FDA 510(k) Applications Submitted by JAMES HO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K182986 |
10/29/2018 |
Boston Keratoprosthesis, Type I Lucia |
Massachusetts Eye and Ear Infirmary d/b/a Boston |
| K112573 |
09/06/2011 |
EZSLEEP SLEEP QUALITY RECORDER |
PLATINUM TEAM CO., LTD |
| K070874 |
03/29/2007 |
ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR |
ARTHRO KINETICS INC. |
| K171751 |
06/13/2017 |
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module |
Capsule Technologie, SAS |
| K981313 |
04/10/1998 |
SEQUENCER |
IMPAC MEDICAL SYSTEMS, INC. |
| K122105 |
07/17/2012 |
SMI CARDIOVASCULAR PATCH |
SOLINAS MEDICAL INC |
| K990960 |
03/22/1999 |
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) |
PERIMED, INC. |
| K120506 |
02/21/2012 |
PARIETEX COMPOSITE VENTRAL PATCH |
SOFRADIM PRODUCTION |
| K120605 |
02/28/2012 |
PERMACOL SURGICAL IMPLANT |
Covidien LLC |
| K110663 |
03/08/2011 |
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) |
SOFRADIM PRODUCTION |
| K110816 |
03/24/2011 |
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) |
SOFRADIM PRODUCTION |
| K110815 |
03/24/2011 |
PARIETEX OPTIMIZED COMPOSTIE MESH |
SOFRADIM PRODUCTION |
| K120897 |
03/26/2012 |
PROGRIP LAPARSCOPIC SELF-FIXATING MESH |
SOFRADIM PRODUCTION |
| K121139 |
04/16/2012 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
| K101519 |
06/02/2010 |
PARIETEX PLUG AND PATCH |
SOFRADIM PRODUCTION |
| K123479 |
11/13/2012 |
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH |
SOFRADIM PRODUCTION |
| K103682 |
12/17/2010 |
PARIETEX PROGRIP |
SOFRADIM PRODUCTION |
| K100102 |
01/13/2010 |
CS-SERIES-FP |
OMEGA MEDICAL IMAGING, INC. |
| K093572 |
11/18/2009 |
R650 QDASM COLLIMATOR |
OMEGA MEDICAL IMAGING, INC. |
| K110316 |
02/03/2011 |
INFOSEND GSM |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K040506 |
02/27/2004 |
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K050904 |
04/11/2005 |
CPAP HUMIDIFIER, MODEL HC238JHU |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K081029 |
04/11/2008 |
SLEEPSTYLE 200 AUTO SERIES HC254 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K040941 |
04/12/2004 |
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K121597 |
05/31/2012 |
ESON NASAL MASK |
FISHER & PAYKEL HEALTHCARE LIMITED |
| K041900 |
07/14/2004 |
HC604 CPAP HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K092846 |
09/15/2009 |
AIRVO SERIES HUMIDIFIERS |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K033087 |
09/29/2003 |
ORACLE ORAL MASK, MODEL HC451A |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K094040 |
12/30/2009 |
F&P ICON SERIES CPAP |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K210223 |
01/28/2021 |
Transcutaneous Electrical Nerve Stimulator |
Top-Rank Health Care Co.,Ltd. |
| K050092 |
01/14/2005 |
R605 FACS COLLIMETER |
OMEGA MEDICAL IMAGING, INC. |
| K070834 |
03/27/2007 |
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) |
OMEGA MEDICAL IMAGING, INC. |
| K062647 |
09/06/2006 |
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 |
OMEGA MEDICAL IMAGING, INC. |
| K142057 |
07/29/2014 |
INFIX CANNULATED SCREW SYSTEM |
INFIX MEDICAL LLC |
| K040018 |
01/06/2004 |
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 |
BOSTON SCIENTIFIC CORP. |
| K040148 |
01/23/2004 |
RESOLUTION HEMOSTASIS CLIPPING DEVICE |
BOSTON SCIENTIFIC CORP. |
| K040447 |
02/20/2004 |
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 |
BOSTON SCIENTIFIC CORP. |
| K041606 |
06/15/2004 |
EXTRACTOR RX RETRIEVAL BALLOON |
BOSTON SCIENTIFIC CORP. |
| K022059 |
06/25/2002 |
MICROVASIVE PULMONARY GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
| K012864 |
08/27/2001 |
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 |
BOSTON SCIENTIFIC CORP. |
| K162755 |
09/30/2016 |
Picocare |
WON TECH CO., LTD. |
| K971200 |
04/01/1997 |
W.A. |
W.A. RUBBERMATE CO., LTD. |
| K000299 |
01/31/2000 |
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D |
BIOMEDEX, INC. |
| K961104 |
03/20/1996 |
NOTEBOOK IMAGER |
DIGIRAD CORP. |
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