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
2012-04-02

Clearances · page 50 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120433 CLEAR + BRILLIANT LASER SYSTEM Solta Medical, Inc. ONG Class II 2012-04-02
K111695 HYBRID GRAFT Cook Biotech, Inc. FTL Class II 2012-04-02
K113233 POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM Shen Wei (Usa), Inc. KGO Class I 2012-03-29
K113702 FOTONA XP ND: YAG LASER SYSTEM Fotona D.D. PDZ Class II 2012-03-28
K120416 INSULATION TESTER Spectrum Surgical Supply Corp. GEI Class II 2012-03-27
K111501 I-LIPO SYSTEM Chromogenex Technologies Limited OLI Class II 2012-03-23
K113265 GENII GI 4000 ELECTROSUGICAL GENERATOR Genii, Inc. GEI Class II 2012-03-22
K113475 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM Endoscopic Technologies, Inc. D/B/A Estech OCL Class II 2012-03-20
K120373 INSORB ABSORBALBE STAPLE Incisive Surgical, Inc. GDW Class II 2012-03-16
K113763 SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE Nobles Medical Technologies Ii, Inc. GAW Class II 2012-03-16
K113090 LEVEEN SUPERSLIM NEEDLE ELECTRODE Boston Scientific Corporation GEI Class II 2012-03-15
K113688 MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM Biolitec Medical Devices, Inc. GEX Class II 2012-03-13
K111523 OSTEOCOOL (TM) RF ABLATION SYSTEM Baylis Medical Co., Inc. GEI Class II 2012-03-13
K113860 VISUAL-ICE CRYOABLATION SYSTEM Galil Medical, Inc. GEH Class II 2012-03-12
K113151 IFS LASER SYSTEM Abbott Medical Optics, Inc. GEX Class II 2012-03-08
K113810 MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES Alma Lasers, Inc. PDZ Class II 2012-03-08
K113255 PUREGRAFT 850/PURE SYSTEM Cytori Therapeutics, Inc. MUU Class II 2012-03-07
K111670 VENUS FREEZE (MP)2 SYSTEM Venus Concept , Ltd. GEI Class II 2012-03-02
K112133 OASYS SURGICAL LIGHT CONTROLLER Oasys Healthcare FTA Class II 2012-03-01
K120258 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2012-02-29
K113202 TISSUE MARKER Focal Therapeutics NEU Class II 2012-02-28
K113545 VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN Depuy Mitek, A Johnson & Johnson Company GEI Class II 2012-02-27
K110375 BLUESHINE'S GOLD SERIES Blueshine Srl PDZ Class II 2012-02-23
K120019 COLLAGEN RIBBON Wrightmedicaltechnologyinc FTM Class II 2012-02-23
K113588 SPECTRA LASER SYSTEM Lutronic Corporation GEX Class II 2012-02-22
K112654 POWDERFREE POLYISOPRENE SURGICAL GLOVES Pt. Medisafe Technologies KGO Class I 2012-02-17
K111689 STLASE Dental Photonics, Inc. GEX Class II 2012-02-16
K120392 CHROMOPHARE F 628 AND F 528 Berchtold GmbH & Co. KG FSY Class II 2012-02-16
K113721 TEPHAFLEX LIGHT MESH Tepha, Inc. OOD Class II 2012-02-15
K113723 TEPHAFLEX MESH Tepha, Inc. OOD Class II 2012-02-15
K113390 LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) Meridian AG GEX Class II 2012-02-14
K113551 ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. ESW Class II 2012-02-14
K113496 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT Coloplast A/S OTM Class II 2012-02-14
K113697 EIGR SURGICAL ILLUMINATION SYSTEM Invuity, Inc. FST Class II 2012-02-10
K120268 AMID STAPLER Safestich Medical, LLC GDW Class II 2012-02-10
K110078 EXTRICARE Devon Medical Products, Inc. OMP Class II 2012-02-10
K111937 CLEARFLASH AC2100 COSMETIC SYSTEM Clearflash Technologies, Inc. OLP Class II 2012-02-08
K113021 TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT CSA Medical, Inc. GEH Class II 2012-02-07
K111959 AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE Aesculap, Inc. MPN Class II 2012-02-06
K113744 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) Angiotech NEW Class II 2012-02-01
K111413 BIOGEL (R) INDICATOR (R) UNDERGLOVE Molnlycke Health Care Us, LLC KGO Class I 2012-01-30
K112600 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2012-01-30
K112233 BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE Bovie Medical Corporation GEI Class II 2012-01-27
K111986 LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM Surgical Innovations Plc GEI Class II 2012-01-26
K102541 CYNOSURE CELLULAZE LASER Cynosure, Inc. OYW Class II 2012-01-26
K111337 TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD Tornier, Inc. FTL Class II 2012-01-25
K113858 MEGABEAM ENDO-ENT PROBE Biolitec Medical Devices, Inc. GEX Class II 2012-01-24
K111202 SURGICAL TISSUE MANAGEMENT SYSTEM Olympus Medical Systems Corp. GEI Class II 2012-01-20
K113800 QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE Angiotech GAW Class II 2012-01-20
K113709 MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE Biolitec Medical Devices, Inc. GEX Class II 2012-01-20
K113792 MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE Biolitec Medical Devices, Inc. GEX Class II 2012-01-19
K111286 QUASAR CALYPSO Silver Bay, LLC OLP Class II 2012-01-18
K112013 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER Biolitec, Inc. GEX Class II 2012-01-13
K113330 CABLECAP Sensormed FST Class II 2012-01-12
K113460 SYNERGY TISSUE MATRIX Synovis Orthopedic & Woundcare FTM Class II 2012-01-11
K110581 PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. FTM Class II 2012-01-10
K112458 PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medica-Rents Co., Ltd. OMP Class II 2012-01-05
K112454 HALO60 ABLATION CATHETER Barrx Medical, Inc. GEI Class II 2012-01-05
K113237 CERTUS 140 2.45GHZ ABLATION SYSTEM Neuwave Medical, Inc. NEY Class II 2012-01-04
K112499 BIOMERIX COMPOSITE SURGICAL MESH Biomerix Corporation FTL Class II 2011-12-23
K112567 BIOMERIX ASSURE Biomerix Corporation FTL Class II 2011-12-23
K112423 COLLAGEN TENDON SHEET Rotation Medical, Inc. FTM Class II 2011-12-22
K113140 VARI-LASE WIREFIBER LASER FIBER Vascular Solutions, Inc. GEX Class II 2011-12-22
K111303 DERMATOLOGICAL TREATMENT DEVICE FAMILY Sharplight Technologies, Ltd. GEX Class II 2011-12-21
K103022 KIM Neomedic International S.L. OTN Class II 2011-12-20
K102921 ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES Bema-GmbH & Co. KG GEI Class II 2011-12-20
K113004 PDS(TM) BARBED SUTURES ETHICON, Inc. NEW Class II 2011-12-20
K103508 UNMIAX LAPAROSCOPIC INSTRUMENT Unimax Medical Systems, Inc. GEI Class II 2011-12-20
K111831 MX-7000 MICROXEL Bio-Med USA, Inc. ONG Class II 2011-12-19
K112056 ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL Ethicon Endo-Surgery, LLC GDW Class II 2011-12-19
K110184 LIQUIBAND FLOW CONTROL Medlogic Global Limited MPN Class II 2011-12-16
K112987 TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM Biolitec Medical Devices, Inc. GEX Class II 2011-12-16
K111170 PICO Smith & Nephew, Inc. OMP Class II 2011-12-15
K113500 CANADY VIEIRA HYBRID PLASMA SCALPEL Us Medical Innovations, LLC GEI Class II 2011-12-09
K111483 JOULE CLEARSENSE LASER SYSTEM Sciton, Inc PDZ Class II 2011-12-07
K110364 DORNIER MEDILAS D LITEBEAM+ 1470 Dornier Medtech America, Inc. GEX Class II 2011-12-07
K110924 DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS Synergetics, Inc. GEI Class II 2011-12-07
K110698 NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE Terang Nusa Sdn Bhd KGO Class I 2011-12-07
K111732 AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER Salient Surgical Technologies, Inc. GEI Class II 2011-12-05
K113032 SNAP WOUND CARE SYSTEM Spiracur, Inc. OKO Class II 2011-12-01
K112782 MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. NRB Class II 2011-12-01
K111458 GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS Gri Medical & Electronic Technology Co., Ltd. KKX Class II 2011-12-01
K103418 DESARA MINI Caldera Medical, Inc. PAH Class II 2011-11-30
K111342 LIGHT GUIDE CABLE Schott North America HBI Class II 2011-11-25
K112784 RENASYS AB ABOMINAL DRESSING KIT Smith & Nephew, Inc. FTL Class II 2011-11-22
K111323 SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS Synthes, Inc. KKY Class II 2011-11-16
K113212 DENTAL LASER THERAPY SYSTEM China Daheng Group, Inc. GEX Class II 2011-11-16
K111026 APOLLO Pollogen, Ltd. GEI Class II 2011-11-16
K111600 REPROCESSED HAND ACTIVATE SEALER/DIVIDER Ascent Healthcare Solutions NUJ Class II 2011-11-15
K111840 EMERGE FRACTIONAL LASER Palomar Medical Products, Inc. ONG Class II 2011-11-14
K102752 STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS Stingray Surgical Products, Inc. GEI Class II 2011-11-09
K111692 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC Somatex Medical Technologies GmbH NEU Class II 2011-11-08
K111930 ACKERMANN EUROPCLIP Ackermann Instrumente GmbH FZP Class II 2011-11-08
K112033 ENSEAL G2 TISSUS SEALERS Ethicon Endo-Sugery, LLC GEI Class II 2011-11-08
K112299 ENDOVASCULAR LASER VEIN SYSTEM KIT Biolitec Medical Devices, Inc. GEX Class II 2011-11-03
K103338 COOLTOUCH New Star Lasers, Inc. PDZ Class II 2011-11-01
K111825 ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2011-10-25
K112786 PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF Synovis Orthopedic and Woundcare, Inc. FTM Class II 2011-10-25
K102329 NANOKNIFE SYSTEM AngioDynamics, Inc. OAB Class II 2011-10-24
K112166 ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE W and R Investments Dba Laser Engineering GEX Class II 2011-10-21

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