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1,463 FDA 510(k) clearances · Device class

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RecordFirmDate
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19
ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441)Bio-Detek, Inc.2014-10-10
ZOLL X SERIES (K133484)Zoll Medical Corp2014-08-01
ZOLL X SERIES (K133269)Zoll Medical Corporation, World Wide Headquarters2014-05-22
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K131525)Defibtech, LLC2014-04-24
POWERHEART G5 AED (K122758)Cardiac Science Corporation2014-02-12
HEART SYNC (K131550)Heart Sync, Inc.2013-12-06
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K130684)Philips Medical Systems2013-10-18
HEART SYNC (K131494)Heart Sync, Inc.2013-09-16
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454)Physio-Control, Inc.2013-08-21
HEARTSINE SAMARITAN PAD 350P (K123881)Heartsine Technologies, Inc.2013-07-11
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS (K130006)Cook Biotech Incorporated2013-04-05
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST (K130153)Philips Medical Systems2013-03-12
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K113787)Defibtech, LLC2013-01-04
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM (K122459)Boston Scientific Corporation2012-12-13
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K121853)Defibtech, LLC2012-12-13
ZOLL SUREPOWER SINGLE BAY CHARGER (K122839)ZOLL Medical Corporation2012-12-13
EXTENDED LIFE BATTERY (K120350)Aed Battery Exchange, LLC2012-11-01
ZOLL FULLY AUTOMATIC AED PLUS (K120406)Zoll Medical Corporation, World Wide Headquarters2012-10-26
LIFEPAK 1000 DEFIBRILLATOR (K122600)Physio-Control, Inc.2012-10-11
PROFEMUR Z REVISION HIP STEM (K122778)Wrightmedicaltechnologyinc2012-10-11
ZOLL R SERIES (K120907)Zoll Medical Corporation, World Wide Headquarters2012-09-25
HEART SYNC PEDIATRIC PHYSIO AED PAD (K120536)Heart Sync, Inc.2012-08-06
DYNASTY BIOFOAM SHELL (K121544)Wrightmedicaltechnologyinc2012-07-30
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (K121612)American Medical Systems2012-07-20
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271)Biomet Manufacturing, Inc.2012-05-18
ZOLL PROPAQ MD (K112761)Zoll Medical Corporation, World Wide Headquarters2012-04-25
ZOLL X SERIES (K112432)Zoll Medical Corporation, World Wide Headquarters2012-03-21
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825)Philips Medical Systems2012-02-16
CONSERVE THIN SHELL (K113322)Wrightmedicaltechnologyinc2012-02-03
PRESERVE HIP STEM (K112080)Wrightmedicaltechnologyinc2011-12-28
PROFEMUR GLADIATOR HA HIP STEM (K112150)Wrightmedicaltechnologyinc2011-11-23
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019)Wrightmedicaltechnologyinc2011-11-10
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K111693)Philips Medical Systems2011-10-28
AMS ELEVATE PC (K112842)American Medical Systems, Inc.2011-10-25
GLADIATOR HIP STEM (K111910)Wrightmedicaltechnologyinc2011-10-14
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836)Zimmer GmbH2011-10-07
TAPERLOC COMPLETE MICROPLASTY STEM (K110400)Biomet Manufacturing Corp2011-09-30
LITE PELVIC FLOOR REPAIR KITS (K103426)Boston Scientific Corp2011-09-14
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386)Coloplast Corp.2011-09-08
PROFEMUR(R) E CEMENTLESS HIP STEM (K111698)Wrightmedicaltechnologyinc2011-08-19
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699)Wrightmedicaltechnologyinc2011-08-19
ZOLL E SERIES (K111594)Zoll Medical Corporation, World Wide Headquarters2011-08-17
SURELIFT PROLAPSE SYSTEM (K102815)Neomedic International2011-07-07
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS (K102496)Cardiac Science Corporation2011-06-09
ONESTEP PEDIATRIC MFE'S (K110978)ZOLL Medical Corporation2011-05-13
GLADIATOR PLASMA CLASSIC HIP STEM (K110399)Wrightmedicaltechnologyinc2011-05-10
CONSERVE BIO FOAM SHELL (K110029)Wrightmedicaltechnologyinc2011-04-19
ONESTEP ADULT MULTI-FUNCTION ELECTRODE (K110742)ZOLL Medical Corporation2011-04-13
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110526)ZOLL Medical Corporation2011-03-25
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567)Physio-Control, Inc.2011-03-22
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110361)Zoll Medical Corporation, World Wide Headquarters2011-03-08
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110154)Zoll Medical Corporation, World Wide Headquarters2011-02-17
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110168)Zoll Medical Corporation, World Wide Headquarters2011-02-17
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (K103186)Leonhard Lang GmbH2011-02-08
TAPERLOC COMPLETE, SIZE 5 AND 6 (K103755)Biomet Manufacturing Corp2011-01-21
LIFEPAK 12 (K102972)Physio-Control, Inc.2010-12-22
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS (K102565)Wrightmedicaltechnologyinc2010-12-22
ARCOS INTERLOCKING DISTAL STEMS (K100469)Biomet Manufacturing Corp2010-12-07
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 (K100565)Bio-Detek, Inc.2010-11-16
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE (K091561)ZOLL Medical Corporation2010-09-23
TAPERLOC COMPLETE (K101086)Biomet, Inc.2010-09-03
COMPRESS ANTI-ROTATION SPINDLES (K101475)Biomet Manufacturing Corp2010-06-18
RINGLOC + HYBRID ACETABULAR SYSTEM (K093235)Biomet, Inc.2010-04-30
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED (K092391)Concord Medical Products2010-04-01
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; (K092331)Encore Medical L.P.2010-03-03
ZOLL E SERIES WITH CPRREADYCHARGE (K091265)Zoll Medical Corporation, World Wide Headquarters2009-12-23
ZOLL E SERIES WITH SPCO/SPMET OPTION (K092598)Zoll Medical Corporation, World Wide Headquarters2009-12-03
ZIMMER MMC CUP (K091003)Zimmer GmbH2009-11-24
METASUL TAPER LINERS, METASUL FEMORAL HEADS (K091973)Zimmer GmbH2009-11-17
BIOMET MODULAR FEMORAL REVISION SYSTEM (K090757)Biomet, Inc.2009-09-25
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (K090989)Zoll Medical Corp2009-09-23
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (K091943)Cardiac Science Corporation2009-09-10
PROFEMUR HIP SYSTEM MODULAR NECKS (K091423)Wrightmedicaltechnologyinc2009-08-25
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A (K091548)Amco International Manufacturing & Design, Inc.2009-08-07
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K081259)Defibtech, LLC2009-06-15
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
ASCEND (K083722)Caldera Medical, Inc.2009-03-31
REVELATION STEM, MODEL 427-21/42-080/180 (K083651)Encore Medical L.P.2009-03-13
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937)Physio-Control, Inc.2009-03-11
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING (K081081)Zoll Medical Corporation, World Wide Headquarters2009-03-09
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924)Wrightmedicaltechnologyinc2009-03-06
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K083642)DePuy Orthopaedics, Inc.2009-03-06
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K083839)C.R. Bard, Inc.2009-01-15
AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677)American Medical Systems, Inc.2008-12-23
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Every clearance here is in the API, with alerts when new ones post.