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175 FDA 510(k) clearances · Product code

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RecordFirmDate
TAC-TITE (TM) (K090128)Core Essence Orthopaedics, Inc.2009-03-19
DUAL NEEDLE SUTURE PASSER SYSTEM (K082518)Cayenne Medical, Inc.2009-01-16
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE (K082535)Surgical Devices, A Global Business Unit Covidien2008-12-01
MENISCAL CINCH (K073149)Arthrex, Inc.2008-02-11
ANCHORAGE CLOSURE DEVICE (K073096)Epitek, Inc.2008-02-07
NEOTRACT ANCHOR SYSTEM (K073651)Neotract, Inc.2008-02-01
CAPSEW PLICATION SYSTEM (K071796)Cayenne Medical, Inc.2007-10-19
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS (K072322)Smith & Nephew, Inc.2007-09-18
AXYA SUTURE WELDING SYSTEM AND KIT (K070253)Axya Medical, Inc.2007-07-11
ARTHREX FIBERWIRE (K071622)Arthrex, Inc.2007-07-03
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE (K070673)Teleflexmedical, Inc.2007-04-02
FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE (K063778)Teleflex Medical2007-02-09
G-PROX ENDOSCOPIC GRASPER (K061276)Usgi Medical2006-12-06
TUFFLEX POLYESTER SUTURE (K063194)Axya Medical, Inc.2006-12-04
CARDIOFLON, CARDIOXYL (K060163)Peters Surgical2006-10-11
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS (K062307)Anulex Technologies, Inc.2006-09-01
AXYAFLEX POLYESTER SUTURE (K060165)Axya Medical, Inc.2006-09-01
TENOLIG (K060367)Fournitures Hospitalieres Industrie2006-08-09
ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB (K061386)Anulex Technologies, Inc.2006-07-05
LARIAT LOOP APPLICATOR (K060721)Sentreheart2006-06-02
ALLOFIX ANCHOR (K053339)Musculoskeletal Transplant Foundation2006-03-16
MANI NEEDLE & SUTURE PACK (K050150)Mani, Inc.2005-12-05
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE (K052652)Smith & Nephew, Inc.2005-10-21
NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE (K041512)Sutures India Private Limited2005-06-02
MTF ALLOGRAFT ANCHOR (K042038)Musculoskeletal Transplant Foundation2004-12-23
ARTHREX SUTURE GRAFTING KIT (K041553)Arthrex, Inc.2004-12-10
UNIESTER C (K042286)United Medical Industries Co. , Ltd.2004-12-01
OPUS SPEEDSTITCH SUTURE DEVICE (K042031)Opus Medical, Inc.2004-10-19
ORTHOFIBER (K041894)Cp Medical2004-09-17
ARTHREX FIBERWIRE WITH SILK (K041589)Arthrex, Inc.2004-08-05
SMITH & NEPHEW ULTRABRAID SUTURE (K041216)Smith & Nephew, Inc.2004-06-07
DURABRAID SUTURE (K040789)Smith & Nephew, Inc.2004-06-04
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE (K040472)Teleflex Medical2004-03-15
LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 (K040232)Lsi Solutions2004-03-01
MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE (K033718)Arthrotek, Inc.2004-02-12
FORCE FIBER (K033654)Teleflex Medical2004-01-15
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 (K032245)Arthrex, Inc.2004-01-14
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM (K032901)Stryker Endoscopy2003-12-02
DEMETECH POLYESTER NONABSORBABLE SUTURE (K023030)Demetech Corp.2003-06-18
ARTHREX FIBERWIRE IN USP SIZES (K021434)Arthrex, Inc.2002-11-07
SAPH-LOOP LIGATING LOOP (K022410)Genzyme Biosurgery2002-08-20
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (K021019)Genzyme Corp.2002-06-18
SERRALESTER (K020902)Serral, S.A. DE C.V.2002-05-20
LIFESTITCH SUTURING DEVICE (K013990)Edwards Lifesciences, LLC2002-02-27
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 (K012923)Arthrex, Inc.2001-10-04
PREMICRON NONABSORBABLE PET SURGICAL SUTURE (K012201)Aesculap, Inc.2001-09-19
POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (K002172)Xiros Plc2001-08-28
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 (K010673)Arthrex, Inc.2001-05-14
GRAMS POLYESTER NONABSORBABLE SUTURE (K003590)Gramsmed, LLC2001-03-05
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (K001440)Genzyme Surgical Product (Genzyme Biosurgery)2000-11-13
POLYESTER NONABSORBABLE SURGICAL SUTURES URP (K001172)Cp Medical2000-06-23
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE (K001434)Genzyme Surgical Product (Genzyme Biosurgery)2000-06-12
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (K000540)Arc Medical Supplies (Beijing) Co, Ltd.2000-04-27
POLYESTER (K994000)Trading Consultants and Distributors Intl., Inc.2000-02-04
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES (K990952)United States Surgical, A Division of Tyco Healthc1999-04-01
PRE-THREADED ENDOBUTTON (K984550)Smith & Nephew, Inc.1999-03-01
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE (K990088)Aesculap, Inc.1999-02-10
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER (K972911)United States Surgical, A Division of Tyco Healthc1998-04-25
ENDOBUTTON CONTINUOUS LOOP (K980155)Smith & Nephew, Inc.1998-04-01
ACUFEX DOUBLE ARMED SUTURE NEEDLE (K970416)Smith & Nephew Endoscopy, Inc.1997-04-21
POLYESTER NONABSORBABLE SURGICAL SUTURES USP (K961925)R. K. Medical L. L. C.1996-07-29
EXPANDED BODY SUTURE (K961025)Medicinelodge, Inc.1996-04-15
USSC NONABSORBABLE SUTURES (K955747)United States Surgical, A Division of Tyco Healthc1996-02-27
ACUFEX ENDOBUTTON TAPE (K952535)Acufex Microsurgical, Inc.1996-02-08
SURGIBOND (K943221)Sutures , Ltd.1994-12-05
SUTULENE (K943220)Sutures , Ltd.1994-12-05
POLYVIOLENE SURGICL SUTURE (K943949)Look, Inc.1994-11-10
SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER (K931916)Surgimetrics International, Ltd.1994-03-03
SUTURE NONABSORBABLE- SILK, POLYESTER (K932038)Surgical Specialties, Inc.1994-01-07
TI-CRON AND DACRON SUTURES (K930591)Davis & Geck, Inc.1993-12-17
POLYVIOLENE SUTURE-REVISED LABELING (K926167)Look, Inc.1993-12-17
LUKENS SILK SURGICAL SUTURE (K930942)Lukens Medical Corp.1993-12-17
BRAIDED POLYESTER SURGICAL SUTURE (K930945)Lukens Medical Corp.1993-12-17
SILK SUTURES (K930590)Davis & Geck, Inc.1993-12-17
MEDSURG MARSHMALLOW TRAY (K920421)Medsurg Industries, Inc.1993-12-13
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