meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
29
Latest Decision
2006-10-26

Clearances · page 65 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061700 NEOTRACT ANCHOR Neotract, Inc. GAW Class II 2006-10-26
K061878 ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC E Surgical, LLC GEI Class II 2006-10-24
K062665 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC MSH Class II 2006-10-24
K060653 THERMACLEAR Dermacare, Inc. GEX Class II 2006-10-24
K060414 KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE Kmi Kolster Methods, Inc. GAW Class II 2006-10-23
K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS United States Surgical, A Division of Tyco Healthc GDW Class II 2006-10-23
K061754 BARD COMPOSITE L/P MESH Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 2006-10-23
K062125 SUPERSTITCH 5F, 12F, AND EL Sutura, Inc. GAW Class II 2006-10-19
K062336 OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE Optimedica Corporation GEX Class II 2006-10-19
K063097 ENSEAL PTC TISSUE SEALING DEVICE Surgrx, Inc. GEI Class II 2006-10-18
K062949 ENSEAL PTC TISSUE SEATING SEALING DEVICE Surgrx, Inc. GEI Class II 2006-10-18
K052907 POLARCOAT Patton Surgical Corp. GEI Class II 2006-10-16
K062312 AXIOM PULSED LIGHT SYSTEM General Project S.R.L. GEX Class II 2006-10-16
K062456 NOVASPINE POWERED SUCTION PUMP PRO-1 Novaspine, LLC OMP Class II 2006-10-16
K062935 HABIB 4X LAPAROSCOPIC Rita Medical Systems GEI Class II 2006-10-13
K062696 SURGISIS, SURGISIS ES Cook Biotech, Inc. FTM Class II 2006-10-13
K062697 SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT Cook Biotech, Inc. FTL Class II 2006-10-13
K061544 STELLARTECH 100 COAGULATION SYSTEM Stellartech Research Corp. GEI Class II 2006-10-13
K061001 THERMASSAGE Thermage, Inc. GEI Class II 2006-10-12
K062663 MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Moldex/Metric, Inc. MSH Class II 2006-10-11
K060163 CARDIOFLON, CARDIOXYL Peters Surgical GAT Class II 2006-10-11
K061417 GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 Genicon GEI Class II 2006-10-10
K061660 STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE Stryker Instruments GEI Class II 2006-10-10
K062729 SURGISIS RVP RECTO-VAGINAL FISTULA PLUG Cook Biotech, Inc. FTM Class II 2006-10-10
K062257 STARION INSTRUMENTS THERMAL LITIGATING SHEARS Starion Instruments GEI Class II 2006-10-10
K062047 ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES PAJUNK GmbH Medizintechnologie GEI Class II 2006-10-05
K062337 MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR Aaron Medical Industries GEI Class II 2006-10-05
K061465 KMI CEMENT RESTRICTOR IMPLANT Kinetikos Medical, Inc. JDK Class II 2006-10-05
K062227 V.A.C. THERAPY SYSTEM Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2006-10-04
K062801 SMARTSUCTION SOLO DEVICE Haemonetics Corp. BTA Class II 2006-10-04
K062366 OPTIME, SINUSORB PGA Peters Surgical GAM Class II 2006-10-02
K062320 SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 Cook Biotech, Inc. FTM Class II 2006-10-02
K052870 INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 Kimberly-Clark Corp. NZP Class II 2006-09-29
K061850 MINI-YAG LASER American Lasers, Inc. GEX Class II 2006-09-29
K062610 CARE-E-VAC 3 Ohio Medical Corporation BTA Class II 2006-09-28
K062071 PROMETEY, MODEL G1-03 Spectrum International GEX Class II 2006-09-28
K061966 LITETOUCH DENTAL LASER SYSTEM Light Instrument, Ltd. GEX Class II 2006-09-27
K060787 TATTOOSTAR FAMILY Asclepion Laser Technologies GmbH GEX Class II 2006-09-27
K061422 SURGICAL DRAPES Austin Medical, Inc. KKX Class II 2006-09-25
K061618 COOLTOUCH, MODEL CTEV New Star Lasers, Inc. GEX Class II 2006-09-25
K062210 COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 New Star Lasers, Inc. GEX Class II 2006-09-25
K062072 PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES PAJUNK GmbH Medizintechnologie GEI Class II 2006-09-22
K061473 SURGI-WRAP MAST BIORESORBABLE SHEET Mast Biosurgery USA, Inc. FTL Class II 2006-09-21
K062423 OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM Omniguide, Inc. GEX Class II 2006-09-21
K061690 SURGICAL HEADLIGHT Gulf Medical Fiberoptics FST Class II 2006-09-15
K061864 DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 Dukal Corp. FXX Class II 2006-09-15
K061877 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM Boston Scientific Corp MQR Class II 2006-09-15
K062458 ETHMOID SINUS SPACER Acclarent, Inc. KAM Class I 2006-09-15
K061225 STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS Stryker Corp. GEI Class II 2006-09-14
K061824 TORNIER CEMENT RESTRICTOR Tornier LZN Class II 2006-09-14
K060329 ENDOFAST RELIANT SYSTEM Endogun Medical Systems FTL Class II 2006-09-11
K061835 STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE Stryker Instruments GEI Class II 2006-09-08
K062048 AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM Aesthera Corporation GEX Class II 2006-09-07
K053540 INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE Intermedic Arfran, SA GEX Class II 2006-09-06
K061884 BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 Bovie Medical GEI Class II 2006-09-06
K060948 PORTRAIT PSR3 Rhytec Incorporated GEI Class II 2006-09-05
K061635 MSD BIPOLAR FORCEPS Medtronic Sofamor Danek GEI Class II 2006-09-05
K060165 AXYAFLEX POLYESTER SUTURE Axya Medical, Inc. GAT Class II 2006-09-01
K061649 POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH Power Medical Interventions, Inc. GDW Class II 2006-09-01
K062307 XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS Anulex Technologies, Inc. GAT Class II 2006-09-01
K062225 HALO COAGULATION CATHETER Barrx Medical, Incorporated GEI Class II 2006-08-28
K062175 CRYOCARE CN2 SYSTEM Endocare, Inc. GEH Class II 2006-08-28
K053451 LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); Moeller Medical GmbH & Co. KG QPB Class II 2006-08-25
K062140 SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 Cryocath Technologies, Inc. OCL Class II 2006-08-24
K062248 AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM North American Clinical Lasers, Ltd. GEX Class II 2006-08-17
K060372 INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 Intra Lase Corp. GEX Class II 2006-08-16
K061716 PRESTIGE AMERITECH FACE MASK Prestige Ameritech FXX Class II 2006-08-14
K061425 PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 Cambridge Endoscopic Devices GEI Class II 2006-08-10
K061975 PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK Acmi Corporation GEI Class II 2006-08-10
K061367 BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 Blue Sky Medical Group Incorporated OMP Class II 2006-08-10
K061491 LAC-MAC INNERBLOC O.R. GOWN Lac Mac, Ltd. FYA Class II 2006-08-09
K062008 ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) Niti Medical Technologies , Ltd. FZP Class II 2006-08-09
K060367 TENOLIG Fournitures Hospitalieres Industrie GAT Class II 2006-08-09
K061589 SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY Solarc Systems, Inc. FTC Class II 2006-08-04
K062057 U-CLIP DEVICE, MODEL NC65 Medtronic Vascular FZP Class II 2006-08-02
K061373 VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 Vnus Medical Technologies, Inc. GEI Class II 2006-08-01
K061455 DORNIER MEDILAS H 20 LASER Dornier Medtech America, Inc. GEX Class II 2006-08-01
K061762 TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N Cardinal Health, Inc. KKX Class II 2006-08-01
K060966 COOLTOUCH VARIA ND:YAG LASER SYSTEM Cooltouch, Inc. GEX Class II 2006-07-31
K061865 FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 Guidant Corp. NEY Class II 2006-07-27
K061784 INSORB ABSORBABLE STAPLE, MODEL 1020 Incisive Surgical, Inc. GDW Class II 2006-07-26
K060471 FSSB NYLON SURGICAL SUTURES Fssb Chirurgische Nadeln GmbH GAR Class II 2006-07-26
K060018 TRULENE MESH Sutures India Pvt., Ltd. FTL Class II 2006-07-26
K060769 HYDROMARK BIOPSY SITE MARKER Biopsy Sciences, LLC NEU Class II 2006-07-25
K052668 OR SPECIFIC BIG CASE BACK TABLE COVER Or Specific, Inc. KKX Class II 2006-07-24
K061470 DEL SOL BLUE LIGHT THERAPY SYSTEM Edge Systems Corporation GEX Class II 2006-07-20
K061704 OPTILENE MESH Aesculap, Inc. FTL Class II 2006-07-19
K061909 HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 Omniguide, Inc. GEX Class II 2006-07-19
K061510 SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. GEH Class II 2006-07-18
K060859 COMPOUND W FREEZE OFF WART REMOVAL SYSTEM OraSure Technologies, Inc. GEH Class II 2006-07-18
K061307 BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK Aaron Medical Industries GEI Class II 2006-07-18
K053215 SURGICAL MESH SYSTEM Nuvasive, Inc. FTL Class II 2006-07-17
K061037 PDS PLUS ANTIBACTERIAL SUTURE ETHICON, Inc. NEW Class II 2006-07-14
K053656 TYRX ANTIMICROBIAL MESH Tyrx Pharma, Inc. FTL Class II 2006-07-14
K060232 TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES Trokamed GmbH GEI Class II 2006-07-12
K061698 MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR Life Spine JDK Class II 2006-07-12
K061593 ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1 AtriCure, Inc. OCL Class II 2006-07-12
K061859 INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS Inovel, LLC MSH Class II 2006-07-12
K061788 BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories OMP Class II 2006-07-11
K061133 SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S Novaspine, LLC BTA Class II 2006-07-11

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