meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
39
Latest Decision
2004-11-12

Clearances · page 71 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042216 COOL-TIP RF ABLATION SYSTEM Valleylab GEI Class II 2004-11-12
K042909 STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A Stellartech Research Corp. GEI Class II 2004-11-12
K041855 PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S Aearo Co. MSH Class II 2004-11-10
K042555 SURGICHIP TAG SURGICAL MARKER Surgichip, Inc. FZZ Class I 2004-11-09
K042949 PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) C.R. Bard, Inc. PAG Class II 2004-11-09
K042851 MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT Mentor Corp. OTN Class II 2004-11-09
K042211 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS Surgical Laser Technologies, Inc. GEX Class II 2004-11-08
K041959 POLARIS DS/COMET Syneron Medical, Ltd. GEX Class II 2004-11-08
K042811 VIVOSORB SHEET, MODEL FS01 Polyganics B.V., FTL Class II 2004-11-08
K041968 GENICON BIPOLAR FORCEPS MODEL # 600-005-005 Genicon GEI Class II 2004-11-03
K042809 CUFFPATCH Organogenesis, Inc. FTM Class II 2004-11-02
K042496 ADEPT ULTRALITE 532 LASER Adept Medical Concepts GEX Class II 2004-11-02
K042134 VERSATILE 1 WOUND VACUUM SYSTEM Blue Sky Medical Group Incorporated OMP Class II 2004-11-01
K041669 VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD Synovis Surgical Innovations FTM Class II 2004-10-27
K042077 BITECH BIPOLAR SCISSORS Guenter Bissinger Medizintechnik GmbH GEI Class II 2004-10-27
K042034 NUVASIVE MAXCESS LIGHT GUIDE Nuvasive, Inc. FST Class II 2004-10-26
K042075 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE Quill Medical, Inc. NEW Class II 2004-10-26
K042604 VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS Valley Forge Scientific Corp. GEI Class II 2004-10-22
K041633 GYRUS PLASMACISION LAPAROSCOPIC SPATULA Gyrus Medical, Inc. GEI Class II 2004-10-22
K042492 HAND STC, MODEL 60MM Niti Medical Technologies , Ltd. GDW Class II 2004-10-19
K041969 AURORA DS Syneron Medical, Ltd. GEX Class II 2004-10-19
K042031 OPUS SPEEDSTITCH SUTURE DEVICE Opus Medical, Inc. GAT Class II 2004-10-19
K040485 MAXAIR SURGICAL HELMET SYSTEM Bio-Medical Devices, Inc. FYA Class II 2004-10-18
K042608 TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 Tecno Instruments (Pvt.) , Ltd. GEI Class II 2004-10-18
K042667 SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) Galil Medical , Ltd. GEH Class II 2004-10-14
K042502 3 SERIES PHOTOTHERAPY CABINET Daavlin Distributing Co. FTC Class II 2004-10-14
K033421 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS Erbe USA, Inc. GEI Class II 2004-10-14
K042367 NYLON THREADED NEEDLE Aros Surgical Instruments Corp. GAR Class II 2004-10-14
K041943 XTRAC XL, MODEL AL8000 Photo Medex, Inc. GEX Class II 2004-10-14
K040563 LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) Sandstone Medical Technologies, LLC GEX Class II 2004-10-08
K042439 AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM Diamond Age Systems, Inc. GEX Class II 2004-10-07
K041994 MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM Curelight, Ltd. GEX Class II 2004-10-06
K042137 PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS Promedical Products Co., Ltd. KKX Class II 2004-10-05
K042065 WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM Boston Scientific Corp MQR Class II 2004-09-30
K042267 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP Inovel, LLC MSH Class II 2004-09-30
K041767 COOLCUBE COOLPEN Bruce J. Sand M.D. GEX Class II 2004-09-30
K041739 EDWARDS E360 SURGICAL ABLATION DEVICE Edwards Lifesciences, LLC GEX Class II 2004-09-29
K042474 ARION Wavelight Laser Technologie AG GEX Class II 2004-09-29
K042233 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE Depuy Mitek, A Johnson & Johnson Company GAM Class II 2004-09-28
K040921 COOLTOUCH, MODEL NS 160 Cooltouch, Inc. GEX Class II 2004-09-28
K041783 POLAR WAND Chek-Med Systems GEH Class II 2004-09-28
K041868 VALUPEN,PROFILE Conmed Corporation GEI Class II 2004-09-28
K042141 POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE Teleflex Medical GAM Class II 2004-09-28
K041587 LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 Valleylab GEI Class II 2004-09-28
K041890 CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 Cryocor, Inc. OCL Class II 2004-09-22
K041593 FEATHERLIFT EXTENDED LENGTH APTOS THREAD Surgical Specialties Corp GAW Class II 2004-09-20
K042261 MACROPORE PURICEL LIPOPLASTY SYSTEM Macropore Biosurgery, Inc. QPB Class II 2004-09-20
K042341 ULTRACLIP II US Inrad NEU Class II 2004-09-20
K042296 BIOMARC PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. NEU Class II 2004-09-20
K041894 ORTHOFIBER Cp Medical GAT Class II 2004-09-17
K041437 MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE Terang Nusa Sdn Bhd KGO Class I 2004-09-16
K041751 COMPRESSION ANASTOMOSIS CLIP (CAC) Niti Medical Technologies , Ltd. FZP Class II 2004-09-16
K041269 ATRIUM MEDICAL CORPORATION ICAST COVERED STENT Atrium Medical Corp. JCT Class II 2004-09-14
K032991 LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX Light Age, Inc. GEX Class II 2004-09-14
K041621 LITEPORT LP100 SURGICAL ILLUMINATOR Medical Vision Industries, Inc. FTF Class II 2004-09-13
K042026 BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 C.R. Bard, Inc. FTL Class II 2004-09-10
K041285 GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) Gyrus Medical , Ltd. GEI Class II 2004-09-10
K041930 VARILITE LASER SYSTEM Iridex Corporation GEX Class II 2004-09-10
K042139 VISULAS YAG III Carl Zeiss Meditec, AG GEX Class II 2004-09-09
K041923 BIOBLANKET Kensey Nash Corp. FTM Class II 2004-09-08
K041660 TRIMEDYNE HOLMIUM LASER SYSTEMS Trimedyne, Inc. GEX Class II 2004-09-08
K041829 FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS Focus Medical, LLC GEX Class II 2004-09-07
K042170 EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 Neothermia Corporation GEI Class II 2004-09-07
K041405 ASPIRATION PUMP, MODEL IMD-020 Industrial & Medical Design, Inc. BTA Class II 2004-09-02
K041333 SYNTHES (USA) TITANIUM WIRE Synthes (Usa) GAQ Class II 2004-08-27
K041419 LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM Medical Energy, Inc. GEX Class II 2004-08-26
K041846 SABRESOURCE DRAPE Minrad, Inc. KKX Class II 2004-08-26
K041711 ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 Applied Medical Resources Corp. KGW Class II 2004-08-26
K041981 GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 Guidant Corporation GEI Class II 2004-08-20
K041436 SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 Terang Nusa Sdn Bhd KGO Class I 2004-08-20
K042098 SENORX INTRODUCER Senorx, Inc. GEI Class II 2004-08-19
K041995 MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY Uresil, LLC GBO Class I 2004-08-19
K040525 SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 Sontra Medical, Inc. NRJ Class II 2004-08-17
K041262 DURALITE-GL Laser Scientific GEX Class II 2004-08-13
K040307 HANSON SCAR ADE Hanson Medical, Inc. MDA Class I 2004-08-12
K033027 SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 Shining World Health Care Co., Ltd. GEI Class II 2004-08-12
K041948 SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS American Medical Systems, Inc. OTN Class II 2004-08-11
K041980 MSI S-500L RF GENERATOR Medsphere International, Inc. GEI Class II 2004-08-06
K041721 LVI AESTHETIC LASER Hoya Photonics, Inc. GEX Class II 2004-08-05
K041589 ARTHREX FIBERWIRE WITH SILK Arthrex, Inc. GAT Class II 2004-08-05
K030819 PLASMAJET SYSTEM Plasma Surgical, Ltd. GEI Class II 2004-08-05
K041710 VERSAWAVE DENTAL ER:YAG LASER SYSTEM Hoya Conbio GEX Class II 2004-08-03
K041806 PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP Depuy Mitek, A Johnson & Johnson Company GAM Class II 2004-08-03
K041340 GUIDANT MICROWAVE ABLATION SYSTEM Guidant Corporation, Cardiac Surgery NEY Class II 2004-07-28
K041103 ACNELIFT Inner Act, LLC GEX Class II 2004-07-27
K041599 COBRA ADHERE SURGICAL SYSTEM Estech, Inc. GEI Class II 2004-07-27
K041159 JMS ABSORBABLE ANCHOR AND APPLICATOR Jms, Inc. GDW Class II 2004-07-27
K033592 REPROCESSED SURGICAL SCISSORS AND GRASPERS Clearmedical, Inc. GEI Class II 2004-07-27
K041328 SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR Smith & Nephew, Inc. GEI Class II 2004-07-27
K030290 PERIOLASE ND:YAG DENTAL LASER SYSTEM Millennium Dental Technologies, Inc. GEX Class II 2004-07-26
K041665 L1-PRO SYSTEM Pelikan Technologies, Inc. FMK Class II 2004-07-23
K041583 PEEK CEMENT RESTRICTOR X-BOX Innovasis, Inc. JDK Class II 2004-07-22
K040756 THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX Implex Corp. FTM Class II 2004-07-14
K041140 ACELL UBM SURGICAL MESH ML AND MLPLUS Acell, Inc. FTM Class II 2004-07-07
K031140 WATERLASE Biolase Technology, Inc. GEX Class II 2004-07-07
K033953 OPTIMESH 500E CEMENT RESTRICTOR Spineology, Inc. JDK Class II 2004-07-06
K041681 ATRICURE DISSECTOR AtriCure, Inc. FTD Class II 2004-07-01
K041569 CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 Curelight, Ltd. GEX Class II 2004-06-30
K040364 MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH Porex Surgical, Inc. FTM Class II 2004-06-30
DEN040004 CELLERATION MIST THERAPY SYSTEM Celleration NRB Class II 2004-06-25

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