FDA 510(k) Applications Submitted by Ma Maria

FDA 510(k) Number Submission Date Device Name Applicant
K241129 04/24/2024 Upper Arm Electronic Blood Pressure Monitor ShenZhen GoodlyMed Technology Co., Ltd.
K191036 04/18/2019 SyMRI SyntheticMR AB
K181093 04/25/2018 SyMRI SyntheticMR AB
K162943 10/21/2016 SyMRI SyntheticMR AB
K173558 11/17/2017 SyMRI SyntheticMR AB
K040894 04/06/2004 QBTEST QBTECH AB
K961499 04/18/1996 LAGUNA SOFTIP DIAGNOSTIC CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K981413 04/20/1998 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K961999 05/22/1996 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC.
K231826 06/21/2023 Omnipod 5 ACE Pump Insulet Corporation
K231824 06/21/2023 SmartBolus Calculator Insulet Corporation
K232569 08/24/2023 CAREMIBRAIN General Equipment for Medical Imaging, S.A.
K173815 12/15/2017 Allergan Botox Needle Electrode Natus Manufacturing Limited
K972810 07/28/1997 OPT80 THE TRANSPORTABLE (OPT80) O.P.T. USA, INC.
K970154 01/16/1997 KODAK EKTASIAN HG FILM (EHG-15) EASTMAN KODAK COMPANY
K970993 03/19/1997 DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE DEROYAL INDUSTRIES, INC.
K042863 10/18/2004 SCENIUM SIEMENS MOLECULAR IMAGING LTD
K133654 11/27/2013 SCENIUM SIEMENS MEDICAL SOLUTIONS USA, INC.
K033955 12/22/2003 RTIST MIRADA SOLUTIONS LTD.
K201217 05/06/2020 HemoCue Hb 301 System HemoCue AB
K181751 07/02/2018 HemoCue Hb 801 System HemoCue AB
K961436 04/15/1996 ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC.
K961620 04/26/1996 ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 ROCHE DIAGNOSTIC SYSTEMS, INC.
K961674 05/01/1996 ROCHE UNIMATE FRUCTOSAMINE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K961726 05/03/1996 ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 ROCHE DIAGNOSTIC SYSTEMS, INC.
K961824 05/10/1996 COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN ROCHE DIAGNOSTIC SYSTEMS, INC.
K962280 06/13/1996 ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR ROCHE DIAGNOSTIC SYSTEMS, INC.
K972250 06/16/1997 ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS ROCHE DIAGNOSTIC SYSTEMS, INC.
K962411 06/21/1996 ONTRAK TESTCUP AMPHETAMINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K982848 08/12/1998 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC.
K953847 08/16/1995 ROCHE REAGENT FOR GLUCOSE ROCHE DIAGNOSTIC SYSTEMS, INC.
K973284 09/02/1997 COBAS INTEGRA HDL-CHOLESTEROL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC.
K983174 09/10/1998 ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K983387 09/25/1998 ONTRAK TESTCUP AND TESTSTIK CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC.
K983556 10/13/1998 ABUSCREEN ONLINE BENZ 300 CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K983555 10/13/1998 ABUSCREEN ONLINE BENZ 200 CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K954992 10/31/1995 ROCHE COBAS INTEGRA REAGENT CASSETTES ROCHE DIAGNOSTIC SYSTEMS, INC.
K210958 03/31/2021 i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care Inc.
K182318 08/27/2018 Retina Workplace Carl Zeiss Meditec, Inc
K140325 02/10/2014 Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System JOINSOON MEDICAL TECHNOLOGY CO, LTD.
K101262 05/05/2010 FLEXI-LITE PRESSURE-TECH, INC.
K141200 05/09/2014 PADI-LOCK PADI-LOCK, LLC
K131420 05/16/2013 PETITE BASIC SYSTEM 701 ELT MEGO AFEK AC LTD
K081694 06/17/2008 DENJECTOR DXM CO., LTD.
K122774 09/10/2012 SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG SAKURA SEIKI CO., LTD.
K082811 09/24/2008 URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS URIT MEDICAL ELECTRONIC CO., LTD.
K100234 01/26/2010 HM-LAMP II HILLUSA, INC.
K113494 11/25/2011 NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA NOBLES MEDICAL TECHNOLOGIES II, INC.
K113763 12/21/2011 SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE NOBLES MEDICAL TECHNOLOGIES II, INC.
K040822 03/30/2004 LIQUICHEK TORCH PLUS IGM CONTROL BIO-RAD LABORATORIES, INC.
K061675 06/14/2006 VISION VXC CENTRAL STATION, MODEL 4300 INVIVO CORPORATION
K212227 07/16/2021 Philips MR Patient Care Portal Invivo Corporation
K120884 03/23/2012 PERICAM PSI PERIMED AB
K131253 05/02/2013 PERIFLUX 6000 PERIMED AB
K161973 07/18/2016 G-scan Brio, S-scan Esaote S.p.A.
K050063 01/11/2005 PROSTATE-63 CANCER DIAGNOSTIC TEST ASYMMETRX
K170022 01/03/2017 Klockner Vega TiBase for CEREC SOADCO S.L.
K080224 01/29/2008 KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK SOADCO, S.L.
K151194 05/04/2015 KLOCKNER DENTAL IMPLANT ABUTMENTS (II) SOADCO, S.L.
K082200 08/04/2008 KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 SOADCO, S.L.
K052654 09/26/2005 KLOCKNER DENTAL IMPLANT, MODEL S3M SOADCO, S.L.
K122988 09/26/2012 KLOCKNER DENTAL IMPLANT ABUTMENTS SOADCO, S.L.
K153098 10/26/2015 KLOCKNER VEGA DENTAL IMPLANT SYSTEM SOADCO, S.L.
K173642 11/24/2017 KLOCKNER SURGICAL BOX Soadco, S.L.
K213442 10/25/2021 Extroducer Infusion Catheter System Smartwise Sweden AB
K151622 06/16/2015 St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electroph St. Jude Medical
K093383 10/30/2009 NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG BIOMERIEUX, INC.
K220989 04/04/2022 Next Generation NetKonnect Nihon Kohden Digital Health Solutions, Inc.
K132284 07/23/2013 VECTRA NEO CLINICAL THERAPY SYSTEM DJO, LLC
K162048 07/25/2016 EZstim*III Peripheral Nerve Stimulator/Nerve Locator HALYARD HEALTH - IRVINE
K130183 01/25/2013 SFI BAR ABUTMENTS STERNGOLD DENTAL LLC
K150250 02/03/2015 SternSnap Angled Attachment Sterngold Dental, LLC
K020391 02/06/2002 STERN MICRO ERA ATTACHMENT SYSTEM STERNGOLD
K130408 02/19/2013 ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT STERNGOLD DENTAL LLC
K020949 03/25/2002 APOLLO, MODEL 1124525 STERNGOLD
K021045 04/01/2002 ERA IMPLANT STERNGOLD
K150968 04/13/2015 TRU Dental Implant System Sterngold Dental, LLC
K021367 04/30/2002 STERNGOLD 66, MODEL #1180230 STERNGOLD
K021741 05/28/2002 CRITERTION, MODEL #1067511 STERNGOLD
K171728 06/12/2017 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm Sterngold Dental, LLC
K111798 06/27/2011 STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... STERNGOLD DENTAL LLC.
K022252 07/12/2002 STERNGOLD 1, MODEL 1127781 STERNGOLD
K151928 07/14/2015 PUR Dental Implant System STERNGOLD DENTAL, LLC
K142407 08/28/2014 Straight Stud Attachment Sterngold Dental, LLC
K132814 09/09/2013 SFI-BAR IMPLANT ABUTMENTS STERNGOLD DENTAL LLC
K142667 09/19/2014 Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm Sterngold Dental, LLC
K143051 10/23/2014 ArgenIS Titanium Abutments THE ARGEN CORPORATION
K153173 11/03/2015 MOR Implant System STERNGOLD DENTAL, LLC
K133791 12/13/2013 ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] STERNGOLD DENTAL LLC
K110457 02/17/2011 3M TEGADERM MATRIX DRESSING 3M COMPANY
K080620 03/04/2008 MODIFICATION TO 3M TEGADERM CHG DRESSING 3M COMPANY-3M HEALTH CARE
K170754 03/13/2017 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing 3M Company, 3M Health Care
K063458 11/15/2006 3M TEGADERM CHG DRESSING 3M COMPANY
K153571 12/15/2015 Cavilon Advanced High Endurance Skin Protectant 3M HEALTH CARE
K960109 01/11/1996 QUANTITATIVE SENTINEL SYSTEM QUANTITATIVE MEDICINE, INC.
K992948 08/31/1999 MAC-LAB SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K993008 09/07/1999 QUANTITATIVE SENTINEL SYSTEM MARQUETTE MEDICAL SYSTEMS, INC.
K963608 09/10/1996 QUANTITATIVE SENTINEL SYSTEM QUANTITATIVE MEDICINE, INC.
K964770 11/27/1996 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K955559 12/06/1995 COROMETRICS FETAL MOVEMENT DETECTION KIT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K100401 02/16/2010 SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM HU-FRIEDY MFG. CO., INC
K120659 03/05/2012 HU-FRIEDY DENTAL CARTRIDGE SYRINGE HU-FRIEDY MFG. CO. LLC
K040277 02/05/2004 LIQUICHEK CARDIAC MARKER CONTROL LT BIO-RAD LABORATORIES, INC.
K050536 03/02/2005 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL BIO-RAD
K020878 03/18/2002 LYPHOCHEK HEMOSTASIS, MODELS 798, 799 BIO-RAD
K021498 05/09/2002 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL BIO-RAD
K071319 05/10/2007 I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 BIO-RAD, DIAGNOSTICS GRP.
K041561 06/10/2004 LIQUICHEK WHOLE BLOOD VOLATILES CONTROL BIO-RAD
K071675 06/19/2007 LIQUICHEK TUMOR MARKER CONTROL Bio-Rad Laboratories
K022041 06/24/2002 LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 BIO-RAD LABORATORIES, INC.
K032017 06/30/2003 LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 BIO-RAD
K012513 08/06/2001 LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 BIO-RAD
K012656 08/13/2001 LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 BIO-RAD
K012722 08/15/2001 LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 BIO-RAD
K012741 08/16/2001 LIQUICHEK TDM CONTROL BIO-RAD
K032611 08/25/2003 LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 BIO-RAD
K042335 08/30/2004 ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 BIO-RAD LABORATORIES, INC.
K042336 08/30/2004 METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK BIO-RAD LABORATORIES, INC.
K022991 09/09/2002 LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 BIO-RAD
K042446 09/09/2004 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC.
K052838 10/07/2005 LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 BIO-RAD
K033366 10/21/2003 LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 BIO-RAD
K033387 10/23/2003 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD
K033404 10/24/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) BIO-RAD
K073080 10/31/2007 QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 Bio-Rad Laboratories
K043208 11/19/2004 LIQUID ASSAYED MULTIQUAL CONTROL BIO-RAD
K042324 08/27/2004 LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 BIO-RAD
K082781 09/22/2008 OEC 9900 ELITE GE HEALTHCARE SURGERY
K073543 12/17/2007 OEC 9900 ELITE GE OEC MEDICAL SYSTEMS
DEN110012 04/13/2011 APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED
K122062 07/13/2012 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER GEN-PROBE, INC.
K991225 04/12/1999 MTI 1 ML SYRINGE MICRO THERAPEUTICS, INC.
K001390 05/02/2000 BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES BIOSENSE WEBSTER, INC.
K002333 08/01/2000 BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 BIOSENSE WEBSTER, INC.
K973579 09/19/1997 AM SERIES HEARING AID A & M HEARING, LTD.
K040653 03/12/2004 PARAMOUNT MINI GPS BILIARY STENT SYSTEM EV3 INC
K000864 03/17/2000 INTRASTENT DOUBLESTRUT XS STENT INTRATHERAPEUTICS, INC.
K080901 03/31/2008 LBI EMBOLECTOMY SYSTEM LUMEN BIOMEDICAL, INC.
K001257 04/19/2000 INTRACOIL STENT INTRATHERAPEUTICS, INC.
K021563 05/13/2002 INTRACOIL SELF-EXPANDING PERIPHERAL STENT SULZER INTRATHERAPEUTICS, INC.
K021729 05/24/2002 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K071529 06/05/2007 XTRACT CATHETER SYSTEM LUMEN BIOMEDICAL, INC.
K011806 06/11/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K012066 07/02/2001 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K082348 08/15/2008 FIBERNET EMBOLIC PROTECTION SYSTEM LUMEN BIOMEDICAL, INC.
K003040 09/29/2000 INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY INTRATHERAPEUTICS, INC.
K023243 09/30/2002 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K014136 12/17/2001 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY SULZER INTRATHERAPEUTICS, INC.
K052513 09/14/2005 BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 DELTA ENTERPRISE CORPORATION
K050836 04/01/2005 CRP DIAGNOSTIC ASSAY SENTINEL CH. SRL
K011893 06/18/2001 COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES CONTACT COLOR SRL
K052518 09/14/2005 PIEZOSURGERY PIEZOSURGERY SRL
K043408 12/10/2004 PIEZOSURGERY DEVICE PIEZOSURGERY SRL
K060768 03/22/2006 PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS ABBOTT DIABETES CARE INC.
K070984 04/06/2007 THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS ABBOTT DIABETES CARE INC.
K143164 11/03/2014 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set KIMBERLY-CLARK CORPORATION
K170044 01/05/2017 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System PRISMATIK DENTALCRAFT, INC.
K120149 01/18/2012 SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA SAKURA SEIKI CO., LTD.
K090362 02/13/2009 IMAG, IPOD, EZ-FIND AND ISLIDE VOGUESTRAP
K080636 03/06/2008 DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 HUBDIC CO., LTD
K090712 03/18/2009 EOCENE SYSTEM INFOPIA CO., LTD
K091168 04/22/2009 GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 INFOPIA CO., LTD
K121366 05/07/2012 HEMOCUE HBA1C 501 INFOPIA CO., LTD
K101348 05/13/2010 AGACHAMBER SPACER AGAPLASTIC IND. COM. LTDA.
K111382 05/17/2011 CELVER CELLULOSE CONCEPTS LLC
K081398 05/19/2008 ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES ADVANCED MEDICAL INNOVATIONS, INC.
K091975 07/01/2009 INTEGRATED LABORATORY AUTOMATION SOLUTION INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC.
K082020 07/16/2008 ENVISION BLOOD GLUCOSE TEST SYSTEM INFOPIA CO., LTD
K072108 08/01/2007 MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES TECNIMED S.R.L.
K132439 08/05/2013 SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER SAKURA SEIKI CO., LTD.
K082275 08/11/2008 CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 INFOPIA CO., LTD
K082586 09/08/2008 LIGHTWAVE PROFESSIONAL DELUXE LIGHTWAVE TECHNOLOGIES LLC
K082882 09/30/2008 A.V. FISTULA BLUNT NEEDLE SET JMS NORTH AMERICA CORP.
K243935 12/20/2024 Aptima CMV Quant Assay Hologic, Inc.
K163271 11/21/2016 i-Stat Alinity System with i-Stat Glucose test Abbott Point of Care, Inc.
K191813 07/05/2019 MobileDiagnost wDR 2.2 Sedecal SA
K040266 02/05/2004 CORE NEEDLE BIOPSY REMINGTON MEDICAL, INC.
K152930 10/05/2015 PeriFlux6000 PERIMED AB
K201583 06/11/2020 SmartCT R1.0 Philips Medical Systems, Nederland B.V.
K220329 02/04/2022 G-CAM Graphenano Dental S.L.
K962781 07/17/1996 COROMETRICS MODEL 510 AND 511 MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K163646 12/23/2016 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene SA
K200272 02/04/2020 Terragene Chemdye Terragene SA
K191021 04/17/2019 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye Terragene SA
K991739 05/21/1999 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K151814 07/06/2015 SERVO-U Ventilator System, SERVO-n Ventilator System MAQUET CRITICAL CARE AB
K120163 01/19/2012 ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM ACUTE INNOVATIONS LLC
K101170 04/26/2010 ACUTE INNOVATIONS STERNAL FIXATION SYSTEM ACUTE INNOVATIONS LLC
K141383 05/27/2014 ACUMED HAND FRACTURE SYSTEM ACUMED, LLC
K132769 09/04/2013 ACUMED HAND PLATING SYSTEM ACUMED LLC
K113318 11/10/2011 ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM ACUTE INNOVATIONS LLC
K232480 08/16/2023 ProtekDuo Veno-Venous Cannula Sets CardiacAssist, Inc.
K023662 10/31/2002 PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER HWADONG INTERNATIONAL COMPANY LTD.
K972672 07/16/1997 BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY BARZELL-WHITMORE MAROON BELLS, INC.
K002562 08/17/2000 PACIFIER THERMOMETER MODELS VT-901F, VT901C VALEO CORP.
K983623 10/15/1998 MODULAP ATC TECHNOLOGIES, INC.
K964660 11/20/1996 PARAMAX CHOLESTEROL REAGENT DADE INTL., INC.
K964715 11/25/1996 PARAMAX SALICYLATE REAGENT DADE INTL., INC.
K994319 12/22/1999 MODULAP ATC TECHNOLOGIES, INC.
K964565 11/14/1996 PARAMAX AMMONIA AND AMMONIA BLANK REAGENT DADE INTL., INC.
K964346 10/31/1996 PARAMAX TRIGLYCERID REAGENT DADE INTL., INC.
K960103 01/11/1996 DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS DADE INTL., INC.
K013133 09/19/2001 NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 NORDIX, INC.
K964041 10/08/1996 CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS ROBERT R. STEVENS
K955270 11/15/1995 TAPE & BANDAGE, ADHESIVE ROBERT R. STEVENS
K982445 07/15/1998 MODULAP ATC MEDICAL TECHNOLOGY, INC.
K082620 09/09/2008 ONCE-A-DAY VERTOS TEST PACK PROPPER MFG. CO., INC.
K201491 06/04/2020 Neodent Implant System - Zirconia Implant System JJGC Industria e Comercio de Materiais Dentarios S.A.
K202282 08/12/2020 Neodent Implant System - Zirconia Implant System JJGC Industria e Comercio de Materiais Dentarios SA
K142419 08/28/2014 Mini and Micro Fragments Reconstruction System-NEOFIX NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
K162874 10/13/2016 Cannulated Screws Neoortho Neoortho Produtos Ortopedicos S/A
K220251 01/31/2022 Neodent Implant System - GM Narrow Implant System JJGC Industria e Comercio de Materiais Dentarios S.A.
K210336 02/05/2021 Neodent Implant System - Zirconia Implant System JJGC Industria e Comercio de Materiais Dentarios SA
K190718 03/20/2019 Zygomatic Implants JJGC Industria e Comercio de Materiais Dentarios S.A.
K190958 04/12/2019 Neodent Implant System JJGC Industria e Comercio de Materiais Dentarios S.A.
K191191 05/03/2019 Neodent Implant System - Temporary Abutments JJGC Industria e Comercio de Materiais Dentarios S.A.
K201225 05/06/2020 Neodent Implant System - GM Helix Implants 7.0 JJGC Industria e Comercio de Materiais Dentarios S.A.
K231803 06/20/2023 Neodent Implant System - Zirconia Implant System JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A.
K232099 07/13/2023 Neodent Implant System - GM Zygomatic Implant System JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A.
K192229 08/16/2019 Neodent Implant System- GM Titanium Base for Bridge JJGC Industria e Comercio de Materiais Dentarios S.A.
K202515 09/01/2020 NUVO Implant System û NUVO Instrument Kit Cases JJGC Industria e Comercio de Materiais Dentarios S.A.
K203309 11/10/2020 NUVO CF Implant System JJGC Ind·stria e ComΘrcio de Materiais Dentßrios SA
K203382 11/17/2020 Neodent Implant System-Easy Pack JJGC Industria e Comercio de Materiais Dentarios S.A.
K203542 12/03/2020 Neodent Implant System - Mini Abutment 60░ JJGC Industria e Comercio de Materiais Dentarios S.A.
K193592 12/23/2019 Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants JJGC Industria e Comercio de Materiais Dentarios S.A.
K180204 01/24/2018 CranioMaxillofacial Fixation (CMF) System - CMF Visionare Visionare LLC
K211499 05/14/2021 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) 23andMe, Inc.
K221885 06/29/2022 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports 23andMe, Inc.
K223597 12/02/2022 23andMe« Personal Genome Service« (PGS«) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe, Inc.
K071050 04/13/2007 GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM COOLSYSTEMS, INC.
K072620 09/17/2007 GAME READY CLASSIC SYSTEM, MODEL 550550 COOLSYSTEMS, INC.
K200417 02/20/2020 RIST Radial Access Catheter RIST Neurovascular, Inc.
K191551 06/12/2019 RIST Cath Radial Access Long Sheath RIST Neurovascular, Inc.
K201682 06/22/2020 RIST Radial Access Catheter RIST Neurovascular, Inc.
K020085 01/10/2002 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X SINTEA BIOTECH, INC.
K031154 04/11/2003 SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X SINTEA BIOTECH, INC.
K022065 06/25/2002 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X SINTEA BIOTECH, INC.
K070816 03/26/2007 PERIPHERAL GUIDING SHEATH MICRUS DESIGN TECHNOLOGY, INC.
K233398 10/03/2023 Faros Surgical System Oertli Instrumente AG
K230931 04/03/2023 Atlan DrΣgerwerk AG Co. KGaA
K150412 02/18/2015 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group Ltd
K141100 04/29/2014 OPTILITE C1 INACTIVATOR KIT THE BINDING SITE GROUP LTD
K143118 10/30/2014 Human Microalbumin kit for use on SPAPLUS THE BINDING SITE GROUP LTD
K113349 11/14/2011 HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO THE BINDING SITE GROUP LTD
K200063 01/13/2020 AeroEclipse* ONE BAN Trudell Medical International
K181649 06/22/2018 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) Trudell Medical International
K242667 09/05/2024 AeroChamber2go Anti-Static Valved Holding Chamber Trudell Medical International
K173367 10/26/2017 MC 300* Nebulizer Trudell Medical International
K183108 11/08/2018 Combined Aerobika OPEP and VersaPAP device Trudell Medical International
K203400 11/19/2020 Corrugated tube with mouthpiece accessory Trudell Medical International
K173825 12/18/2017 MC 300R* Nebulizer Trudell Medical International
K173918 12/22/2017 VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International
K970496 02/10/1997 HEARTPORT MAZE SYSTEM: CRYOPROBE SET HEARTPORT, INC.
K990772 03/09/1999 DIRECTFLOW ARTERIAL CANNULA HEARTPORT, INC.
K971291 04/07/1997 HEARTPORT ENDOARTERIAL RETURN CANNULA HEARTPORT, INC.
K981995 06/08/1998 QUICKDRAW VENOUS CANNULA HEARTPORT, INC.
K972570 07/10/1997 HEARTPORT INTRODUCER SHEATH HEARTPORT, INC.
K964302 10/29/1996 HEARTPORT THORACIC TROCAR HEARTPORT, INC.
K974175 11/06/1997 HEARTPORT ENDOAORTIC CLAMP CATHETER HEARTPORT, INC.
K994243 12/16/1999 DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP HEARTPORT, INC.
K965051 12/18/1996 HEARTPORT NEEDLE TROCAR HEARTPORT, INC.
K974736 12/19/1997 HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER HEARTPORT, INC.
K981009 03/18/1998 HEARTPORT ENDOPULMONARY VENT CATHETER HEARTPORT, INC.
K212786 09/01/2021 LevaLap Laparoscopic Access Device Core Access Surgical Technologies, Inc.


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