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

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RecordFirmDate
9131 DEFIBRILLATION ELECTRODES (K082090)Cardiac Science Corporation2008-12-12
ZOLL R SERIES BLS DEFIBRILLATOR (K081828)ZOLL Medical Corporation2008-12-09
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM (K082387)American Medical Systems2008-12-04
DEPUY ASPHERE M-SPEC HEAD (K082585)DePuy Orthopaedics, Inc.2008-12-04
ZOLL E SERIES WITH INTIBATION ASSIST OPTION (K080903)ZOLL Medical Corporation2008-12-04
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE (K082730)American Medical Systems, Inc.2008-11-26
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 (K082861)Amco International Manufacturing & Design, Inc.2008-11-25
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS (K082446)Biomet, Inc.2008-10-15
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE (K081710)American Medical Systems2008-10-15
AVAULTA SUPPORT SYSTEM (K082571)C.R. Bard, Inc.2008-09-30
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (K081371)Leonhard Lang GmbH2008-09-24
PINNACLE PELVIC FLOOR REPAIR KIT II (K081048)Boston Scientific Corp2008-08-22
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (K073499)Zimmer, Inc.2008-08-07
LIFEPAK 20E (K073089)Physio-Control, Inc.2008-07-29
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM (K080991)DePuy Orthopaedics, Inc.2008-07-02
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS (K071512)ETHICON, Inc.2008-05-15
PROFEMUR LX 5/8 COATED HIP STEM (K081090)Wrightmedicaltechnologyinc2008-05-15
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM (K081007)Zimmer, Inc.2008-05-06
ZOLL E SERIES DEFIBRILLATOR (K072923)Zoll Medical Corporation, World Wide Headquarters2008-04-24
ZOLL E SERIES 12SL, ANALYSIS OPTION (K080232)Zoll Medical Corporation, World Wide Headquarters2008-04-23
LIFE+CEL OR LIFECEL BATTERY (K073716)Amco International Manufacturing & Design, Inc.2008-04-11
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM (K080185)American Medical Systems, Inc.2008-04-10
PROFEMUR LX REVISION 5/8 COATED HIP STEM (K080663)Wrightmedicaltechnologyinc2008-04-08
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS (K073637)Biomet Manufacturing Corp2008-03-20
SPINAL SPHERE SYSTEM (K073274)Life Spine2008-03-17
ZIMMER POROLOCK MIS STEM (K071723)Zimmer GmbH2008-03-07
HEART SYNC, MODELS C-100 AND T-100 (K080421)Heart Sync, LLC2008-02-29
PHILIPS HEARTSTART SMARTPADS III (K072812)Philips Medical Systems2008-02-26
DEPUY ASR 300 ACETABULAR CUP SYSTEM (K073413)DePuy Orthopaedics, Inc.2008-01-30
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 (K072596)Amco International Manufacturing & Design, Inc.2008-01-24
I-PAD (K062970)Cu Medical Systems, Inc.2008-01-22
PEEK SPINAL SPHERES (K073105)Interbody Innovations, Llp2008-01-03
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES (K072951)Sofradim Production2007-12-19
PINNACLE PELVIC FLOOR REPAIR KITS (K071957)Boston Scientific Corp2007-11-08
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE (K072430)ZOLL Medical Corporation2007-11-06
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS (K072233)Leonhard Lang GmbH2007-10-05
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES (K071856)Zimmer, Inc.2007-07-30
SPINAL SPHERES (K062992)Interbody Innovations, Llp2007-07-27
DYNASTY ACETABULAR SYSTEM (K070785)Wrightmedicaltechnologyinc2007-07-11
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO (K071025)Zoll Medical Corporation, World Wide Headquarters2007-06-22
ZOLL E SERIES WITH SEE-THRU CPR (K070455)Zoll Medical Corporation, World Wide Headquarters2007-04-26
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 (K070221)Encore Medical L.P.2007-04-04
SPINAL STABILIZING SPHERE SYSTEM (K063139)Biomet Spine2007-04-04
ECHO BI-METRIC PRESS-FIT STEMS (K070274)Biomet Manufacturing Corp2007-04-03
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K063712)C.R. Bard, Inc.2007-03-12
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS (K062994)Biomet Manufacturing Corp2007-03-09
DEPUY ASR TAPER SLEEVE ADAPTER (K070359)DePuy Orthopaedics, Inc.2007-03-06
ZOLL M SERIES WITH REAL CPR HELP (K062537)ZOLL Medical Corporation2007-02-28
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS (K063562)ETHICON, Inc.2007-02-26
ALTRA FX HIP SYSTEM (K063614)Biomet Manufacturing Corp2007-02-20
LIFEPAK 12 DEFIBRILLATOR/MONITOR (K063510)Medtronic Emergency Response Systems, Inc.2007-01-26
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY (K063251)Zimmer, Inc.2007-01-24
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) (K062998)Biomet Manufacturing Corp2007-01-19
HEARTSTART MRX, MODELS M3535A OR M3536A (K063375)Philips Medical Systems2007-01-11
MODIFICATION TO: SATELLITE SPINAL SYSTEM (K060415)Medtronic Sofamor Danek2007-01-05
LIFEPAK 20 DEFIBRILLATOR/ MONITOR (K063119)Medtronic Emergency Response Systems, Inc.2006-12-22
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K062426)DePuy Orthopaedics, Inc.2006-12-15
ZOLL E SERIES WITH REAL CPR HELP (K062177)ZOLL Medical Corporation2006-12-13
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 (K052465)Heartsine Technologies, Inc.2006-12-12
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 (K063414)Encore Medical L.P.2006-12-12
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (K061844)Wrightmedicaltechnologyinc2006-12-06
HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233)Philips Medical Systems North America, Inc.2006-11-22
ALTRA PRESS-FIT HIP SYSTEM (K063002)Biomet Manufacturing Corp2006-10-31
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT (K062995)Biomet Manufacturing Corp2006-10-31
DUPUY S-ROM STD HIP STEM PROSTHESIS (K061221)DePuy Orthopaedics, Inc.2006-08-28
ZOLL R SERIES DEFIBRILLATOR (K060559)ZOLL Medical Corporation2006-08-17
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707)Philips Medical Systems2006-08-11
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS (K061423)Biomet Manufacturing Corp2006-07-27
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
MODIFICATION TO POWERHEART ECD (K060934)Cardiac Science Corporation2006-05-15
PROFEMUR TL HIP STEM (K060358)Wrightmedicaltechnologyinc2006-05-10
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL (K060356)Wrightmedicaltechnologyinc2006-04-18
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS (K053536)Zimmer GmbH2006-03-16
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K052057)Medtronic Emergency Response Systems, Inc.2006-02-17
PROFEMUR XTR HIP STEM (K052915)Wrightmedicaltechnologyinc2006-01-27
PROFEMUR LX HIP STEM (K053588)Wrightmedicaltechnologyinc2006-01-13
POWERHEART ECD (K052316)Cardiac Science, Inc.2006-01-03
ENCORE CLP OFFSET TOTAL HIP SYSTEM (K052320)Encore Medical Corporation2005-12-30
MENTOR NOVASILK MESH (K053414)Mentor Corp.2005-12-27
LIFEPAK, MODEL 1000 (K042404)Medtronic Emergency Response Systems, Inc.2005-12-22
POROUS TITANIUM ACETABULAR AUGMENTS (K052888)Biomet Manufacturing Corp2005-12-06
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (K052161)Cardiac Science, Inc.2005-10-21
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A (K051632)Philips Medical Systems2005-10-05
POROUS COATED ACETABULAR COMPONENTS (K050124)Biomet, Inc.2005-10-04
LINEAGE HA ACETABULAR SHELLS (K043099)Wrightmedicaltechnologyinc2005-09-29
SATELLITE SPINAL SYSTEM (K051320)Medtronic Sofamor Danek2005-09-09
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134)Philips Medical Systems2005-09-08
PROFEMUR RENAISSANCE HIP STEM (K051995)Wrightmedicaltechnologyinc2005-08-22
CONSERVE TOTAL FEMORAL HEAD (K051348)Wrightmedicaltechnologyinc2005-08-19
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (K040627)DePuy Orthopaedics, Inc.2005-08-05
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (K043547)Biomet, Inc.2005-08-05
UGYTEX SUAL KNIT MESH (K051503)Sofradim Production2005-08-05
ZOLL M SERIES 12SL ANALYSIS OPTION (K051475)ZOLL Medical Corporation2005-06-24
BALANCE HIP SYSTEM (K050251)Biomet, Inc.2005-05-27
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES (K051076)ZOLL Medical Corporation2005-05-13
PROCOTYL-E ACETABULAR SYSTEM (K043073)Wrightmedicaltechnologyinc2005-05-04
ZOLL E SERIES DEFIBRILLATOR (K042007)Zoll Medical Corp2005-04-07
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 (K050355)Tissue Science Laboratories, Plc2005-03-09
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004)Philips Medical Systems2005-02-25
ZOLL AED PRO EXTERNAL DEFIBRILLATOR (K041892)ZOLL Medical Corporation2005-02-04
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Every clearance here is in the API, with alerts when new ones post.