meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
2013-10-16

Clearances · page 46 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K122949 MEDLINE SUCTION COAGULATOR Medline Industries, Inc. GEI Class II 2013-10-16
K130123 BASIC AND DOMINANT FLEX SUCTION PUMPS Medela AG BTA Class II 2013-10-11
K123205 ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. ESW Class II 2013-10-09
K131362 INMODE WMBODY DEVICE Inmode MD , Ltd. NUV Class II 2013-10-08
K130110 MEDDUSA BIPOLAR SYSTEM Elliquence, LLC GEI Class II 2013-10-08
K132224 UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES Unimed Surgical Products, Inc. GEI Class II 2013-10-08
K133017 ESTECH COBRA(R) GENESIS BIPOLAR CLAMP Estech, Inc. GEI Class II 2013-10-07
K131143 TRELLIS COLLAGEN RIBBON Wrightmedicaltechnologyinc OWY Class II 2013-10-07
K132645 THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES Medtronic, Inc. GAD Class I 2013-10-04
K132199 DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST Deroyal Industries, Inc. GEI Class II 2013-10-03
K122557 MOTEX POWDER-FREE NITRILE SURGICAL GLOVES Shanghai Motex Healthcare Co., Ltd. KGO Class I 2013-10-03
K131435 ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, Ethicon Endo-Surgery, LLC GEI Class II 2013-10-03
K132266 SHASER HRS2 RX HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2013-09-30
K132252 EXTRICARE 100CC/ 250CC/ 400CC CANISTERS Devon Medical OMP Class II 2013-09-27
K130983 GENII ARC SMART ARGON PROBE Genii, Inc. GEI Class II 2013-09-26
K132665 PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC Ellman International, Inc. GEI Class II 2013-09-25
K131751 FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES Lucenxia Prescience AG KGO Class I 2013-09-25
K132069 DESARA MESH, DESARA BLUE Caldera Medical, Inc. OTN Class II 2013-09-23
K131903 EQUINOX CO2 LASER Eclipse Aesthetics, LLC ONG Class II 2013-09-19
K121817 VCARE A IVT Medical, Ltd. OMP Class II 2013-09-17
K130760 ELECTROSURGICAL GENERATOR Beijing Jinhengwei Technology Development Co., Ltd. GEI Class II 2013-09-16
K131059 PIONEER ELITE DIODE LASER CAO Group, Inc. GEX Class II 2013-09-13
K112796 SURGICAL GOWN (EO STERILIZED) Cobes Industries Co., Ltd. FYA Class II 2013-09-12
K132431 THERMAGE CPT SYSTEM Solta Medical, Inc. GEI Class II 2013-09-06
K130341 STRAWBERRY, STRAWBERRY & CREAM Laser Lipo Limited OLI Class II 2013-09-06
K132136 SINGLE USE GROUNDING PAD Lccs Products Limited GEI Class II 2013-09-06
K131658 GORE SEAMGUARD REINFORCEMENT W. L. Gore & Associates, Inc. OXC Class II 2013-09-06
K132348 TEPHAFLEX BRAIDED SUTURE Tepha, Inc. NWJ Class II 2013-09-05
K123811 STITCHKIT Origami Surgical, LLC NBY Class II 2013-09-05
K130028 RESURFX 1565NM LASER MODULE Lumenis, Ltd. ONG Class II 2013-09-03
K130165 PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 Advanced Planimetric Services, LLC FXN Class I 2013-08-30
K132374 BAYLIS MEDICAL RF PERFORATION PROBE V2.0 Baylis Medical Company, Inc. GEI Class II 2013-08-30
K131614 REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM Covidien NUJ Class II 2013-08-29
K123999 ILLUMASK ACNE LIGHT THERAPY MASK La Lumiere, LLC OLP Class II 2013-08-28
K121925 POWDERED LATEX SURGEON'S GLOVE Suzhou Colour-Way Enterprise Development Co., Ltd. KGO Class I 2013-08-28
K131949 AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES Encision, Inc. GEI Class II 2013-08-26
K132268 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corporation Dba Angiotech NEW Class II 2013-08-23
K131012 SUTTER BIPOLAR FORCEPS - SUPERGLISS Sutter Medizintechnik GmbH GEI Class II 2013-08-23
K132054 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, Inc. OTN Class II 2013-08-23
K130301 LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) Elimedical Devices (Fujian), Inc. KGO Class I 2013-08-22
K130027 DISPOSABLE NEUTRAL ELECTRODE GP202 Cathay Manufacturing Corp. GEI Class II 2013-08-22
K131969 SYMBOTEX(TM) COMPOSITE MESH Sofradim Production FTL Class II 2013-08-22
K132099 ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND ArthroCare Corporation GEI Class II 2013-08-22
K131523 CRYOBALLOON FOCAL ABLATION SYSTEM C2 Therapeutics GEH Class II 2013-08-22
K130793 NEWA SKIN THERAPY SYSTEM Endymion Medical, Ltd. GEI Class II 2013-08-16
K131870 GLIDE DEVICE Home Skinovations , Ltd. OHT Class II 2013-08-14
K123061 ACE MONOPOLAR ATTACHMENT Bioeconeer, Inc. GEI Class II 2013-08-13
K123443 PRECISE SHP DIODE LASER CAO Group, Inc. GEX Class II 2013-08-13
K131464 EXTRICARE NPWT FOOT DRESSING Devon Medical, Inc. OMP Class II 2013-08-13
K131205 ARTHROCARE HEAD AND NECK COBLATION WAND ArthroCare Corporation GEI Class II 2013-08-09
K123553 ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM Zimmer, Inc. KCY Class I 2013-08-09
K132061 RESTORELLE M, RESTORELLE XL Coloplast Corp. OTO Class II 2013-08-02
K132043 ARTHREX SPEEDCINCH Arthrex, Inc. GAT Class II 2013-07-31
K123908 OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES Matrix Surgical USA KKY Class II 2013-07-31
K131955 NEUROBLATE(TM) SYSTEM Monteris Medical, Inc. GEX Class II 2013-07-30
K130001 CARE SU01A SUCTION ASPIRATOR Foshan Care Medical Technology Co., Ltd. JCX Class II 2013-07-25
K120510 TRANSCEND Syneron Medical, Ltd. GEI Class II 2013-07-19
K130399 CERTUS 140 CERTUSURGGT SURGICAL TOOL Neuwave Medical, Inc. NEY Class II 2013-07-18
K131805 INPULSE LASER Incisive, Inc. GEX Class II 2013-07-18
K123787 GREENCROSS SURGICAL MASK Jingzhou Haixin Green Cross Medical Products Co.,L FXX Class II 2013-07-17
K130083 DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE Demetech Corp. GAM Class II 2013-07-17
K131637 ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) Rotation Medical, Inc. GDW Class II 2013-07-12
DEN110004 CABOCHON SYSTEM Cabochon Aesthetics, Inc. OUP Class II 2013-07-12
K130315 IPULSE HAIR REMOVAL SYSTEM Cyden Limited OHT Class II 2013-07-12
K123366 SURGITRON 4.0 DUAL RF S5-IEC Ellman International, Inc. GEI Class II 2013-07-12
K130420 SOLEA Convergent Dental, Inc. GEX Class II 2013-07-12
K131278 MONTERIS MEDICAL NEUROBLATE SYSTEM Monteris Medical, Inc. GEX Class II 2013-07-11
K130225 QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE Silverbay, LLC, D/B/A Quasar Bio-Tech OHS Class II 2013-07-11
K131007 AIGIS RX N MEDIUM; AIGIS RX N LARGE Tyrx, Inc. FTL Class II 2013-07-10
K130404 TIBURON SURGICAL DRAPE Cardinal Health200, LLC KKX Class II 2013-07-05
K131511 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR Changzhou Sinolinks Medical Innovation Co., Ltd. GDW Class II 2013-07-05
K131081 CYBER TM FAMILY Quanta System Spa GEX Class II 2013-07-03
K122652 ARTHROCARE TURBINATOR WAND ArthroCare Corporation GEI Class II 2013-07-02
K130256 MDK MULTI-APPLICATIONS PLATFORM Quanta System Spa GEX Class II 2013-07-02
K131705 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2013-07-01
K124030 COOK HOLMIUM LASER FIBER Cook Incorporated GEX Class II 2013-07-01
K131654 STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER Senorx, Inc. NEU Class II 2013-06-27
K121481 INFINI RADIOFREQUENCY SYSTEM Lutronic Corporation GEI Class II 2013-06-25
K122567 JOULE 810/940/980 MULTI-PLATFORM SYSTEM Sciton, Inc GEX Class II 2013-06-19
K130193 FRAXEL DUAL 1550/1927 LASER SYSTEM Solta Medical, Inc. GEX Class II 2013-06-14
K130995 NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY Nuance Medical, LLC GEH Class II 2013-06-14
K130015 SHASER V-MINI HAIR REMOVAL SYSTEM Shaser, Inc. ONF Class II 2013-06-13
K130191 MINT Hans Biomed Corporation NEW Class II 2013-06-12
K131303 DISPOSABLE CIRCULAR STAPLER Changzhou City Zhiye Medical Devices Institute Co. GDW Class II 2013-06-11
K121436 DAS MEDICAL EQUIPMENT DRAPES Das Medical, LLC KKX Class II 2013-06-06
K122020 PHOTON PHOTON PLUS Zolar Technology & Mfg Co., Inc. GEX Class II 2013-06-05
K130599 WART FREEZE Koninklijke Utermohlen NV GEH Class II 2013-06-05
K130474 SURGISEAL TOPICAL SKIN ADHESIVE Adhezion Biomedical, LLC MPN Class II 2013-05-31
K130547 ENDOFORM RECONSTRUCTIVE TEMPLATE Mesynthe, Ltd. FTM Class II 2013-05-31
K123034 VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED Unilene Sac GAR Class II 2013-05-28
K123133 BARLE TISSUE ADHESIVE Advanced Medical Solutions (Plymouth), Ltd. MPN Class II 2013-05-22
K130444 H-30 HOLMIUM LASER SYSTEM Cook, Inc. GEX Class II 2013-05-22
K123662 THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM Justright Surgical, LLC GEI Class II 2013-05-22
K122735 SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 Sorin Group USA, Inc. GAT Class II 2013-05-21
K123115 ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P Acme Filter Mask, Inc. FXX Class II 2013-05-20
K130943 AIGIS RX R PM/ AIGIS RX R ICD Tyrx, Inc. FTL Class II 2013-05-20
K121976 AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE Aesculap, Inc. MPN Class II 2013-05-17
K130922 ERCHONIA VERJU LASER SYSTEM WITH MASSAGER Erchonia Medical, Inc. OLI Class II 2013-05-17
K131224 SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE Surgical Specialties Corp. Dba Angiotech GAW Class II 2013-05-16
K122493 GENESISPLUS Cutera, Inc. GEX Class II 2013-05-15

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