FDA 510(k) Applications Submitted by Greg Holland

FDA 510(k) Number Submission Date Device Name Applicant
DEN130012 01/02/2013 FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
K120119 01/17/2012 SUNMED GUIDE WIRE SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
K000120 01/18/2000 PRO-TORQ MICRO MOTORS, INC.
K980474 02/06/1998 TELICAM DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
K980525 02/11/1998 UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD MARUKIN SHOYU CO., LTD.
K010562 02/26/2001 ALPHA DX SYSTEM FIRST MEDICAL, INC.
K010589 02/27/2001 MICROWAVAE DELIVERY SYSTEM #MW2000 MW MEDICAL, INC.
K040527 03/01/2004 LOW PROFILE LUTHER SAFETY HUBER LUTHER NEEDLESAFE PRODUCTS, INC.
K050586 03/07/2005 LEONE IMPLANT SYSTEM LEONE SPA
K990845 03/15/1999 MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 ADVANCED SPINE FIXATION SYSTEMS, INC.
K020880 03/18/2002 MARKNEW PRODUCTS ACUPUNCTURE NEEDLES MARKNEW PRODUCTS
K010884 03/23/2001 TITANIUM COMPRESSION ANCHOR SYSTEM ANCHOR MEDICAL TECHNOLOGIES
K981157 03/31/1998 STABLE FLOW CMED
K991104 04/01/1999 MICROTOOLS CONCEPTION TECHNOLOGY, INC.
K100913 04/01/2010 IQVITALS AND IQVITALS SYSTEM BRENTWOOD MEDICAL TECHNOLOGY CORP.
K991322 04/19/1999 ENHANCE-S PLUS CONCEPTION TECHNOLOGY, INC.
K991391 04/21/1999 PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF ADVANCED REPRODUCTIVE TECHNOLOGIES
K991396 04/21/1999 WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L SAGE BIOPHARMA
K991393 04/21/1999 HYALURONIDASE, 80 U/ML SAGE BIOPHARMA
K991392 04/21/1999 HUMAN SERUM ALBUMIN ADVANCED REPRODUCTIVE TECHNOLOGIES
K991390 04/21/1999 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI SAGE BIOPHARMA
K991388 04/21/1999 ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M PACIFIC ANDROLOGY, INC.
K991381 04/21/1999 PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA PACIFIC ANDROLOGY, INC.
K991380 04/21/1999 OIL FOR TISSUE CULTURE ADVANCED REPRODUCTIVE TECHNOLOGIES
K991379 04/21/1999 QUINN'S SPERM WASHING MEDIUM ADVANCED REPRODUCTIVE TECHNOLOGIES
K991378 04/21/1999 PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED SAGE BIOPHARMA
K971499 04/25/1997 FEMALE EXTERNAL URINARY COLLECTION POUCH MEDIQUEST, INC.
K991456 04/26/1999 MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 MICROWAVE MEDICAL, INC.
K111222 05/02/2011 MRI-Q SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
K021520 05/10/2002 EMT-CPAP EMERGENCY MEDICAL TECHOLOGY
K141234 05/13/2014 ODISSEY TISSUE OXIMETER VIOPTIX, INC.
K121579 05/30/2012 EK DELIVERY DEVICE TDAK MEDICAL, INC
K981948 06/03/1998 APOLLO 95E DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
K992012 06/15/1999 WILTSE SYSTEM ADVANCED SPINE FIXATION SYSTEMS, INC.
K022078 06/26/2002 SOLA, COUNTER-PULSATION, MODEL SECP-S SOLA MEDICAL DEVICES, LLC
K131910 06/26/2013 MPP MARC PRO
K032012 06/30/2003 HOMOCYSTEINE MICROTITER PLATE ASSAY DIAZYME LABORATORIES
K032102 07/08/2003 VERTELINK KOBRA SPINAL FIXATION SYSTEM VERTELINK CORPORATION
K972587 07/11/1997 ELECTROCARDIOGRAPHS DR. LEE CO., LTD.
K972603 07/11/1997 ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B DR. LEE CO., LTD.
K122035 07/11/2012 HEPAFAT SCAN RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
K032178 07/16/2003 RHYTHM TOUCH Q 2-WAY SHOCKIM ENTERPRISES, LTD.
K012280 07/19/2001 TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 TRIAGE MEDICAL INC
K982578 07/23/1998 QUANTI-TEST SYSTEM PANATREX, INC.
K032427 08/06/2003 FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM MERIDAN MEDICAL
K982793 08/10/1998 PIEZO TRONIC ADVANCED MEDICAL DEVICES, INC.
K052195 08/11/2005 EZ-MIO MANUAL DRIVER VIDACARE CORPORATION
K052207 08/12/2005 ACCUREX GLUCOSE TEST STRIP INCLINE MEDICAL, LLC
K012817 08/22/2001 HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED TRIAGE MEDICAL INC
K222606 08/29/2022 V-HYADASE VITROMED GmbH
K002836 09/12/2000 MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE SAGE BIOPHARMA
K032885 09/16/2003 VIDAPORT INTRAOSSEOUS INFUSION SYSTEM VIDACARE CORPORATION
K013118 09/18/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC.
K993140 09/20/1999 WATER FOR TISSUE CULTURE, MODELS 1500 CONCEPTION TECHNOLOGIES
K032935 09/22/2003 EPI-SCAN, MODEL P 100 EDX EPI-SCAN, INC.
K042657 09/28/2004 VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 VIOPTIX, INC.
K033147 09/30/2003 CLEARTOOTH DIGITAL X-RAY SYSTEM CLEARTOOTH ELECTRONICS, INC.
K213263 09/30/2021 OnyxCeph Image Instruments GmbH
K213293 10/01/2021 V-HEPES PLUS Vitromed Langenfeld
K223117 10/03/2022 V-SPERM WASH Vitromed GmbH
K093176 10/08/2009 MED-LOK STA-MED, LLC
K993554 10/20/1999 YEASTEST DIAGNOSTIC MARKERS, INC.
K993895 11/16/1999 OPTIRAD PERMEDICS, INC.
K993941 11/19/1999 UBAS MARUKIN DIAGNOSTICS
K955510 12/04/1995 X6000D SILENT SUN LIGHT SOURCE PRODUCTS FOR MEDICINE
K014024 12/06/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC.
K103640 12/13/2010 MIDMARK IQECG BRENTWOOD MEDICAL TECHNOLOGY CORP.
K043490 12/17/2004 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE VIDACARE CORPORATION
K043506 12/20/2004 ACUPUNCTURE NEEDLES MARKNEW PRODUCTS
K133983 12/27/2013 INTRA. OX HANDHELD TISSUE OXIMETER VIOPTIX INC.
K974892 12/30/1997 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 ACUTEK ADHESIVE SPECIALTIES, INC.
K974890 12/30/1997 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 ACUTEK ADHESIVE SPECIALTIES, INC.
K974891 12/30/1997 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 ACUTEK ADHESIVE SPECIALTIES, INC.
K012818 08/22/2001 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX TRIAGE MEDICAL INC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact