meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
32
Latest Decision
1998-04-21

Clearances · page 91 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K981220 SYSTEM 7500 ABC ELECTROSURGICAL UNIT Aspen Laboratories, Inc. GEI Class II 1998-04-21
K981090 LASERLITE DIODE SURGICAL LASER Laserlite, LLC GEX Class II 1998-04-21
K974057 DENTEK LD 15 LASERSYSTEM Dentek Lasersystems Produktions Ges.M.B.H. GEX Class II 1998-04-21
K980537 ND: YAG ACCESSORY FOR PHOTODERM SYSTEM Esc Medical Systems , Ltd. GEX Class II 1998-04-15
K981051 SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES W. L. Gore & Associates, Inc. FTL Class II 1998-04-15
K980110 ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. GEH Class II 1998-04-10
K980617 MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER Urohealth Systems, Inc. GDW Class II 1998-04-09
K980412 COLOURED POWDWR-FREE SURGICAL GLOVES Kenwell International , Ltd. KGO Class I 1998-04-08
K980142 FEATHERLITE DIODE LASER Laserlite, LLC GEX Class II 1998-04-03
K980044 XENON 300MX Perkinelmer Optoelectronics FSS Class II 1998-04-03
K980113 WALLSTENT ENTERAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. MUM Class II 1998-04-03
K980187 MLT R694 RUBY LASER SYSTEM Medical Laser Technologies , Ltd. GEX Class II 1998-04-03
K980138 SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-04-03
K974380 REJUVENESS Rejuveness Pharamceuticals, Inc. MDA Class I 1998-04-03
K980224 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 Alexander Mfg. Co. MOQ Class I 1998-04-02
K971749 EASYGO ASPIRATOR Precision Medical, Inc. BTA Class II 1998-04-01
K980155 ENDOBUTTON CONTINUOUS LOOP Smith & Nephew, Inc. GAT Class II 1998-04-01
K974172 SILGEL TOPICAL GEL SHEET Nagor , Ltd. MDA Class I 1998-03-30
K980560 FOTONA SKINPLUS LASER SYSTEM Fotona D.D. GEX Class II 1998-03-27
K980124 SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc GAP Class II 1998-03-27
K974143 KMC NEWSKIN Kmc Intl. Co. MDA Class I 1998-03-27
K980758 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS Microline Pentax, Inc. GEI Class II 1998-03-27
K974896 LASERSCOPE EL LASER SYSTEM AND ACCESSORIES Laserscope GEX Class II 1998-03-27
K974878 E3 MICROPROBE Martin Uram, MD GEX Class II 1998-03-27
K973652 DUOCLIPPER TITANIUM CLIPS Scion International, Inc. FZP Class II 1998-03-27
K980482 TRIANGLE SLING Influence, Inc. OTN Class II 1998-03-27
K980564 MEDI-GRIP (BEIGE 43)SURGICAL GLOVES Ansell Perry KGO Class I 1998-03-25
K980301 IP-16 Servizi Medico Estetici Italinai Srl. BTA Class II 1998-03-24
K974464 ORATEC SPINECATH INTRADISCAL CATHETER Oratec Interventions, Inc. GEI Class II 1998-03-19
K980001 JENASCAN Jenoptik Laser, Optik, Systeme GmbH GEX Class II 1998-03-19
K980561 DERMIUM Premier Laser Systems, Inc. GEX Class II 1998-03-19
K980313 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE Schwartz Electro-Optics, Inc. GEX Class II 1998-03-19
K974793 ELMED ESU 120 M/M DIGITAL Elmed, Inc. GEI Class II 1998-03-19
K980454 LYSONIX ASPIRATION PUMP Lysonix, Inc. BTA Class II 1998-03-18
K972225 UFR FIBEROPTIC CABLE Universal Fiberoptic Repair, Inc. FST Class II 1998-03-18
K974732 NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 Nidek, Inc. GEX Class II 1998-03-18
K963965 CTS MIDCAB STITCHER Cardiothoracic Systems, Inc. GEI Class II 1998-03-17
K980201 DIO-LIGHT LASER SYSTEM Nidek, Inc. GEX Class II 1998-03-16
K980163 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING Boston Scientific Scimed, Inc. JCT Class II 1998-03-13
K974672 MSI SURGICAL DRAPES Medical Specialty Innovations, Inc. (Msi) KKX Class II 1998-03-13
K980160 EPILASER I UPGRADE KIT Palomar Medical Products, Inc. GEX Class II 1998-03-10
K974789 COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L Lumenis, Inc. GEX Class II 1998-03-09
K980392 PSI-TEC ASPIRATOR Byron Medical BTA Class II 1998-03-05
K974354 MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE Sca Molnlycke MDA Class I 1998-03-05
K980461 SPECTRUM DESIGNS CLEFT CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-03-04
K980139 SPECTRUM DESIGNS PROFILE MALAR IMPLANT Spectrum Designs, Inc. LZK Class II 1998-03-03
K980140 SPECTRUM DESIGNS MEDIAL MALAR IMPLANT Spectrum Designs, Inc. LZK Class II 1998-03-03
K980141 SPECTRUM DESIGNS PROJECTION MALAR IMPLANT Spectrum Designs, Inc. LZK Class II 1998-03-03
K974084 GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT Getinge/Castle, Inc. FSY Class II 1998-03-03
K974900 CYNOSURE PHOTOGENICA 532 LASER Cynosure, Inc. GEX Class II 1998-02-27
K980156 SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS Surgical Laser Technologies, Inc. GEX Class II 1998-02-27
K973197 FIRE STICK H.S. Intl. Co., Inc. GEI Class II 1998-02-27
K980171 DERMASENSE PLUS DISPERSIVE ELECTRODE Horizon Medical, Inc. GEI Class II 1998-02-27
K980366 AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 Aaron Medical Industries GEI Class II 1998-02-27
K980183 PROMAX SURGICAL DRAPES AND COVERS Standard Textile Co., Inc. KKX Class II 1998-02-26
K972883 ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) Cypress Medical Products, Ltd. FXX Class II 1998-02-26
K974433 CHROMOPHARE D 500, CHROMOPHARE D 530 Berchtold Holding GmbH FSY Class II 1998-02-20
K974521 VNUS CLOSURE SYSTEM Vnus Medical Technologies, Inc. GEI Class II 1998-02-20
K980131 ALEX TA2 ERASER Light Age, Inc. GEX Class II 1998-02-17
K974299 PANACRYL ETHICON, Inc. GAM Class II 1998-02-13
K974250 VERSASTAT MULTIPOLAR SCISSORS AND CABLES Pilling Weck, Inc. GEI Class II 1998-02-11
K974381 CANDELA GENTLELASE GL DERMATOLOGICAL LASER Candela Corp. GEX Class II 1998-02-10
K974295 BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING Byron Medical KGZ Class I 1998-02-10
K974484 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE Ximed/Prosure/Injectx GEI Class II 1998-02-10
K973867 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM Schwartz Electro-Optics, Inc. GEX Class II 1998-02-10
K974229 LS-905 FIBERCHOICE ADAPTER SYSTEM Laser Peripherals, LLC GEX Class II 1998-02-10
K974783 ENCORE MARK IV POWDER FREE SURGICAL GLOVES Ansell Perry KGO Class I 1998-02-09
K971471 ELASTYREN POWDER-FREE SURGICAL GLOVE Eci Medical Technologies, Inc. KGO Class I 1998-02-09
K973172 RESPOSABLE BARE FIBERS Trimedyne, Inc. GEX Class II 1998-02-03
K974233 LYSONIX IRRIGATION SYSTEM Lysonix, Inc. GBX Class I 1998-02-03
K974553 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) 3M Healthcare GEI Class II 1998-02-03
K974320 CRYOGEN CARDIAC CRYOSURGICAL SYSTEM Cryogen, Inc. OCL Class II 1998-02-03
K974279 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) 3M Healthcare GEI Class II 1998-01-30
K973701 SOMNUS TISSUE COAGULATING ELECTRODE Somnus Medical Technologies, Inc. GEI Class II 1998-01-30
K980137 WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY Worldwide Medical Technologies, LLC LRO Class II 1998-01-30
K974356 SURGEON'S GLOVES American Health Products, Inc. KGO Class I 1998-01-29
K971829 MIS ELECTROSURGICAL ELECTRODE E-Tek, Inc. GEI Class II 1998-01-28
K974142 HM-RUBY American Lasers, Inc. GEX Class II 1998-01-28
K974098 PUBOUURETHRAL SLING ETHICON, Inc. OTN Class II 1998-01-28
K974146 PARACENTESIS CATHETER DEVICE Allegiance Healthcare Corp. GCB Class I 1998-01-28
K971966 CORONARY VEIN GRAFT TAG MARKER Med-Edge, Inc. KPK Class II 1998-01-26
K973183 WOUND DRAINAGE HOLDER R & D Medical Products, Inc. KGZ Class I 1998-01-23
K972358 ORATEC MODEL ENDOTAC PROBE Oratec Interventions, Inc. GEI Class II 1998-01-23
K974066 RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS Microline Pentax, Inc. GEI Class II 1998-01-22
K972562 BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED Electroscope, Inc. GEI Class II 1998-01-16
K974346 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM Star Medical Technologies, Inc. GEX Class II 1998-01-16
K974633 SCANTECH LASER SCANNER Phantom Technologies, Inc. GEX Class II 1998-01-16
K974460 LITE TOUCH ERBIUM LASER TREATMENT SYSTEM Lorad Corp. GEX Class II 1998-01-16
K971076 PRIMED SHOE COVERS, PRIMED HEAD COVERS Primeline Medical Products, Inc. FXP Class I 1998-01-13
K974039 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE Schwartz Electro-Optics, Inc. GEX Class II 1998-01-12
K974022 VAPR Mitek Products GEI Class II 1998-01-12
K973478 ARTHROCARE SINUS ELECTROSURGERY SYSTEM Arthrocare Corp. GEI Class II 1998-01-09
K970837 SOMNUS MODEL 6000 DISPOSABLE TISSUE COAGULATING ELECTRODE Somnus Medical Technologies, Inc. GEI Class II 1998-01-09
K970838 SOMNUS MODEL 30XX DISPOSABLE TRI-NEEDLE COAGULATING ELECTRODE Somnus Medical Technologies, Inc. GEI Class II 1998-01-09
K973584 MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM Medtech Instruments ESW Class II 1998-01-09
K974741 MANAN ACCURA NEEDLE Medical Device Technologies, Inc. GAA Class I 1998-01-08
K973828 PRIMA KTP LASER SYSTEM Nidek, Inc. GEX Class II 1998-01-05
K974647 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 Customed, Inc. KKX Class II 1998-01-05
K973890 UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE Conmedcorp GEI Class II 1998-01-02
K973764 TEMPERATURE DIAGNOSTIC ACCESSORY New Star Lasers, Inc. GEX Class II 1997-12-31

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