meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
40
Latest Decision
2009-11-12

Clearances · page 56 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K093402 AUTOSUTURE EEA ORVIL Surgical Devices, A Global Business Unit Tyco GDW Class II 2009-11-12
K093408 V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE Surgical Devices, A Division of Tyco Healthcare GAM Class II 2009-11-12
K093169 SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) A Plus International, Inc. FYA Class II 2009-11-12
K093410 AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY Surgical Devices, A Divsion of Tyco Healthcare GDW Class II 2009-11-12
K090739 BARD SACROCOLPOPEXY GRAFT C.R. Bard, Inc. OTO Class II 2009-11-10
K092487 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A Barrx Medical, Incorporated GEI Class II 2009-11-10
K092735 GREENLIGHT XPS LASER SYSTEM American Medical Systems, Inc. GEX Class II 2009-11-09
K092009 MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 Boston Scientific Corporation GEI Class II 2009-11-06
K091568 LH-75 PHOTOTHERAPY SYSTEM Lerner Medical Devices, Inc. FTC Class II 2009-11-05
K093296 ALEXIS LAPAROSCOPIC SYSTEM Applied Medical Resources Corp. KGW Class II 2009-11-05
K091625 EPICARE-DUO LASER SYSTEM Light Age, Inc. GEX Class II 2009-11-03
K093300 ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES Cardinal Health, Inc. KGO Class I 2009-10-30
K091115 ECO2 LASER SYSTEM Lutronic Corporation GEX Class II 2009-10-30
K091290 ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 Ethicon Endo-Surgery, Inc. GEI Class II 2009-10-29
K093251 OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM Omniguide, Inc. GEX Class II 2009-10-29
K090639 EXELO2, MODEL 4010 Quantel Derma GmbH ONG Class II 2009-10-29
K082584 GIVEN ELECTROSURGICAL NEEDLE Tripps Court Enterprises, Inc. GEI Class II 2009-10-28
K091446 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE Palomar Medical Products, Inc. ONG Class II 2009-10-27
K091499 MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) Kensey Nash Corp. FTM Class II 2009-10-22
K092824 N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 Alpha Protech, Inc. MSH Class II 2009-10-21
K092879 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER Valleylab GEI Class II 2009-10-16
K091420 FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 Solta Medical, Inc. ONG Class II 2009-10-14
K092212 BUSSE SURGICAL DRAPES III Busse Hospital Disposables, Inc. KKX Class II 2009-10-09
K091574 SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES Supplidores Unidos Internacionales, S.A. GAT Class II 2009-10-09
K091440 LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L Bovie Medical GEI Class II 2009-10-09
K090724 OR-LIGHT Yperion Technology ONF Class II 2009-10-07
K093018 G-PROX ENDOSCOPIC GRASPER, MODEL 205333 Usgi Medical GAT Class II 2009-10-07
K092197 PHOTEX30 DIODE LASER SERIES: 980, 810, 940 Biotex, Inc. GEX Class II 2009-10-06
K091721 CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 New Medical Technologies GmbH GEH Class II 2009-10-02
K092195 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) Cutera, Inc. NUV Class II 2009-10-01
K083927 WATERLASE MD Biolase Technology, Inc. GEX Class II 2009-10-01
K083157 HS AMICA H.S Hospital Service S.P.A NEY Class II 2009-09-29
K091228 SPINEWAND SURGICAL DEVICE Arthrocare Corp. GEI Class II 2009-09-28
K091246 ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) Trumpf Medizin Systeme GmbH + Co. KG FSS Class II 2009-09-28
K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 Primed Medical Products, Inc. FXX Class II 2009-09-25
K091800 LIPOEZE LASER ASSISTED ASPIRATION CANNULA Curve Medical GEX Class II 2009-09-23
K091060 VESOCCLUDE LIGATING CLIP Vesocclude Medical, LLC FZP Class II 2009-09-23
K091343 MRI NEURO DRAPE Surgivision, Inc. KKX Class II 2009-09-22
K092304 ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES Cardinal Health, Inc. KGO Class I 2009-09-15
K092533 FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES Beere Precision Medical Instruments, Kmedic, Telef GAT Class II 2009-09-15
K092577 ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) Ethicon Endo-Surgery, LLC GDW Class II 2009-09-15
K091223 VALLEYLAB SUCTION COAGULATOR, MODEL E3305 Covidien LP GEI Class II 2009-09-11
DEN080006 ULTHERA SYSTEM, MODEL 8850-0001 Ulthera, Inc. OHV Class II 2009-09-11
K091562 DOCTOR SMILE A-810 AND B-980 LASERS Lambda Scientific Spa GEX Class II 2009-09-08
K091537 CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH Cynosure, Inc. GEX Class II 2009-09-03
K082391 PRIMAEVA MEDICAL RENESIS SYSTEM Primaeva Medical, Inc. GEI Class II 2009-09-01
K092284 LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 Medical Device Resource Corp. MUU Class II 2009-09-01
K091142 TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 Rti Biologics, Inc. FTM Class II 2009-08-31
K090309 LAGIS ENDOSCOPIC INSTRUMENTS Lagis Enterprises Co, Ltd. GEI Class II 2009-08-28
K090762 LEDA Quantel Derma GmbH GEX Class II 2009-08-28
K091733 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 Maquet Cardiovascular, LLC GEI Class II 2009-08-28
K082040 MINISILK FT El.En Electronic Engineering Spa ONF Class II 2009-08-27
K083608 ERBE HYBRID KNIFE Erbe USA, Inc. GEI Class II 2009-08-26
K090258 VENTURI NPWT V. II ADVANCED VACUUM SYSTEM Talley Medical OMP Class II 2009-08-25
K090581 TANTALUM BEAD SET, MODEL P003175 Halifax Biomedical, Inc. NEU Class II 2009-08-21
K091320 SPECTRA SP II, SPECTRA DENTA II Lutronic Corporation GEX Class II 2009-08-19
K091074 AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES Encision, Inc. GEI Class II 2009-08-17
K091059 FOXQ 980 LASER A.R.C Laser GmbH GEX Class II 2009-08-13
K063461 ANOVA CONTAINMENT DEVICE Anova Corporation EZX Class II 2009-08-13
K090571 ALMA LASERS ALEX755 MODULE Alma Lasers , Ltd. GEX Class II 2009-08-13
K080844 G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE Gyrus Acmi, Inc. GEI Class II 2009-08-13
K092203 OMNISURE URETHRAL SLING, MODEL OTK52 Mpathy Medical Devices, Ltd. OTN Class II 2009-08-12
K090681 TANSCU O2 Electrochemical Oxygen Concepts, Inc. KPJ Class II 2009-08-12
K091357 MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 Kimberly-Clark Corp. FYA Class II 2009-08-10
K090978 UC-CARE WARMING SYSTEM UC-CARE , Ltd. GEH Class II 2009-08-10
K091633 TEPHAFLEX SURGICAL FILM Tepha, Inc. OOD Class II 2009-08-07
DEN080011 SNAP WOUND CARE DEVICE Spiracur, Inc. OKO Class II 2009-08-07
K090586 BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) Bovie Medical GEI Class II 2009-08-07
K091659 BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 C.R. Bard, Inc. FTL Class II 2009-08-03
K091178 MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN Mtp Medical Technical Promotion GmbH MMP Class II 2009-07-31
K091796 SOFTLASE PRO, ORTHOLASE AND HYGIENELASE Zap Lasers, LLC GEX Class II 2009-07-31
K083461 IMAGINE TC SKIN THERAPY SYSTEM Endymion Medical, Ltd. GEI Class II 2009-07-24
K083354 FLORASEAL, MODEL FS350D Adhezion Biomedical NZP Class II 2009-07-20
K091900 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE Covidien Lp, Formerly Registered AS United States GDW Class II 2009-07-16
K091666 PASCAL PHOTOCOAGULATOR, PASCAL-US Optimedica Corporation GEX Class II 2009-07-15
K091180 MINITAPE URETHRAL SLING Mpathy Medical Devices, Ltd. PAH Class II 2009-07-14
K091922 WATERLASE C100, MODEL 7100104 Biolase Technology, Inc. GEX Class II 2009-07-14
K090688 COOK UROLOGICAL GRAFT Cook Biotech, Inc. PAG Class II 2009-07-10
K091470 RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 Smith & Nephew, Inc. OMP Class II 2009-07-09
K091909 LITHO LASER SYSTEM Quanta System Spa GEX Class II 2009-07-09
K090221 REACTION SYSTEM Viora , Ltd. NUV Class II 2009-07-01
K091816 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation ESW Class II 2009-07-01
K081923 ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD Glaxosmithkline Consumer Healthcare ONT Class II 2009-07-01
K090126 FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, Fotona D.D. GEX Class II 2009-06-29
K090580 THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES Solta Medical, Inc. GEI Class II 2009-06-26
K091510 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 Boston Scientific Corporation ESW Class II 2009-06-26
K090164 CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER Biolitec, Inc. GEX Class II 2009-06-26
K083895 CODMAN ISOCOOL BIPOLAR FORCEPS Codman & Shurtleff, Inc. GEI Class II 2009-06-23
K090393 ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 Arthrocare Corp. GEI Class II 2009-06-23
K091551 VARI-LASE PLATINUM BRIGHT TIP LASER FIBER Vascular Solutions, Inc. GEX Class II 2009-06-19
K090962 CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM Quanta System Spa GEX Class II 2009-06-19
K091038 AS 1000 ULTRASOUND WOUND THERAPY SYSTEM Arobella Medical, LLC NRB Class II 2009-06-19
K090306 ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT Aragon Surgical, Inc. GEI Class II 2009-06-18
K090837 STRATAPULSE TS AND STRATAPULSE Advanced Medical Photonics ONF Class II 2009-06-17
K090721 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 Medtronic OCL Class II 2009-06-16
K082505 KLS MARTIN ELECTROSURGICAL INSTRUMENTS Kl Martin L.P. GEI Class II 2009-06-12
K083352 VEINWAVE, TC3000 Newlands Clinical Trials, Ltd. ONQ Class II 2009-06-12
K083616 PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS Patholase, Inc. GEX Class II 2009-06-12
K091432 XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 Anulex Technologies, Inc. GAT Class II 2009-06-12
K090821 CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L Frankenman International Limited GDW Class II 2009-06-10

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