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
1996-04-01

Clearances · page 98 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960481 SOFT TISSUE AUGMENTATION TUBE Tissue Technologies, Inc. FTL Class II 1996-04-01
K960387 UROSPROBE SYSTEM, MODEL 1000 Uros Corp. GEH Class II 1996-04-01
K954905 CB DIODE/532 LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1996-03-29
K960236 CPR LAP SPONGES Custom Pack Reliability GDY Class I 1996-03-28
K960653 MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) ETHICON, Inc. GAN Class II 1996-03-28
K960255 CERAMIC BLADE ELECTRODE Utah Medical Products, Inc. GEI Class II 1996-03-27
K955636 SENTRY DISPOSABLE DISPERSIVE ELECTRODE Sentry Medical Products, Inc. JOS Class II 1996-03-27
K951876 PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES Xintec Corporation GEX Class II 1996-03-25
K951935 PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES Xintec Corporation GEX Class II 1996-03-25
K960808 CONMED SELECT ONE LAPAROSCOPY ELECTRODE Conmedcorp GEI Class II 1996-03-21
K960426 MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER Medical Components, Inc. GBW Class I 1996-03-21
K960852 HALL MODULAR ACETABULAR REAMER SYSTEM Linvatec Corp. HWE Class I 1996-03-20
K960354 PERMAMESH-D HYDROXYLAPATITE MATRIX Ceramed Corp. LZK Class II 1996-03-20
K960362 PERMAMESH HYDROXYLAPATITE MATRIX Ceramed Corp. LZK Class II 1996-03-20
K945302 SLOAN STA-DRI PANT PROTECTOR Sloan Corp. LYU Class I 1996-03-19
K955833 NIOMED SURGICAL CAPS Amerasia Corp. FYF Class I 1996-03-15
K960219 PROLEX MESH Advanced Surgical Innovations, Inc. FTL Class II 1996-03-15
K960349 PERMARIDGE HYDROXYLAPATITE MATRIX Ceramed Corp. FWP Class II 1996-03-13
K955339 HYDROLOGY 5000 Northgate Technologies, Inc. GBX Class I 1996-03-13
K955863 ALLDRESS MULTI LAYERED WOUND DRESSING Molnlycke/Scott Health Care NAD Class I 1996-03-13
K954556 SURGICAL CAP Thai Disposable Products Co., Ltd. FYF Class I 1996-03-12
K960242 CPR EYE TRAY Custom Pack Reliability KKX Class II 1996-03-12
K955872 VOLMED OPERATION DRAPE Medal Intl. Sales Co., LLC KKX Class II 1996-03-12
K960099 PENROSE DRAIN MODELS 6001 - 6007 Sil-Med Corp. GCY Class I 1996-03-11
K954597 RIGHT ANGLE LASER FIBERS Trimedyne, Inc. GEX Class II 1996-03-11
K960569 DISPOSABLE PATIENT RETURN ELECTRODE Erbe USA, Inc. GEI Class II 1996-03-11
K943014 BALLOON ELECTROSURGICAL PROBES AND DEVICES Ximed Medical Systems GEI Class II 1996-03-11
K960473 AESCULAP POWER SYSTEM HANDPIECE Aesculap, Inc. GET Class I 1996-03-07
K954747 NIOMED BARRIER GOWNS Amerasia Corp. FYC Class II 1996-03-06
K960009 STORZ S2050 SERIES BIPOLAR FORCEPS Storz Instrument Co. GEI Class II 1996-03-06
K960554 DETACHATIP THORACOSCOPIC SCISSORS Microsurge, Inc. GEI Class II 1996-03-05
K960327 NYLON NOABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. GAR Class II 1996-03-04
K960328 SILK NONABSORBABLE SURGICAL SUTURES USP R. K. Medical L. L. C. GAP Class II 1996-03-04
K955764 VALLEY FORGE BIPLOAR LOOP Valley Forge Scientific Corp. GEI Class II 1996-03-01
K955862 FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 Full Spectrum, Inc. GEX Class II 1996-03-01
K955664 STERILIZED TRI BLOCK POLYMER GEL SHEET Silipos, Inc. MDA Class I 1996-02-28
K955631 ORTHOPLUG HARD BONE DESIGN Sunmed, Inc. LZN Class II 1996-02-27
K955723 STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) Davis & Geck, Inc. GAQ Class II 1996-02-27
K954808 USSC POLYPROPLENE SUTURE United States Surgical, A Division of Tyco Healthc GAW Class II 1996-02-27
K955632 ORTHOPLUG SOFT BONE DESIGN Sunmed, Inc. LZN Class II 1996-02-27
K955621 SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER Sharplan Lasers, Inc. GEX Class II 1996-02-27
K960455 BIPOLAR SUCTION COAGULATOR Kirwan Surgical Products, Inc. GEI Class II 1996-02-27
K955747 USSC NONABSORBABLE SUTURES United States Surgical, A Division of Tyco Healthc GAT Class II 1996-02-27
K955599 STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE Stryker Corp. GDY Class I 1996-02-22
K955041 INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM Instent, Inc. ESW Class II 1996-02-21
K955131 MEDLITE LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1996-02-20
K960296 4000 ETM Aspen Laboratories, Inc. GEI Class II 1996-02-20
K955347 ULTRAFLEX Boston Scientific Corp ESW Class II 1996-02-16
K953851 CERALAS F ND:YAG LASER SYSTEM Ceram Optec, Inc. GEX Class II 1996-02-16
K955758 INDIGO MEDICAL MODEL IDL 830E Indigo Medical, Inc. GEX Class II 1996-02-16
K954665 GLYCAR STAPLE STRIPS Glycar, Inc. FTL Class II 1996-02-14
K955623 OLYMPUS BIPOLAR FORCEPS Olympus America, Inc. GEI Class II 1996-02-13
K955734 LASERSONICS PARASCAN DOSIMETER DEVICE Heraeus Surgical, Inc. GEX Class II 1996-02-13
K955474 NEO-PNEUMOCATH Intra Special Catheters GmbH GBX Class I 1996-02-13
K953128 SUTURE CORD Phoenix Biomedical Corp. GAS Class II 1996-02-09
K960019 RETRACTOR ARM CLAMP Biopsys Medical, Inc. FWZ Class I 1996-02-09
K955083 VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION) Cryosurgery, Inc. GEH Class II 1996-02-08
K952535 ACUFEX ENDOBUTTON TAPE Acufex Microsurgical, Inc. GAT Class II 1996-02-08
K955681 AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE Geiger Instrument Co., Inc. GEI Class II 1996-02-08
K954703 MEDI-FRIG Ellman Intl., Inc. GEH Class II 1996-02-08
K955750 TELETOM Berchtold Holding GmbH FQO Class I 1996-02-08
K955167 SURGITRON Ellman Intl., Inc. GEI Class II 1996-02-08
K955505 OPTI-DRAIN MULTI-USE DRAINAGE CATHETER Navarre Biomedical , Ltd. GBX Class I 1996-02-07
K954727 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) Surgical Laser Technologies, Inc. GEX Class II 1996-02-05
K954872 CANDELA CRYO-PROBE HOLDER Candela Laser Corp. GEH Class II 1996-02-05
K953968 AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) Aesculap, Inc. HWE Class I 1996-02-05
K953585 SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER Schwartz Electro-Optics, Inc. GEX Class II 1996-02-05
K954934 CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE Candela Laser Corp. GEX Class II 1996-02-02
K955683 RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY Contour Fabricators of Florida, Inc. MJG Class I 1996-02-01
K954169 HANAULUX BLUE 30 & 80 Heraeus Med GmbH FSY Class II 1996-02-01
K955836 VALLEYLAB COATED ELECTRODES Valleylab, Inc. GEI Class II 1996-02-01
K955364 SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. OXD Class II 1996-02-01
K954013 TRILASE 2940 ERBIUM LASER Schwartz Electro-Optics, Inc. GEX Class II 1996-01-31
K955510 X6000D SILENT SUN LIGHT SOURCE Products For Medicine FST Class II 1996-01-31
K953609 PRODEK Sutures , Ltd. GAW Class II 1996-01-31
K954483 STRYKER SAGITTAL SAW ATTACHMENT Stryker Instruments GFA Class I 1996-01-30
K955261 NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) Msb , Ltd. GEI Class II 1996-01-30
K954002 AMPRI Ampri Rubberware Industries Sdn Bhd KGO Class I 1996-01-29
K955751 PRIME FEMORAL CEMENT PLUG Orthopaedic Innovations, Inc. LZN Class II 1996-01-26
K955433 DURALASTIC SILICONE TUBING Allied Biomedical Corp. KGZ Class I 1996-01-26
K955007 APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM Applied Optronics Corp. GEX Class II 1996-01-26
K955861 MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER Microquartz Medical, Inc. GEX Class II 1996-01-26
K953754 GLOBAL HEALTHCARE FACE MASK Global Healthcare, Inc. FXX Class II 1996-01-26
K955014 APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE Applied Optronics Corp. GEX Class II 1996-01-26
K953670 ACCUSCAN MODEL C CO2 LASER SCANNER Reliant Technologies, Inc. GEX Class II 1996-01-26
K954195 INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS Indigo Medical, Inc. GEX Class II 1996-01-25
K955163 DISSECTION PROBE Origin Medsystems, Inc. GEI Class II 1996-01-24
K954911 OMEGA ULTRASCAN Gyne-Tech Instrument Corp. GEX Class II 1996-01-24
K955494 GORE-TEX DUALMESH BIOMATERIAL WITH HOLES W. L. Gore & Associates, Inc. FTL Class II 1996-01-24
K954454 NIOMED SURGICAL HOOD Amerasia Corp. FYF Class I 1996-01-23
K955463 GRIP-A-BOOTS Sil-Med Corp. LXZ Class I 1996-01-23
K954455 NIOMED BOUFFANT CAPS Amerasia Corp. FYF Class I 1996-01-23
K952961 BODY FLUID BARRIER KIT Lhb Industries, Inc. FXX Class II 1996-01-23
K955618 BIPOLAR CUTTER Cook Urological, Inc. GEI Class II 1996-01-22
K955174 SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY Sodem Diffusion SA GET Class I 1996-01-22
K952489 6 WATT HOLMIUM LASER SYSTEM New Star Lasers, Inc. GEX Class II 1996-01-22
K954904 MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER Microquartz Medical, Inc. GEX Class II 1996-01-22
K955168 SURGICAL CUTTER Promex, Inc. GEI Class II 1996-01-22
K955098 3M MINI-DRIVER ELECTRIC SYSTEM 3M Company HWE Class I 1996-01-22
K953271 ELMED RF-ALERT Elmed, Inc. GEI Class II 1996-01-18

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