meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
44
Latest Decision
2014-07-01

Clearances · page 44 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K140843 DESARA BLUE OV, DESARA BLUE SS Caldera Medical OTN Class II 2014-07-01
K132551 ZF 720 Umbel Corporation FSY Class II 2014-06-30
K140588 FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS Stryker Corporation FXY Class II 2014-06-26
K140629 VENUS SWAN(MP)2 Venus Concept , Ltd. GEI Class II 2014-06-25
K140809 CLIQ DV-300 ASPIRATOR Ding Hwa Co., Ltd. JCX Class II 2014-06-23
K141072 SUPOLENE Resorba Medical GmbH GAT Class II 2014-06-23
K140679 SUREFLEX LITHOTRIPSY LASER FIBERS American Medical Systems GEX Class II 2014-06-20
K140155 SECURE-GARD SURGICAL AND PROCEDURE FACE MASK Cardinal Health200, LLC FXX Class II 2014-06-20
K141356 ECHO TIP ULTRA FIDUCIAL NEEDLE Wilson-Cook Medical, Inc. NEU Class II 2014-06-20
K134032 ULTHERA SYSTEM Ulthera, Inc. OHV Class II 2014-06-20
K133011 DIAPHRAGMATIC HERNIA GRAFT Cook Biotech, Inc. OWV Class II 2014-06-20
K133258 TRUFREEZE SYSTEM CSA Medical, Inc. GEH Class II 2014-06-19
K132833 ULTRA RENEW PLUS Accord Media OLP Class II 2014-06-17
K140006 ENDOSHIELD BURN PROTECTION SYSTEM Encision, Inc. GEI Class II 2014-06-16
K140437 SU-POR SURGICAL IMPLANT Poriferous, LLC KKY Class II 2014-06-13
K140314 WARTIE WART REMOVER Yonmedical BV GEH Class II 2014-06-12
K133770 A.I.M. KNOTLESS MENISCAL REPAIR DEVICE Anchor Innovation Medical (A.I.M.) GAT Class II 2014-06-10
K140967 FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK Insightra Medical FTL Class II 2014-06-10
K140521 TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH ArthroCare Corporation GEI Class II 2014-06-10
K133297 QUADROSTARPROGREEN, QUADROSTARPROYELLOW Asclepion Laser Technologies GmbH GEX Class II 2014-06-10
K140930 VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES Convida Healthcare & Systems Corporation FSY Class II 2014-06-09
K140539 AERO BLUE PERFORMANCE SURGICAL GOWN Kimberly-Clark Corporation FYA Class II 2014-06-09
K133774 ATOVEN Bio-Med USA, Inc. GEX Class II 2014-06-06
K140422 HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM Het Systems, LLC GEI Class II 2014-06-05
K123126 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) Shanghai Motex Healthcare Co., Ltd. KGO Class I 2014-06-04
K123940 DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE Demetech Corp. GAM Class II 2014-05-30
K131712 A-TONE IPL SYSTEM Ybk Investment, Inc. ONF Class II 2014-05-30
K133198 ULTRAPRO COMFORT PLUG ETHICON, Inc. FTL Class II 2014-05-30
K140127 FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP Pontis Orthopaedics, LLC GAQ Class II 2014-05-28
K132838 NUTRA LIGHT BLUE Nutra Luxe MD, LLC OLP Class II 2014-05-23
K140384 FMWAND HANDPIECE SE Domain Surgical, Inc. GEI Class II 2014-05-23
K133405 MINNIE Elettronica Valseriana Srl GEI Class II 2014-05-23
K132802 MOTEX POWDERED NITRILE SURGICAL GLOVES Shanghai Motex Healthcare Co., Ltd. KGO Class I 2014-05-21
K140533 GALAFLEX MESH Tepha, Inc. OOD Class II 2014-05-21
K140835 GENERAL AND PLASTIC SURGERY Scion Medical Technologies, LLC NEU Class II 2014-05-20
K132703 THUNDERBEAT Olympus Medical Systems Corp. GEI Class II 2014-05-19
K131096 AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM Arobella Medical, LLC NRB Class II 2014-05-16
K140631 LUMENA FH HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2014-05-16
K132225 EXTRICARE Devon Medical, Inc. OMP Class II 2014-05-15
K133046 OMNIPORE CUSTOMIZED SURGICAL IMPLANTS Matrix Surgical Holdings, LLC/Matrix Surgical USA KKY Class II 2014-05-14
K140255 STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) Pollogen, Ltd. GEI Class II 2014-05-14
K140343 AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP Aesculap, Inc. MPN Class II 2014-05-13
K133718 ZERONA Erchonia Corporation OLI Class II 2014-05-12
K140122 CANDELA GENTLEMAX FAMILY OF LASER SYSTEM Candela Corp. GEX Class II 2014-05-09
K140941 PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH Sofradim Production FTL Class II 2014-05-07
K132004 NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE Creo Quality, LLC OMP Class II 2014-05-02
K140517 SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2014-04-28
K140501 XENMATRIX SURGICAL GRAFT C. R. Bard FTM Class II 2014-04-28
K140839 CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. GEI Class II 2014-04-28
K133821 EMPRINT ABLATION SYSTEM Covidien, LLC NEY Class II 2014-04-28
K140031 SUCTION PUMP Ding Hwa Co., Ltd. JCX Class II 2014-04-28
K140179 EASY GO VAC Precision Medical, Inc. BTA Class II 2014-04-25
K131838 DIODE LASER FOR HIAR REMOVAL Beijing Honkon Technologies Co., Ltd. GEX Class II 2014-04-24
K140560 ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING Ethicon Endo-Surgery, LLC GDW Class II 2014-04-22
K133915 GALAXY CO2 LASER SYSTEM Beijing Toplaser Technology Co., Ltd. GEX Class II 2014-04-18
K140495 LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE Boston Scientific Corp GEI Class II 2014-04-17
K133006 NEOV DIODE LASER FAMILY G.N.S Neolaser , Ltd. GEX Class II 2014-04-17
K132976 ADVATX Advalight Aps GEX Class II 2014-04-17
K140503 FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER Boston Scientific GEX Class II 2014-04-15
K130852 AVANCE® FOAM ABDOMINAL DRESSING KIT Molnlycke Health Care OXJ Class II 2014-04-14
K134010 CABOCHON SYSTEM Cabochon Aesthetics, Inc. OUP Class II 2014-04-14
K133238 CONTOUR I V3.1 SYSTEM Syneron Medical, Ltd. OHV Class II 2014-04-10
K133578 REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER Stryker Sustainability Solutions NUJ Class II 2014-04-10
K131563 SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM Opus Ksd, Inc. GDW Class II 2014-04-09
K140609 RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS Covidien GDW Class II 2014-04-09
K133212 ZELTIQ COOLSCULPTING SYSTEM Zeltiq Aesthetics, Inc. OOK Class II 2014-04-09
K133837 VIORA V-TOTAL Viora , Ltd. GEX Class II 2014-04-09
K133554 SURGICAL LIGHT HANDLE COVER Microtek Medical, Inc. an Ecolab Company FTA Class II 2014-04-08
DEN130016 XSTAT Revmedx, Inc. PGZ Class II 2014-04-03
K140460 MACH LED 2SC Dr. Mach GmbH & Co. KG FSY Class II 2014-04-03
K140461 MACH LED 2MC Dr. Mach GmbH & Co. KG FSY Class II 2014-04-03
K140584 ICEROD CX CRYOABLATION NEEDLE Galil Medical , Ltd. GEH Class II 2014-03-31
K134033 MIROMATRIX BIOLOGICAL MESH Miromatrix Medical, Inc. FTM Class II 2014-03-31
K140300 COLLAGEN TENDON SHEET-DDI (CTS-DDI) Rotation Medical, Inc. OWY Class II 2014-03-26
K140415 MONOTEX Riverpoint Medical NBY Class II 2014-03-26
K133232 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2014-03-24
K133786 DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID Dornoch Medical Systems, Inc. JCX Class II 2014-03-21
K132607 NS 2500 HOLMIUM LASER SYSTEM New Star Lasers, Inc. GEX Class II 2014-03-21
K133319 ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 Lumenis, Ltd. GEX Class II 2014-03-20
K132975 SPHINX JR Allmed Systems, Inc. GEX Class II 2014-03-18
K134054 BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR Bovie Medical Corporation GEI Class II 2014-03-17
K132698 FASTOUCH FIXATION SYSTEM Via Surgical , Ltd. GDW Class II 2014-03-14
K140388 LUMENIS PULSE 120H Lumenis, Ltd. GEX Class II 2014-03-14
K130501 INTENSIF Endymed Medical, Ltd. OUH Class II 2014-03-13
K132080 SNAP WOUND CARE SYSTEM Spiracur, Inc. OKO Class II 2014-03-12
K140064 SURGISLEEVE WOUND PROTECTOR Covidien KKX Class II 2014-03-12
K122358 NOVEON Hogan Lovells US LLP GEX Class II 2014-03-11
K121664 T4/T5 HYTREL TOGAS Stryker Corporation FYA Class II 2014-03-10
K133196 IMPACT MODEL 323 ASPIRATOR Impact Instrumentation, Inc. JCX Class II 2014-03-10
K133864 DERMABOND PRINEO SKIN CLOSURE SYSTEM ETHICON, Inc. OMD Class II 2014-03-10
K133254 REVLITE Q-SWITCHED ND:YAG LASER SYSTEM Cynosure, Inc. GEX Class II 2014-03-05
K132936 NOVOPORE DRESSING Polynovo Biomaterials Pty, Ltd. OMP Class II 2014-03-04
K131659 MOERAE VEIN PREPARATION KIT Moerae Matrix, Inc. GBX Class I 2014-03-03
K131402 VISICLEAR SMOKE EVACUATION SYSTEM Buffalo Filter Co., Inc. FYD Class II 2014-03-03
K132580 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, Inc. GAM Class II 2014-02-28
K133158 ND: YAG LASER SYSTEM Beijing Toplaser Technology Co., Ltd. GEX Class II 2014-02-28
K140227 MONODERM SURGICAL SUTURE Surgical Specialties Corp GAM Class II 2014-02-28
K140118 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE Cardica, Inc. GDW Class II 2014-02-25
K133137 CISNAP CLOSED INCISION SYSTEM Spiracur, Inc. OKO Class II 2014-02-25
K132949 PELLEFIRM Ellman International, Inc. PBX Class II 2014-02-20

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