FDA 510(k) Applications Submitted by KATHLEEN M ,CLOUGH

FDA 510(k) Number Submission Date Device Name Applicant
K080175 01/24/2008 NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 DATASCOPE CORP., PATIENT MONITORING DIVISION
K091068 04/14/2009 ACCUTORR V MONITOR, MODEL 0998-00-2000 DATASCOPE CORP., PATIENT MONITORING DIVISION
K091834 06/22/2009 PASSPORT V MONITOR, MODEL 0998-00-6100 DATASCOPE CORP., PATIENT MONITORING DIVISION
K071805 07/02/2007 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX DATASCOPE CORP.
K062098 07/24/2006 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX DATASCOPE CORP.
K062754 09/14/2006 GAS MODULE SE, MODEL 0998-00-0481-02 DATASCOPE CORP.
K173717 12/05/2017 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation
K990454 02/12/1999 BIO-INTERFERENCE SCREW INNOVASIVE DEVICES, INC.
K050403 02/17/2005 SPYGLASS DIRECT VISULATION PROBE BOSTON SCIENTIFIC CORP.
K030769 03/11/2003 ULTRAFLEX PRECISION COLONIC STENT BOSTON SCIENTIFIC CORP.
K020824 03/14/2002 SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 BOSTON SCIENTIFIC CORP.
K992377 07/15/1999 RC TACK INNOVASIVE DEVICES, INC.
K992458 07/23/1999 RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 INNOVASIVE DEVICES, INC.
K042065 08/02/2004 WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM BOSTON SCIENTIFIC CORP.
K012752 08/16/2001 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE BOSTON SCIENTIFIC CORP.
K012883 08/28/2001 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM BOSTON SCIENTIFIC CORP.
K983056 09/01/1998 INNOVASIVE TIBIAL FASTENER INNOVASIVE DEVICES, INC.
K032930 09/22/2003 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORP.
K993975 11/24/1999 ABSOLUTE ABSORBABLE INTERFERENCE SCREW INNOVASIVE DEVICES, INC.
K984490 12/17/1998 SUTURELESS ANCHOR INNOVASIVE DEVICES, INC.
K994269 12/20/1999 TITAN RC TACK INNOVASIVE DEVICES, INC.
K123683 11/30/2012 NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR AEROCRINE AB
K191177 05/02/2019 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Smith and Nephew, Inc.
K171794 06/16/2017 Smith & Nephew 25 Fluid Management System Smith & Nephew, Inc.
K221929 07/01/2022 Smith+Nephew INTELLIO Tablet Smith+Nephew
K132636 08/22/2013 DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM SMITH & NEPHEW, INC.
K102544 09/03/2010 SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY SMITH & NEPHEW INC., ENDOSCOPY DIV.
K102660 09/15/2010 BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS SMITH & NEPHEW ENDOSCOPY, INC.
K103309 11/10/2010 OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS SMITH & NEPHEW ENDOSCOPY, INC.
K080154 01/23/2008 ACUITY UNIVERSAL CUTTER CARDIAC PACEMAKERS, INC.
K061453 05/25/2006 HI-TORQUE WHISPER VIEW GUIDE WIRE GUIDANT CORP.
K093969 12/23/2009 ACUITY BREAK-AWAY GUIDE CATHETER CARDIAC PACEMAKERS, INC.
K151562 06/10/2015 Resultz Lice & Egg Removal Kit Piedmont Pharmaceuticals, LLC
K955903 12/29/1995 SELFCARE EARLY PREGNANCY TEST CAMBRIDGE DIAGNOSTICS IRELAND, LTD.
K960436 01/31/1996 SELFCARE EARLY PREGNANCY TEST SELFCARE, INC.
K970314 01/24/1997 SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS BECKMAN INSTRUMENTS, INC.
K965108 12/20/1996 SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT BECKMAN INSTRUMENTS, INC.
K040262 02/04/2004 DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION
K991235 04/12/1999 SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) LUDLOW TECHNICAL PRODUCTS
K003511 11/14/2000 KENDALL-LTP TURNER SAVE-A-LINE THE LUDLOW COMPANY, LP
K103033 10/13/2010 TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX ZIMMER TRABECULAR METAL TECHNOLOGY
K012218 07/16/2001 LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES THE LUDLOW COMPANY LP
K960356 01/25/1996 POSTERIOR ANNULOPLASTY BAND (MODEL 607) THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG


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