FDA 510(k) Applications Submitted by JOSE PAUL M

FDA 510(k) Number Submission Date Device Name Applicant
K230661 03/10/2023 Zeta Cranial Navigation System Zeta Surgical
K130782 03/21/2013 ACCUMESH DEPLOYMENT SYSTEM Covidien LLC
K142335 08/21/2014 RapidVac Smoke Evacuator System COVIDIEN
K133938 12/23/2013 ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN
K031101 04/07/2003 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 HEMAGEN DIAGNOSTICS, INC.
K140996 04/17/2014 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
K161631 06/13/2016 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING
K162052 07/25/2016 Sentinella 102, Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
K143156 11/03/2014 Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
K170515 02/21/2017 Sterile Nitrile Surgical Gloves, Powder-free Primus Gloves PVT Limited
K170612 03/01/2017 STERILE VINYL EXAMINATION GLOVES, Powder Free Primus Gloves PVT Limited
K171367 05/09/2017 SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) Sanrea Healthcare Products Pvt Ltd
K023515 10/21/2002 PRE-POWDERED LATEX SURGEON'S GLOVES SANREA HEALTHCARE PRIVATE LIMITED
K010864 03/22/2001 ANALYST PANELS + ANALYTICAL TEST ROTOR HEMAGEN DIAGNOSTICS, INC.
K011126 04/13/2001 RAICHEM CREATININE URINE STANDARD HEMAGEN DIAGNOSTICS, INC.
K021194 04/15/2002 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM HEMAGEN DIAGNOSTICS, INC.
K022049 06/24/2002 MODIFICATION TO RAICHEM CALCIUM REAGENT HEMAGEN DIAGNOSTICS, INC.
K012250 07/17/2001 RAICHEM MULTI-ANALYTE CALIBRATOR HEMAGEN DIAGNOSTICS, INC.
K012649 08/13/2001 RAICHEM BUN RATE REAGENT HEMAGEN DIAGNOSTICS, INC.
K012668 08/13/2001 RAICHEM GLUCOSE UV REAGENT HEMAGEN DIAGNOSTICS, INC.
K022772 08/21/2002 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT HEMAGEN DIAGNOSTICS, INC.
K022767 08/21/2002 RAICHEM LIPID CALIBRATOR HEMAGEN DIAGNOSTICS, INC.
K003012 09/26/2000 RAICHEM PHOSPORUS REAGENT HEMAGEN DIAGNOSTICS, INC.
K023784 11/12/2002 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER HEMAGEN DIAGNOSTICS, INC.
K971046 03/21/1997 HANDIFLEX HANDIFLEX CORP.
K023676 11/01/2002 APPLANATION TONOMETER OPTILASA S.L.
K003375 10/30/2000 CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX TECNILATEX S.A.
K171550 05/26/2017 Sterile Latex Surgical Gloves, Powder Free Sanrea Healthcare Products Pvt Ltd
K143477 12/05/2014 Nitrile Patient Examination gloves, Powderfree, Blue color PRIMUS GLOVES PVT LIMITED
K171093 04/12/2017 STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE Sanrea Healthcare Products Pvt Ltd
K211952 06/23/2021 BTI Interna Narrow/Plus Dental Implant System UnicCa B.T.I. Biotechnology Institute, SL
K213106 09/24/2021 BTI Interna Dental Implant System UnicCa - Prosthetic Components B.T.I. Biotechnology Institute, SL.
K202825 09/24/2020 BTI Extra-Short Dental Implant System UnicCa B.T.I. Biotechnology Institute, S.L.
K092261 07/28/2009 DEFCON TSA/TSH DENTAL IMPLANT SYSTEM IMPLADENT, S.L.
K052046 07/29/2005 BLOOD PRESSURE METER, MODEL CH-432 CITIZEN WATCH CO., LTD.
K981202 04/02/1998 WATER FILLED GUM SOOTHER CORIUM CORP.
K212743 08/30/2021 MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System MedSchenker, Inc.
K213892 12/14/2021 Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine RB Health (US) LLC
K022941 09/03/2002 MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING ABBOTT LABORATORIES
K042290 08/24/2004 VACUUM ASSISTED CORE BIOPSY DEVICE SUROS SURGICAL SYSTEMS, INC.
K143191 11/06/2014 IntelliSense Drill McGinley Innovations
K001669 05/31/2000 HANGER CRANIAL BAND HANGER ORTHOPEDIC GROUP, INC.
K140007 01/02/2014 ABACUS TM SPACER SYSTEM SPINE WAVE, INC.
K132154 07/12/2013 CAPSURE PS SYSTEM SPINE WAVE, INC.
K122233 07/26/2012 CAPSURE(R) PS SYSTEM SPINE WAVE, INC.
K132403 08/01/2013 ANNEXTM ADJACENT LEVEL SYSTEM SPINE WAVE, INC.
K133207 10/18/2013 STAXX(R) SYSTEM SPINE WAVE, INC.
K170970 03/31/2017 Epilaser Epilady 2000 LLC
K980501 02/09/1998 SKINTONER SYSTEM FULLER RESEARCH CORP.
K955643 12/12/1995 ALARA IMAGING SYSTEM DENOPTIX, INC.
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K973703 09/26/1997 JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN ALLEGIANCE HEALTHCARE CORP.
K020995 03/28/2002 EFILM WORKSTATION WITH MODULES EFILM MEDICAL, INC.
K013631 11/05/2001 EFILM VIDEO EFILM MEDICAL, INC.
K001244 04/18/2000 BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D CITIZEN WATCH CO., LTD.
K973061 08/18/1997 CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) CITIZEN WATCH CO., LTD.
K984223 11/25/1998 BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 CITIZEN WATCH CO., LTD.
K061161 04/26/2006 BLOOD PRESSURE METER, MODEL CH-311B CITIZEN WATCH CO., LTD.
K973613 09/22/1997 CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER FOLEY & LARDNER
K971645 05/05/1997 REGANES SPINAL NEEDLE (VARIOUS) AVID N.I.T., INC.
K972554 07/08/1997 REGANES RADIONUCLIDE SEED MAGAZINE AVID N.I.T., INC.
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K983218 09/14/1998 N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE AVID N.I.T., INC.
K973638 09/24/1997 N.I.T., INC. NEEDLE GUIDING TEMPLATE AVID N.I.T., INC.
K092494 08/14/2009 GEL FILLED GUM SOOTHER LUV N' CARE, LTD.
K960023 01/02/1996 KIRSHNER WIRES (K-WIRE) & STEINMANN PINS PROMEX, INC.
K960405 01/29/1996 SPINAL NEEDLE PROMEX, INC.
K010400 02/12/2001 VACUUM ASSISTED CORE BIOPSY DEVICE PROMEX, INC.
K001132 04/10/2000 BONE BIOPSY NEEDLE PROMEX, INC.
K011270 04/26/2001 AUTOMATED CORE BIOPSY DEVICE PROMEX, INC.
K972865 08/04/1997 PROMEX ENT TISSUE REMOVAL SYSTEM PROMEX, INC.
K022634 08/08/2002 CO-AXIAL INTRODUCER NEEDLE PROMEX, INC.
K973184 08/25/1997 PROSTATE SEEDING NEEDLE PROMEX, INC.
K993435 10/12/1999 MANUAL BONE MARROW BIOPSY DEVICE PROMEX, INC.
K023450 10/15/2002 BIOPSY SITE TISSUE MARKER DEVICE PROMEX, INC.
K955168 11/13/1995 SURGICAL CUTTER PROMEX, INC.
K994272 12/20/1999 AUTOMATED CORE BIOPSY DEVICE PROMEX, INC.
K034021 12/24/2003 VACUUM ASSISTED CORE BIOPSY DEVICE SUROS SURGICAL SYSTEMS, INC.
K060618 03/08/2006 CIDEX ACTIVATED DIALDEHYDE SOLUTION JOHNSON & JOHNSON CO.
K051643 06/20/2005 STERRAD STERILIZER CYCLESURE TEST PACK ADVANCED STERILIZATION PRODUCTS
K061899 07/03/2006 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS
K042450 09/09/2004 STERRAD NX CHALLENGE PACK ADVANCED STERILIZATION PRODUCTS
K040048 01/12/2004 FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM FUJINON, INC.
K010311 02/01/2001 LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE EUROMI SA
K040518 02/27/2004 SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING SELECT FABRICATORS, INC.
K021055 04/01/2002 BUSSE UMBILICAL CORD CLAMP CUTTER BUSSE HOSPITAL DISPOSABLES, INC.
K071233 05/03/2007 XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM KUB TECHNOLOGIES, INC
K061293 05/09/2006 TELAHEART DIGITAL RECORDER NORTHEAST MONITORING, INC.
K091773 06/16/2009 FUJINON STERILE OVERTUBES FUJINON, INC.
K041903 07/14/2004 FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 FUJINON, INC.
K071977 07/17/2007 TARRY MEDICAL TEMPERATURE PROBES TARRY MEDICAL PRODUCTS, INC.
K042043 07/29/2004 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 FUJINON, INC.
K042076 08/02/2004 FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 FUJINON, INC.
K032432 08/06/2003 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER BUSSE HOSPITAL DISPOSABLES, INC.
K052243 08/17/2005 PROACT WITH GEL OR PROACT 1 PROACT INC.
K092723 09/04/2009 AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM SKELETAL DYNAMICS, LLC
K013218 09/26/2001 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K023384 10/08/2002 COOPERSURGICAL TRIAL TRANSFER CATHETER COOPER SURGICAL
K023383 10/08/2002 COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER COOPER SURGICAL
K023379 10/08/2002 COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER COOPER SURGICAL
K023382 10/08/2002 COOPERSURGICAL MALLEABLE SYTLET COOPER SURGICAL
K023465 10/15/2002 KENDRO HERACELL 240 INCUBATOR KENDRO LABORATORY PRODUCTS, L.P.
K063245 10/26/2006 ELUTIA COATED CLOSED SURGICAL WOUND DRAIN BACTERIN INTERNATIONAL INC.
K013672 11/06/2001 BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM AZARY TECHNOLOGIES LLC.
K993861 11/15/1999 FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K023930 11/25/2002 COOPERSURGICAL OOCYTE RECOVERY NEEDLES COOPERSURGICAL, INC.
K083510 11/26/2008 KUBTEC XPERT 20 KUB TECHNOLOGIES, INC
K960324 01/23/1996 HEMAGEN CRP 150 KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K971039 03/21/1997 HEMAGEN ANTI CARDIOLIPIN SCREEN HEMAGEN DIAGNOSTICS, INC.
K971909 05/23/1997 VIRGO AMA ELISA KIT HEMAGEN DIAGNOSTICS, INC.
K962276 06/13/1996 HEMAGEN ENA DSDNA KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K992224 07/01/1999 VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K992241 07/01/1999 VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K992243 07/01/1999 VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K962836 07/22/1996 HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K972812 07/28/1997 RAICHEM PREALBUMIN SPIA HEMAGEN DIAGNOSTICS, INC.
K944438 09/12/1994 HEMAGEN CMV IGG KIT HEMAGEN DIAGNOSTICS, INC.
K973822 10/07/1997 VIRGO ANCA SCREEN KIT HEMAGEN DIAGNOSTICS, INC.
K973824 10/07/1997 VIRGO PANCO KIT HEMAGEN DIAGNOSTICS, INC.
K970373 02/03/1997 RAICHEM RHEUMATOID FACTOR SPIA HENAGE DIAGNOSTICS, INC.
K002566 08/17/2000 LUMALITE CURE LIGHT, MODEL 2100 LUMALITE, INC.
K983227 09/15/1998 POWER BLOCK KREATIV, INC.
K962829 06/28/1996 HARMAC BALLOON ANGIOGRAPHIC CATHETER HARMAC MEDICAL PRODUCTS, INC.
K963074 06/28/1996 HARMAC QUADPOLAR MAPPING PACING CATHETER HARMAC MEDICAL PRODUCTS, INC.
K963073 06/28/1996 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET HARMAC MEDICAL PRODUCTS, INC.
K962833 06/28/1996 HARMAC TEMPORARY PACING CATHETER WITH BALLOON HARMAC MEDICAL PRODUCTS, INC.
K050889 04/06/2005 FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH CRS MEDICAL DIAGNOSTICS INC.
K000612 02/23/2000 ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE INRAD
K993785 11/08/1999 ULTRACLIP TISSUE MARKER INRAD
K955651 12/12/1995 MEDTRONIC SHERPA GUIDING CATHETER MEDTRONICS INTERVENTIONAL VASCULAR
K960983 03/11/1996 MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT MEDTRONICS INTERVENTIONAL VASCULAR
K180474 02/22/2018 TNI softFlow 50 TNI Medical AG
K972768 07/24/1997 BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM BLACKSTONE MEDICAL, INC.
K964919 12/09/1996 EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM EMERALD MEDICAL, INC.
K141256 05/14/2014 OKAMOTO STUDDED CONDOM OKAMOTO U.S.A., INC.


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