meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
30
Latest Decision
2004-06-25

Clearances · page 72 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041077 IMALUX OCT PROBE GUIDE Imalux Corporation KKX Class II 2004-06-25
K031368 POWDERED LATEX SURGEON'S GLOVES Cephas Medical Private , Ltd. KGO Class I 2004-06-22
K040135 THERMAGE THERMACOOL SYSTEM Thermage, Inc. GEI Class II 2004-06-21
K040617 RELIANT LASER SYSTEM II Reliant Technologies, Inc. GEX Class II 2004-06-15
K030831 LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS Modern Medical Equipment Mfg., Ltd. GEI Class II 2004-06-15
K040835 PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 Pm Devices, Inc. FTM Class II 2004-06-15
K041331 BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER Biopsy Sciences, LLC GDW Class II 2004-06-15
K032327 MODERN MEDICAL BIPOLAR FORCEPS Modern Medical Equipment Mfg., Ltd. GEI Class II 2004-06-15
K041383 STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 Stellartech Research Corp. GEI Class II 2004-06-14
K040794 INCUBATOR CAPE Wrapped IN Comfort MMP Class II 2004-06-10
K041212 HOUVA 3 PHOTOTHERAPY SYSTEM National Biological Corp. FTC Class II 2004-06-09
K040171 MICRODERM, MODEL/VERSION 3.5 Visiomed AG PSN Class II 2004-06-08
K040333 VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS Valumax Intl., Inc. FXX Class II 2004-06-07
K040638 VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 Vnus Medical Technologies, Inc. GEI Class II 2004-06-07
K041216 SMITH & NEPHEW ULTRABRAID SUTURE Smith & Nephew, Inc. GAT Class II 2004-06-07
K040789 DURABRAID SUTURE Smith & Nephew, Inc. GAT Class II 2004-06-04
K041048 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE Internacional Farmaceutica, S.A. DE C.V. NEW Class II 2004-06-04
K040868 SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH Genzyme Corp. FTM Class II 2004-06-04
K041347 MODIFICATION TO EN-BLOC BIOPSY SYSTEM Neothermia Corp. GEI Class II 2004-06-04
K033985 PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 Pm Devices, Inc. FTM Class II 2004-06-04
K040699 LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) Megadyne Medical Products, Inc. GEI Class II 2004-06-04
K040720 SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM Power Medical Interventions, Inc. GDW Class II 2004-06-03
K041201 ULTRACLIP II MR Inrad GDW Class II 2004-06-03
K041199 MEDI-PUMP ASPIRATOR, MODEL 1615 Thomas Industries BTA Class II 2004-06-01
K040659 MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM Mccue Plc GEX Class II 2004-06-01
K032397 DUAL YELLOW LASER, MODEL DUAL YELLOW D10B Norseld Pty., Ltd. GEX Class II 2004-05-27
K041095 PHOTOSILK PULSED LIGHT SYSTEM Cynosure, Inc. GEX Class II 2004-05-26
K040809 CRYMED CRYO-ABLATOR Crymed Technologies, Inc. GEH Class II 2004-05-21
K040735 ALM X'TEN (X10) SURGICAL LIGHT SYSTEM Alm S.A. FSY Class II 2004-05-21
K040433 SINON Wavelight Laser Technologie AG GEX Class II 2004-05-19
K040477 MONODERM Surgical Specialties Corp GAM Class II 2004-05-18
K041154 S-SCORT...JR QUICKDRAW, MODEL 2400 Sscor BTA Class II 2004-05-18
K041058 MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS Misonix, Inc. QPB Class II 2004-05-17
K041176 URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM Sofradim Production OTN Class II 2004-05-17
K040384 MYDON C Wavelight Laser Technologie AG GEX Class II 2004-05-14
K032965 LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE Modern Medical Equipment Mfg., Ltd. GEI Class II 2004-05-13
K033003 SUCTION COAGULATOR Modern Medical Equipment Mfg., Ltd. GEI Class II 2004-05-13
K040990 MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS Walter Lorenz Surgical, Inc. NEU Class II 2004-05-13
K033990 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM Alveolus, Inc. JCT Class II 2004-05-12
K040424 LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 Clarus Medical, LLC GEX Class II 2004-05-11
K040602 SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS Design Standards Corp. FZP Class II 2004-05-10
K033324 COMPRESSION ANASTOMOSIS CLIP (CAC) Niti Medical Technologies , Ltd. FZP Class II 2004-05-10
K032400 LAFACI Vision Pro, LLC FYD Class II 2004-05-07
K040641 ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 Epicor Medical, Inc. NTB Class II 2004-05-05
K030810 COOLAN 300 Coolanalgesia , Ltd. GEX Class II 2004-05-05
K040294 LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 Photo Medex, Inc. GEX Class II 2004-05-05
K040276 QUANTUM CEMENT RESTRICTOR Quantum Orthopedics JDK Class II 2004-04-30
K040289 SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER Cynosure, Inc. GEX Class II 2004-04-30
K040998 MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH Sofradim Production FTL Class II 2004-04-29
K040690 SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc. OCL Class II 2004-04-29
K040282 ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID Internacional Farmaceutica, S.A. DE C.V. GAM Class II 2004-04-29
K040785 CONCERTO BIPOLAR NEEDLE ELECTRODE Boston Scientific Corp GEI Class II 2004-04-28
K040989 RITA SYSTEMS Rita Medical Systems GEI Class II 2004-04-28
K033905 PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING Cardinalhealth KGO Class I 2004-04-27
K040764 STRYKER T4 HYTREL ZIPPER TOGA Stryker Corp. FYA Class II 2004-04-27
K022256 SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN Tucker & Associates FXX Class II 2004-04-26
K040821 COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical FZP Class II 2004-04-23
K040727 CRYO 5 Zimmer Elektromedizin GmbH GEX Class II 2004-04-23
K040148 RESOLUTION HEMOSTASIS CLIPPING DEVICE Boston Scientific Corp MCH Class II 2004-04-22
K040584 NMX-1000 Neomedix Corp. GEI Class II 2004-04-22
K040131 COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM New Star Lasers, Inc. GEX Class II 2004-04-20
K040855 INSTRUMED LAPAROSCOPE AND ACCESSORIES Instrumed International, Inc. GEI Class II 2004-04-16
K040163 MICROVASCULAR ANASTOMOTIC DEVICE Synovis Micro Companies Alliance, Inc. MVR Class II 2004-04-16
K033183 RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 Curelight, Ltd. GEX Class II 2004-04-15
K040621 ACELL UBM SURGICAL MESH Acell, Inc. FTM Class II 2004-04-14
K040787 MODIFICATION TO SURGICAL MESH POLYMERIC Boston Scientific OTN Class II 2004-04-14
K040004 ORTHOCORD SUTURE Depuy Mitek NEW Class II 2004-04-13
K040763 RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE Resect Medical, Inc. GEI Class II 2004-04-08
K040706 GEL MARK IV Senorx, Inc. NEU Class II 2004-04-08
K040055 POLYLASE LP Ddc Technologies, Inc. GEX Class II 2004-04-07
K033946 LOVELY SYSTEM Msq (M2) , Ltd. FTC Class II 2004-04-05
K032797 DELIGHT DENTAL ER: YAG LASER SYSTEM Hoya Photonics, Inc. GEX Class II 2004-04-05
K040234 LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM Photo Medex, Inc. GEX Class II 2004-04-02
K033888 MSI MODEL S-500 RF GENERATOR Medsphere International, Inc. GEI Class II 2004-04-02
K040240 STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) Stellartech Research Corp. GEI Class II 2004-04-01
K033337 ULTRAPRO MESH ETHICON, Inc. FTL Class II 2004-04-01
K033072 LUCENTLITE, MODEL IMD 010 Industrial & Medical Design, Inc. GEX Class II 2004-04-01
K040081 PALOMAR LUXV HANDPIECE Palomar Medical Technologies, Inc. GEX Class II 2004-04-01
K033979 CORLINK AUTOMATED ANASTOMOTIC SYSTEM By-Pass Makafim , Ltd. FZP Class II 2004-03-31
K034011 GEMINI SURGICAL LASER SYSTEM & ACCESSORIES Laserscope GEX Class II 2004-03-30
K040005 PROFILE 2000/3000 LASER SYSTEM Sciton, Inc GEX Class II 2004-03-29
K040109 HEMORRHAGE OCCLUDER PIN Tools For Surgery, LLC GDW Class II 2004-03-25
K040156 IFL PROFESSIONAL SYSTEM, MODEL C100 Cyden Limited GEX Class II 2004-03-24
K040398 SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS Power Medical Interventions, Inc. GDW Class II 2004-03-24
K032864 CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 Biolitec, Inc. GEX Class II 2004-03-19
K032863 CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 Biolitec, Inc. GEX Class II 2004-03-19
K032896 ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02 Anson Medical , Ltd. FZP Class II 2004-03-17
K040119 PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION Synovis Surgical Innovations FTM Class II 2004-03-17
K040538 BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 American Medical Systems, Inc. OTN Class II 2004-03-17
K033933 POWERLITE 600 EX SYSTEM Preswede AB GEX Class II 2004-03-16
K040503 ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR Wrp Asia Pacific Sdn. Bhd. KGO Class I 2004-03-16
K033762 SERRALAPG Serral, S.A. DE C.V. GAM Class II 2004-03-15
K040472 FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE Teleflex Medical GAT Class II 2004-03-15
K033880 ELECTRO-LUBE Mectra Labs, Inc. GEI Class II 2004-03-10
K033549 STARLUX PULSED LIGHT SYSTEM Palomar Medical Products, Inc. GEX Class II 2004-03-10
K032459 PROFILE 1320 LASER SYSTEM Sciton, Inc GEX Class II 2004-03-09
K034029 TI CLIP APPLIER Gyrx, LLC NJC Class II 2004-03-05
K033251 THE FRIENDLYLIGHT ND: YAG LASERS Innotech USA, Inc. GEX Class II 2004-03-02
K040279 VIVARING MICROWAVE ABLATION PROBE Vivant Medical, Inc. GEI Class II 2004-03-02
K040338 ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 Arthrocare Corp. GEI Class II 2004-03-01

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