meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
33
Latest Decision
1996-07-30

Clearances · page 97 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961886 DRAGER GEMINA WALL-MOUNTED WORKPLACE Alm Surgical Equipment, Inc. FQO Class I 1996-07-30
K961925 POLYESTER NONABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. GAT Class II 1996-07-29
K961931 PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. GAL Class II 1996-07-29
K961970 COMMAND 2 MICOELECTRIC SURGICAL SYSTEM Stryker Corp. HWE Class I 1996-07-26
K955792 WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0 Wilo Medizintechnik Lothar Wilberg GmbH GEI Class II 1996-07-26
K961742 DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM Alm Surgical Equipment, Inc. FQO Class I 1996-07-26
K961748 MEDLITE/ERBIUM LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1996-07-26
K961454 AMMI MAGNI-GUARD American Medical Mfg., Inc. LYU Class I 1996-07-25
K961217 BODILY FLUID DISPOSAL KIT Transidyne General Corp. FXX Class II 1996-07-25
K962016 MEDLINE TITANIUM HEMOCLIPS Medline Industries, Inc. FZP Class II 1996-07-24
K961264 ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION Ethicon Endo-Surgery, Inc. GEI Class II 1996-07-19
K961959 MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc. GAA Class I 1996-07-19
K961505 BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE Conmedcorp GEI Class II 1996-07-18
K962003 TUAT SPLATTER CONTROL SHIELD SCS-300 Taut, Inc. KKX Class II 1996-07-18
K961997 USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1996-07-16
K960803 RX TEXTILES STERILE STOCKINETTE Rx Textiles, Inc. KKX Class II 1996-07-12
K960048 EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS Safetec of America, Inc. FXX Class II 1996-07-12
K961402 STS SHIELD WITH MASK Innovative Outsourcing Solutions FXX Class II 1996-07-12
K960073 EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP Safetec of America, Inc. FYA Class II 1996-07-12
K955834 SYSTEM 6500 ABC ELECTROSURGICAL UNIT Aspen Laboratories, Inc. GEI Class II 1996-07-11
K961133 SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE Somnus Medical Technologies, Inc. GEI Class II 1996-07-10
K961296 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. JCT Class II 1996-07-10
K954290 WALLSTENT ENTERAL ENDOPROTHESIS Boston Scientific Scimed, Inc. MQR Class II 1996-07-10
K961507 WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. JCT Class II 1996-07-10
K955612 RD-1200H NORMAL MODE RUBY LASER SYSTEM Spectrum Medical Technologies, Inc. GEX Class II 1996-07-09
K961632 MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1996-07-03
K961511 HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER Lifecore Biomedical, Inc. LZK Class II 1996-06-28
K961971 Q-5000 Stryker Endoscopy FSS Class II 1996-06-28
K961516 LASER PERIPHERALS INC. BARE FIBER Laser Peripherals, LLC GEX Class II 1996-06-27
K961295 SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR Sil-Med Corp. GBX Class I 1996-06-26
K961219 PERCUTANEOUS INTRODUCER SYSTEM Boston Scientific Corp GEH Class II 1996-06-21
K961197 SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES Conmedcorp GEI Class II 1996-06-21
K961210 SAM FACIAL IMPLANT W. L. Gore & Associates, Inc. LZK Class II 1996-06-19
K961389 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES R. K. Medical L. L. C. GAW Class II 1996-06-18
K961279 SHARPLAN LASERS, INC. RUBY LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1996-06-18
K955662 CANDELA Q-SWITCHED ALEXANDRITE LASERS Candela Laser Corp. GEX Class II 1996-06-14
K962030 KARL STORZ REMORGIDA FORCEPS KARL STORZ Endoscopy-America, Inc. GEI Class II 1996-06-14
K961759 CEMENT AND BONE REMOVAL KIT Maillefer Instruments S.A. HWE Class I 1996-06-13
K961810 SUPPLE PERI-GUARD PERICARDIUM Bio-Vascular, Inc. FTM Class II 1996-06-13
K961811 PERI-GUARD PERICARDIUM Bio-Vascular, Inc. FTM Class II 1996-06-13
K961812 ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES Conmedcorp GEI Class II 1996-06-13
K960045 ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE The Sewing Source, Inc. KKX Class II 1996-06-05
K961136 PULSEMASTER American Dental Technologies, Inc. GEX Class II 1996-06-03
K960086 DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM Slt-J , Ltd. GEX Class II 1996-06-03
K960905 SDL DIODE LASER SYSTEM Slt-J , Ltd. GEX Class II 1996-06-03
K961097 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES Debusk Knitting Mills, Div. Deroyal Industries GEI Class II 1996-06-03
K961440 SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH Fusion Medical Technologies, Inc. FTL Class II 1996-05-31
K961147 CLOSED FLUID COLLECTION SYSTEM B.Braun Medical, Inc. GBX Class I 1996-05-31
K961616 TELESCOPING PENEVAC (MODIFICATION) I.C Medical, Inc. GEI Class II 1996-05-28
K961863 PARACENTESIS TRAYS Tri-Med, Inc. LRO Class II 1996-05-28
K961132 SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE Somnus Medical Technologies, Inc. GEI Class II 1996-05-22
K961079 LASER PERIPHERALS INC. SCATTERFREE FIBER Laser Peripherals, LLC GEX Class II 1996-05-22
K960955 JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING Baxter Healthcare Corp GBX Class I 1996-05-22
K960821 SLT FUMICH PROBE GUIDE Surgical Laser Technologies, Inc. GEX Class II 1996-05-16
K961168 VIEWPOINT Philips Medical Systems (Cleveland), Inc. GAW Class II 1996-05-16
K961087 DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS Debusk Knitting Mills, Div. Deroyal Industries GEI Class II 1996-05-16
K954325 NEOLON NEOPRENE SURGICAL GLOVES Maxxim Medical KGO Class I 1996-05-14
K960867 FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532) B.V. Intl. S.A. GEX Class II 1996-05-14
K953083 HOSPITAL LAUNDRY SERVICES SURGICAL PACKS Hospital Laundry Services LRO Class II 1996-05-14
K960768 LASER FIBER DELIVERY/CLEANING CATHETER Cook Urological, Inc. GEX Class II 1996-05-14
K960820 SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER Sharplan Lasers, Inc. GEX Class II 1996-05-10
K961683 JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY J.J. Skinner, Inc. LRO Class II 1996-05-10
K960778 ISOLAIR APR TYPE N95 Louis M. Gerson Co., Inc. MSH Class II 1996-05-09
K961473 HM-88011 SOLID STATE ELECTR SURGICAL UNIT Hill-Med, Inc. GEI Class II 1996-05-07
K960711 ACUMED BONE GRAFT SYSTEM Acu Med, Inc. KIJ Class I 1996-05-07
K960178 COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1996-05-06
K955382 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 3M Company FXX Class II 1996-05-01
K960695 MODEL 200C ELECTROSURGICAL PROBE Zomed Intl. GEI Class II 1996-04-30
K961074 LIGHTSOURCE OR ILLUMINATOR Cuda Products Co. FSS Class II 1996-04-30
K960694 ZOMED 30F ELECTROSURGICAL PROBE Zomed Intl. GEI Class II 1996-04-30
K954171 ARCO-MBC, ARCO MC Holl Meditronics, Inc. GEI Class II 1996-04-30
K960815 DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL Dumex Medical Surgical Products, Ltd. NAD Class I 1996-04-29
K960521 SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER Sharplan Lasers, Inc. GEX Class II 1996-04-26
K960416 COMFIT MICROPTIC Wembley Rubber Products (M) Sdn Bhd KGO Class I 1996-04-26
K960407 COMFIT ORTHOPEDIC Wembley Rubber Products (M) Sdn Bhd KGO Class I 1996-04-26
K960475 MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM Luxar Corp. GEX Class II 1996-04-26
K955557 FLUID REISISTANT EYESHIELD MASK American Threshold Healthcare FXX Class II 1996-04-25
K955556 FLUID RESISTANT MASK American Threshold Healthcare FXX Class II 1996-04-25
K954824 PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE Medical Creative Technologies, Inc. KKX Class II 1996-04-23
K960579 CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER Cynosure, Inc. GEX Class II 1996-04-23
K960720 EXACTECH STERILE MODULAR DRILL BIT Exactech, Inc. HWE Class I 1996-04-23
K955513 SURGICAL MASK (NON-STERILE) United Medical Ent., Inc. FXX Class II 1996-04-22
K961071 THE MAGNUM CHIN IMPLANT Rand Scientific Corp. FWP Class II 1996-04-19
K961080 MEDIAL MALAR IMPLANT Rand Scientific Corp. LZK Class II 1996-04-19
K961124 THE NAUTILUS Rand Scientific Corp. FZE Class II 1996-04-19
K954549 SURGICAL APPAREL Global Healthcare, Inc. FYC Class II 1996-04-18
K961025 EXPANDED BODY SUTURE Medicinelodge, Inc. GAT Class II 1996-04-15
K955419 POWDER FREE TACTYLON SURGEONS GLOVE Tactyl Technologies, Inc. KGO Class I 1996-04-15
K955166 PENEVAC SI. I.C Medical, Inc. GEI Class II 1996-04-11
K955020 PENEVAC ABC HANDPIECE I.C Medical, Inc. GEI Class II 1996-04-09
K955144 RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 Radiotherapeutics Corp. GEI Class II 1996-04-07
K960476 ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE ETHICON, Inc. GEI Class II 1996-04-05
K955352 SUCTION CAUTERY PROBE Mectra Labs, Inc. GEI Class II 1996-04-05
K960413 COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT Lumenis, Inc. GEX Class II 1996-04-04
K960209 CPR HEART PACK Custom Pack Reliability GAW Class II 1996-04-04
K955011 CANDELA HCS 2000 URETHERAL WARMER CATHETER Candela Laser Corp. GEH Class II 1996-04-03
K960254 SILGEL TOPICAL GEL SHEET Rofil Medical USA, Inc. MDA Class I 1996-04-02
K960032 COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS Coherent Medical Group GEX Class II 1996-04-01
K960621 EXPANDACELL INSTRUMENT WIPE Shippert Medical Technologies Corp. GEC Class I 1996-04-01
K960456 DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY Denver Biomaterials, Inc. KDD Class I 1996-04-01

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