meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
25
Latest Decision
2004-03-01

Clearances · page 73 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040232 LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 Lsi Solutions GAT Class II 2004-03-01
K033814 BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 C.R. Bard, Inc. FTL Class II 2004-03-01
K022894 EPICOR MEDICAL ABLATION SYSTEM Epicor Medical, Inc. NTB Class II 2004-02-26
K033981 SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 Smith & Nephew, Inc. GEI Class II 2004-02-25
K033053 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2004-02-25
K033232 COLORADO MICRODISSECTION NEEDLE Stryker Corp. GEI Class II 2004-02-25
K033259 LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 Light Age, Inc. GEX Class II 2004-02-25
K033564 POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 Kanam Latex Industries Pvt. , Ltd. KGO Class I 2004-02-24
K040219 COBRA SURGICAL PROBE Boston Scientific Corp GEI Class II 2004-02-24
K034015 EARLOOP PROCEDURE MASK Medipack Medical Packaging Mfg. Co. FXX Class II 2004-02-20
K033962 LAD (EPITURE EASYTOUCH), MODEL LAD-08 Norwood Abbey , Ltd. GEX Class II 2004-02-20
K040104 COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 Boston Scientific Corp GEI Class II 2004-02-18
K034039 SIS PLASTIC SURGERY MATRIX Cook Biotech, Inc. FTM Class II 2004-02-18
K033354 FEMTEC LASER MICROKERATOME 20/10 Perfect Vision Optische Gerate GmbH GEX Class II 2004-02-18
K033205 MANOA BREAST BIOPSY SYSTEM Manoa Medical, Inc. GEI Class II 2004-02-18
K040239 SUPRAFLOW CONSOLE Neomedix Corp. BTA Class II 2004-02-17
K040062 LEVIA PHOTOTHERAPY SYSTEM Lerner Medical Devices, Inc. FTC Class II 2004-02-13
K033718 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE Arthrotek, Inc. GAT Class II 2004-02-12
K034030 APOGEE ELITE Cynosure, Inc. GEX Class II 2004-02-09
K033089 HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM Gyrus Ent LLC GEI Class II 2004-02-05
K032631 INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) Lac Mac, Ltd. FYA Class II 2004-02-05
K033652 MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT Zimmer, Inc. GEI Class II 2004-02-04
K033942 THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2004-02-04
K032969 HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE Helica Instruments, Ltd. GEI Class II 2004-02-04
K040024 SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 Power Medical Interventions, Inc. GDW Class II 2004-02-04
K040038 CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G Ethicon Endo-Surgery, Inc. GDW Class II 2004-02-04
K030523 WATERLASE Biolase Technology, Inc. GEX Class II 2004-01-30
K033447 CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 Mri Devices Corp. NEU Class II 2004-01-28
K032514 AC APPLICATOR, AURORA AC Syneron Medical, Ltd. GEX Class II 2004-01-27
K032667 FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) Focus Medical, LLC GEX Class II 2004-01-23
K040015 MODIFICATION TO PRISMALIX SURGICAL LIGHT Alm S.A. FSY Class II 2004-01-21
K033176 TRISTAR AESTHETIC WORKSTATION LASER Cynosure, Inc. GEX Class II 2004-01-21
K033437 SPHINX LASER SYSTEMS Allmed Systems, Inc. GEX Class II 2004-01-20
K033461 CANDELA VBEAM PULSE DYE LASER SYSTEM Candela Corp. GEX Class II 2004-01-16
K033331 CANDELA CBEAM PULSE DYE LASER SYSTEM Candela Corp. GEX Class II 2004-01-16
K033423 REVOLIX LASER SYSTEMS Allmed Systems, Inc. GEX Class II 2004-01-15
K033310 REMEEX SYSTEM FOR URINARY INCONTINENCE Specialities Remeex International, S.L. OTN Class II 2004-01-15
K033376 UGYTEX MESH Sofradim Production FTL Class II 2004-01-15
K033654 FORCE FIBER Teleflex Medical GAT Class II 2004-01-15
K032245 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 Arthrex, Inc. GAT Class II 2004-01-14
K033547 VNUS VESSEL AND TISSUE COAGULATION SYSTEM Vnus Medical Technologies, Inc. GEI Class II 2004-01-07
K033671 GORE BIOABSORBABLE MESH W. L. Gore & Associates, Inc. OWT Class II 2003-12-31
K031869 SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES Surgical Instruments Service and Savings, Inc. GEI Class II 2003-12-24
K030871 FIDJI LARGE CEMENT RESTRICTOR Spine Next SA JDK Class II 2003-12-22
K030767 FIDJI SMALL CEMENT RESTRICTOR Spine Next SA JDK Class II 2003-12-22
K033799 CLINICAL LASETTE P-200 Cell Robotics, Inc. GEX Class II 2003-12-22
K032944 YA-MAN LASER 21 Ya-Man, Ltd. GEX Class II 2003-12-19
K032893 SHELHIGH NO-REACT BIOCUFF Shelhigh, Inc. FTL Class II 2003-12-19
K033691 SAFYRE VS AND SAFYRE T Promedon OTN Class II 2003-12-19
K032980 AMI REPROCESSED MULTIPLE CLIP APPLIERS Vanguard Medical Concepts, Inc. FZP Class II 2003-12-18
K033746 MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, Inc. GAM Class II 2003-12-18
K033161 VISU-LOCK 5MM CLIP APPLIER Gyrx, LLC FZP Class II 2003-12-18
K032973 REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS Vanguard Medical Concepts, Inc. GDW Class II 2003-12-18
K032942 PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE Wrp Asia Pacific Sdn. Bhd. KGO Class I 2003-12-17
K033602 INSORB ABSORBABLE STAPLE, MODEL SP-B20 Incisive Surgical, Inc. GDW Class II 2003-12-16
K033748 TRIDENT RESECTION ABLATOR Linvatec Corp. GEI Class II 2003-12-15
K032846 SPECTRA PULSED DIODE LASER, MODEL DR-1 Spectragenics, Inc. GEX Class II 2003-12-11
K032205 RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY Radiancy (Israel) , Ltd. GEX Class II 2003-12-11
K033586 MODIFICATION TO AURORA DS Syneron Medical, Ltd. GEX Class II 2003-12-10
K033568 GYNECARE TVT OBTURATOR SYSTEM ETHICON, Inc. OTN Class II 2003-12-08
K032735 SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM Max Engineering , Ltd. GEX Class II 2003-12-03
K030834 CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. GEX Class II 2003-12-03
K032901 STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM Stryker Endoscopy GAT Class II 2003-12-02
K031671 POLARIS WR Syneron Medical, Ltd. GEX Class II 2003-12-01
K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT United States Surgical, A Division of Tyco Healthc GDW Class II 2003-12-01
K033584 ARTHROCARE ARTHROWANDS Arthrocare Corp. GEI Class II 2003-11-28
K033499 MALIS IRRIGATION MODULE 1000 Valley Forge Scientific Corp. GEI Class II 2003-11-28
K032383 MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM Curelight, Ltd. GEX Class II 2003-11-28
K032865 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. FTL Class II 2003-11-28
K032685 CEMSTOP CEMENT RESTRICTOR Teknimed, S.A. LZN Class II 2003-11-26
K014200 OPTIMESH Spineology, Inc. EZX Class II 2003-11-26
K033237 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE Vascular Solutions, Inc. GEX Class II 2003-11-20
K032260 ARAMIS II DERMATOLOGICAL LASER Quantel Medical GEX Class II 2003-11-20
K033057 DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE Deroyal FYA Class II 2003-11-20
K033384 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ Implex Corp. JDK Class II 2003-11-19
K032802 HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III Hk Surgical, Inc. QPB Class II 2003-11-19
K032539 CYNOSURE PHOTOGENICA SV LASER Cynosure, Inc. GEX Class II 2003-11-17
K024206 AURA ISURGICAL LASER SYSTEM & ACCESSORIES Laserscope GEX Class II 2003-11-17
K032160 ARTELON SURGICAL SUTURE Artimplant AB GAR Class II 2003-11-17
K032586 CAPROSYN ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 2003-11-17
K024286 GYRUS OPEN FORCEPS Gyrus Medical, Inc. GEI Class II 2003-11-17
K033115 ORTHODEK Teleflex Medical GAM Class II 2003-11-17
K032744 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2003-11-13
K032460 PROFILE BBL SYSTEM Sciton, Inc GEX Class II 2003-11-13
K031795 RELIANT LASER SYSTEM Reliant Technologies, Inc. GEX Class II 2003-11-10
K032647 ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA Wrp Asia Pacific Sdn. Bhd. KGO Class I 2003-11-07
K033172 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS Candela Corp. GEX Class II 2003-10-30
K033257 ARTHROCARE ENT PLASMA WANDS Arthrocare Corp. GEI Class II 2003-10-30
K031819 DIO-DENT 10 DENTAL DIODE LASER Msq (M2) , Ltd. GEX Class II 2003-10-30
K032599 MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM Medical Laser Technologies, LLC GEX Class II 2003-10-29
K032704 INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 Innovatech Surgical, Inc. GEX Class II 2003-10-24
K032220 ADEPT 1064/532 LASER Adept Medical Concepts GEX Class II 2003-10-24
K033024 MODIFICATION TO SUTURE CLINCH Applied Medical Resources Corp. FZP Class II 2003-10-24
K032221 ADEPT 1064/755 LASER Adept Medical Concepts GEX Class II 2003-10-24
K032703 INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 Innovatech Surgical, Inc. GEX Class II 2003-10-24
K033181 SPR SYSTEM Radiancy (Israel) , Ltd. GEX Class II 2003-10-24
K032218 ADEPT 1064/532/755 LASER Adept Medical Concepts GEX Class II 2003-10-24
K032698 COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE Coapt Systems, Inc. GAM Class II 2003-10-23
K032930 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corp ESW Class II 2003-10-23
K032420 MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, Inc. GAM Class II 2003-10-22

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.