meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
36
Latest Decision
2014-10-15

Clearances · page 43 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K134009 UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL Medtek Lighting FTC Class II 2014-10-15
K141776 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, Inc. NEW Class II 2014-10-15
K131987 MULTIPULSE HOPLUS Asclepion Laser Technologies GmbH GEX Class II 2014-10-15
K142614 AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc. GEX Class II 2014-10-10
K140120 EPIC 10 Biolase, Inc. GEX Class II 2014-10-10
K142198 BNX Fine Needle Aspiration System Covidien, LLC NEU Class II 2014-10-08
K140249 LONG PULSE ND: YAG LASER SYSTEM Advanced Technology Laser Co., Ltd. GEX Class II 2014-10-08
K142538 LiNA SafeAir Smoke Pencil Lina Medical Aps GEI Class II 2014-10-06
K141708 ULTRASHAPE SYSTEM Syneron Medical, Ltd. OHV Class II 2014-10-06
K141973 DIODE LASER HAIR REMOVAL SYSTEM Beijing Anchorfree Technology Co., Ltd. GEX Class II 2014-10-06
K142364 Barrx RFA Self Sizing Balloon Catheter Covidien, LLC GEI Class II 2014-10-01
K130450 SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE Purna Bina Sdn Bhd KGO Class I 2014-09-30
K142076 CLAVEGUARD FREEDOM SURGICAL LIGHT Dickson & Dickson Healthcare (Us), Inc. FSY Class II 2014-09-30
K142386 Operating Room Light Handle Adapter Litex Manufacturing, Inc. FTA Class II 2014-09-29
K141097 CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE Touchstone International Medical Science Co., Ltd. GDW Class II 2014-09-26
K141007 DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE Demetech Corp. GAQ Class II 2014-09-25
K140378 FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT Omniguide, Inc. GEX Class II 2014-09-25
K140670 ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ Ellipse A/S ONF Class II 2014-09-25
K140837 LUCID LY Bio-Med USA, Inc. GEX Class II 2014-09-24
K141591 SMARTGRAFT 30 SYSTEM Ingeneron, Inc. MUU Class II 2014-09-24
K142376 Palomar Icon Aesthetic System Cynosure, Inc. GEX Class II 2014-09-24
K140719 PICOSURE WORKSTATION Cynosure, Inc. GEX Class II 2014-09-22
K141255 SIMEX SUBGLOTTIC ASPIRATION SYSTEM Simex Medizintechnik GmbH BTA Class II 2014-09-22
K141437 XLR8 PLUS (XLR8+) Genadyne Biotechnologies, Inc. OMP Class II 2014-09-19
K133223 XENMATRIX AB SURGICAL GRAFT C.R. Bard, Inc. PIJ Class II 2014-09-19
K140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit Devon Medical, Inc. OMP Class II 2014-09-19
K142309 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. MVR Class II 2014-09-16
K141122 HARMONIC SCALLOP BLADE, GENERATOR G11 Ethicon Endo-Surgery, LLC GEI Class II 2014-09-15
K140039 POLYCRYL Aurolab GAM Class II 2014-09-15
K142225 Pilot Elite Diode Laser CAO Group, Inc. GEX Class II 2014-09-12
K142223 Pilot Pro Diode Laser CAO Group, Inc. GEX Class II 2014-09-12
K141033 SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV Argentum Medical, LLC OMP Class II 2014-09-12
K142226 Pilot Ultra Diode Laser CAO Group, Inc. GEX Class II 2014-09-12
K142241 LARIAT sulture Delivery Device Sentreheart, Inc. GAT Class II 2014-09-12
K141425 ELITE + LASER SYSTEM Cynosure, Inc. GEX Class II 2014-09-11
K140195 SURGICAL DRAPE Griffith-Lucas, LLC KKX Class II 2014-09-10
K134040 BTL-9000; BTL-9000 RADIOFREQUENCY MODULE Btl Industries, Ltd. OLI Class II 2014-09-10
K133963 SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2014-09-09
K133895 DEKA SMARTXIDE LASER SYSTEM El.En S.P.A. GEX Class II 2014-09-05
K133739 TRUSCULPT Cutera, Inc. PBX Class II 2014-09-05
K140964 CALCULASE II KARL STORZ Endoscopy-America, Inc. GEX Class II 2014-09-04
K133889 PREMIUM Cousin Biotech Sas FTL Class II 2014-09-04
K141719 BIOGEL PL MICRO SURGICAL GLOVE Molnlycke Health Care Us, LLC KGO Class I 2014-09-04
K140009 SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM Alma Lasers , Ltd. GEX Class II 2014-08-29
K142166 TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES Zimmer, Inc. FYA Class II 2014-08-28
K142120 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP AtriCure, Inc. FZP Class II 2014-08-28
K141318 CIANNA MEDICAL SGS SYSTEM Cianna Medical, Inc. PDW Class II 2014-08-27
K141095 STRYKER STERI-SHIELD FLYTE HYBRID TOGAS Stryker Corporation FYA Class II 2014-08-26
K140458 DIOTECH LASER FIBER Diotech CO GEX Class II 2014-08-26
K141553 MEDELA THOPAZ+ Medela AG BTA Class II 2014-08-25
K141288 VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE Applied Medical Resources GEI Class II 2014-08-22
K141215 SURGISEAL TWIST TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2014-08-21
K141357 BARRX FLEX RFA ENERGY GENERATOR Covidien Iic GEI Class II 2014-08-21
K141308 NUTRA LIGHT RED Nutra Luxe MD, LLC OHS Class II 2014-08-20
K140330 3M STERI-DRAPE FABRIC SURGICAL DRAPES 3M Healthcare KKX Class II 2014-08-18
K132518 NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE Wellquest Intl., Inc. OHT Class II 2014-08-17
K140306 CORMATRIX PROTECT ECM ENVELOPE Cormatrix Cardiovascular, Inc. FTM Class II 2014-08-15
K140366 ENDLESSFIBER REUSABLE SURGICAL LASER FIBER Hogue Surgical, LLC GEX Class II 2014-08-15
K141438 WHITNEY MEDICAL SOLUTIONS ESHIELD Whitney Medical Solutions KKX Class II 2014-08-14
K141153 LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED Covidien GEI Class II 2014-08-14
K140782 ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR Celleration, Inc. NRB Class II 2014-08-13
K140988 POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) Hebei Hongsen Plastics Technology Co, Ltd. KGO Class I 2014-08-12
K141225 ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD Olympus Winter & Ibe GmbH GEI Class II 2014-08-12
K141983 NEUROBLATE SYSTEM Monteris Medical Corp. GEX Class II 2014-08-11
K133945 CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. GEX Class II 2014-08-11
K141101 LITHO Quanta System Spa GEX Class II 2014-08-08
K140381 SENSILIGHT/ SENSILIGHT PLUS El Global Trade, Ltd. OHT Class II 2014-08-08
K140812 MI-750 PROCEDURAL/MINOR SURGICAL LIGHT Medical Illumination International, Inc. FSY Class II 2014-08-07
K141403 LITHO DK30 Quanta System Spa GEX Class II 2014-08-07
K141394 X-REPAIR Synthasome FTL Class II 2014-08-06
K133546 STARLITE-OM, LIGHT EFFECTS, THIBIANT Ps Advanced Engineering OHS Class II 2014-08-06
K140896 VAPR ARCTIC SUCTION ELECTRODE Depuy Mitek, A Johnson & Johnson Company GEI Class II 2014-08-05
K141858 CLOSURERFG RADIOFREQUENCY GENERATOR Covidien GEI Class II 2014-08-05
K140603 ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM Saphena Medical, Inc. GEI Class II 2014-07-31
K140527 SENSILIGHT MINI El Global Trade, Ltd. OHT Class II 2014-07-31
K132353 SUCTION LIPOPLASTY ACCESSORIES Inex QPB Class II 2014-07-30
K132797 L'DISQ U&I Corporation GEI Class II 2014-07-30
K141778 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corporation GAM Class II 2014-07-30
K141484 OPEN FMSEALER Domain Surgical, Inc. GEI Class II 2014-07-30
K140500 SKINTACT Leonhard Lang GmbH GEI Class II 2014-07-29
K133809 OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE Oxford Performance Materials KKY Class II 2014-07-28
K140250 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE 3M Healthcare KKX Class II 2014-07-25
K141367 LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS Touchstone International Medical Science Co., Ltd. GDW Class II 2014-07-25
K141838 SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) Regulatory Technology Services, LLC GEX Class II 2014-07-25
K133306 SIS HERNIA GRAFT Cook Biotech, Inc. FTM Class II 2014-07-23
K140578 ARTHROSCOPIC ENERGY SYSTEM Conmed Corporation GEI Class II 2014-07-23
K141583 SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY Shaser, Inc. ONF Class II 2014-07-22
K133364 PICOSURE WORKSTATION Cynosure, Inc. GEX Class II 2014-07-22
K141625 POLYSYN SURGICAL SUTURE Surgical Specialties Corp GAM Class II 2014-07-18
K140005 ALMA DIODE TABLETOP LASER Alma Lasers , Ltd. GEX Class II 2014-07-18
K131757 TATTOOSTAR EFFECT COMBO Asclepion Laser Technologies GmbH GEX Class II 2014-07-17
K133890 AESCULAP OPTILENE NONABSORBABLE SUTURE Aesculap, Inc. GAW Class II 2014-07-15
K141063 LINSCAN 808, LINSCAN 980 Gme (German Medical Engineering) GmbH GEX Class II 2014-07-15
K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE Surgical Specialties Corp GAM Class II 2014-07-11
K140459 ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM Conmed Corporation GEI Class II 2014-07-11
K132806 FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE Fotona D.D. GEX Class II 2014-07-11
K141027 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP Implantech Associates, Inc. FWP Class II 2014-07-10
K140658 THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES Conmed Corporation GEI Class II 2014-07-10
K141499 X-REPAIRSL Synthasome, Inc. FTL Class II 2014-07-02
K141485 ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE Galil Medical , Ltd. GEH Class II 2014-07-02

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