP CATHETER I-FLOW CORP.
K972203 06/11/1997 BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT ALLIED HEALTHCARE PRODUCTS, INC.
K994374 12/27/1999 SOAKER CATHETER I-FLOW CORP.
K955865 12/28/1995 BEAR CUB INFANT PRESSURE VENTILATOR ALLIED HEALTHCARE PRODUCTS, INC.
K100448 02/17/2010 ASCENSION MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDICS, INC.
K021362 04/30/2002 LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) ORGAN RECOVERY SYSTEMS, INC.
K013575 10/29/2001 KPS-I, THE KIDNEY PERFUSION SOLUTION ORGAN RECOVERY SYSTEMS, INC.
K984446 12/14/1998 `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH UROCOR, INC.
K103396 11/19/2010 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION i-SENS, Inc.
K991153 04/06/1999 MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ MEDTEXX INDUSTRIES (THAI) CO. LTD.
K182582 09/19/2018 Oryum and Ovem Epidermal Deri Prick Test Applicator Allergy & Applicator Depot, LLC
K100238 01/27/2010 HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DEPUY ORTHOPAEDICS, INC.
K090374 02/17/2009 STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S DEPUY ORTHOPAEDICS, INC.
K090492 02/25/2009 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS DEPUY ORTHOPAEDICS, INC.
K140622 03/11/2014 DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE BIOMET, INC.
K090877 03/31/2009 PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DEPUY ORTHOPAEDICS, INC.
K150867 04/01/2015 Affixus Tibial Nailing System BIOMET, INC.
K111077 04/18/2011 ORTHOSORB RESORBABLE PINS DEPUY ORTHOPAEDICS, INC.
K081155 04/23/2008 SMARTSET MV BONE CEMENT DEPUY ORTHOPAEDICS, INC.
K081163 04/24/2008 SMARTSET GMV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC.
K091294 05/04/2009 LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DEPUY ORTHOPAEDICS, INC.
K101240 05/04/2010 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DEPUY ORTHOPAEDICS, INC.
K091453 05/18/2009 LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DEPUY ORTHOPAEDICS, INC.
K101421 05/20/2010 MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DEPUY ORTHOPAEDICS, INC.
K111444 05/24/2011 UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION DEPUY ORTHOPAEDICS, INC.
K081546 06/02/2008 SMALL BONE LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K131670 06/07/2013 LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) BIOMET, INC.
K111663 06/14/2011 TRAUMA INTERNAL FIXATION SYSTEMS DEPUY ORTHOPAEDICS, INC.
K131867 06/24/2013 2.5MM INLINE FUSION PLATE BIOMET, INC.
K072083 07/30/2007 SMALL FRAGMENT LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K112218 08/02/2011 ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DEPUY ORTHOPAEDICS, INC.
K082300 08/12/2008 ANATOMIC LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K112345 08/15/2011 DISTAL VOLAR RADIUS PLATING SYSTEMS MEDOS INTERNATIONAL SARL
K072423 08/29/2007 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. DEPUY ORTHOPAEDICS, INC.
K132704 08/29/2013 DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW BIOMET
K072832 10/03/2007 ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K162897 10/17/2016 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser BECKMAN COULTER
K093474 11/06/2009 DEPUY FRACTURE AND FUSION PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K083364 11/13/2008 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 DEPUY ORTHOPAEDICS, INC.
K103408 11/19/2010 POSTERIOR LATERAL PLATES DEPUY ORTHOPAEDICS, INC.
K083789 12/19/2008 ACE FISCHER EXTERNAL FIXATION SYSTEM DEPUY ORTHOPAEDICS, INC.
K133939 12/23/2013 MODIFIED DISTAL RADIUS PLATING SYSTEM BIOMET
K083843 12/24/2008 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DEPUY ORTHOPAEDICS, INC.
K052509 09/13/2005 M-BOLUS EMBOLIC MICROSPHERES SCION CARDIO-VASCULAR, INC.
K103001 10/06/2010 ROCKWOOD CLAVICLE PINS DEPUY ORTHOPAEDICS, INC.
K222593 08/26/2022 TruPlan Computed Tomography (CT) Imaging Software Circle Cardiovascular Imaging, Inc.
K213998 12/21/2021 cvi42 Auto Imaging Software Application Circle Cardiovascular Imaging Inc


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