meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
35
Latest Decision
1997-12-29

Clearances · page 92 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K973736 AESCULAP HILAN MOTOR SYSTEM Aesculap, Inc. HWE Class I 1997-12-29
K973719 MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER Continuum Biomedical, Inc. GEX Class II 1997-12-23
K963969 INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB Indigo Medical, Inc. GEX Class II 1997-12-23
K974068 PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL Tecnol Medical Products, Inc. MSH Class II 1997-12-22
K973686 ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. GEH Class II 1997-12-22
K973603 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM Schwartz Electro-Optics, Inc. GEX Class II 1997-12-19
K973554 VALLEY FORGE BIPOLAR BALL TIP ELECTRODE Valley Forge Scientific Corp. JOS Class II 1997-12-19
K973610 SKYVAL Pyramid Air Systems FYD Class II 1997-12-19
K972915 ERBIUM 2000 LASER FAMILY Phantom Technologies, Inc. GEX Class II 1997-12-19
K973618 SOMNOPLASTY SYSTEM Somnus Medical Technologies, Inc. GEI Class II 1997-12-19
K970795 SHANG HO Shang HO Industrial Corp. , Ltd. KGO Class I 1997-12-18
K973682 BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, Electroscope, Inc. GEI Class II 1997-12-18
K972634 ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. GDY Class I 1997-12-17
K973621 PRE-VIEW CHOLANGIOGRAPHY CLAMP Nashville Surgical Instruments GBZ Class I 1997-12-17
K973773 DAPELLE HAIR REMOVER Wellquest Intl., Inc. KCX Class I 1997-12-17
K973648 MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM Richard Wolf Medical Instruments Corp. GEI Class II 1997-12-17
K973699 ULTRALON POWDER FREE LATEX SURGICAL GLOVE Johnson & Johnson Medical, Inc. KGO Class I 1997-12-16
K971118 ARAGO Premier Laser Systems, Inc. GEX Class II 1997-12-16
K973470 COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS Lumenis, Inc. GEX Class II 1997-12-09
K973576 EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM Epulse Technologies, Inc. GEX Class II 1997-12-09
K973461 ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE Ansell Perry KGO Class I 1997-12-09
K973384 ETHICON NON-STICK BIPOLAR FORCEPS ETHICON, Inc. GEI Class II 1997-12-05
K973703 JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN Allegiance Healthcare Corp. GBX Class I 1997-12-04
K971920 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) Customed, Inc. FYA Class II 1997-12-04
K972767 CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER Candela Corp. GEX Class II 1997-12-04
K973146 MENTOR SUPER ABSORBENT DRAPE Mentor Ophthalmics, Inc. KKX Class II 1997-12-04
K973354 SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) Sharplan Lasers, Inc. GEX Class II 1997-12-04
K973324 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM Star Medical Technologies, Inc. GEX Class II 1997-12-03
K973340 TWEEZER-TYPE EPILATOR Mobit, Inc. KCX Class I 1997-12-03
K972112 INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 Taut, Inc. GBW Class I 1997-12-01
K973268 MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM Microaire Surgical Instruments, Inc. BTA Class II 1997-11-26
K973295 BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 Richard Wolf Medical Instruments Corp. GEI Class II 1997-11-26
K973462 SOFTFORM FACIAL IMPLANT Tissue Technologies, Inc. FTL Class II 1997-11-24
K973190 ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES Cryomedical Sciences, Inc. GEI Class II 1997-11-21
K970306 MARKMAN TEMPLATE SYSTEM Barry Markman, M.D. GAH Class I 1997-11-20
K973271 SKAR-KARE Target Health, Inc. MDA Class I 1997-11-19
K972109 SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER General Surgical Innovations FZW Class I 1997-11-14
K973341 HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE Richard Wolf Medical Instruments Corp. GEI Class II 1997-11-13
K973573 DURALASTIC ANATOMICAL NASAL IMPLANTS Hanson Medical, Inc. FZE Class II 1997-11-13
K972510 PIVOTAL SCISSOR Urohealth Systems, Inc. GEI Class II 1997-11-13
K973498 CYNOSURE PHOTOGENICA ER LASER Cynosure, Inc. GEX Class II 1997-11-13
K973560 BONE GRAFT HARVESTER Ds Mfg., Inc. HWE Class I 1997-11-12
K973346 UNCOATED ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. GEI Class II 1997-11-07
K973575 DURALASTIC ANATOMICAL CHIN IMPLANTS Hanson Medical, Inc. FWP Class II 1997-11-07
K971507 O2 BOOT Gwr Medical, Llp KPJ Class II 1997-11-07
K973502 IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT Implantech Associates, Inc. LZK Class II 1997-11-07
K973158 ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE Oratec Interventions, Inc. GEI Class II 1997-11-05
K970352 SMARTVAC SMOKE EVACUATION SYSTEM Isomedix Operations, Inc. FYD Class II 1997-11-04
K973082 VENTRAL WALL DEFECT REDUCTION SILO Specialty Surgical Products, Inc. FTL Class II 1997-11-04
K971912 PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES Xintec Corporation GEX Class II 1997-11-03
K972860 CURVTEK TSR SYSTEM Biolectron, Inc. HSZ Class I 1997-10-31
K973174 SONIQUE HAIR REMOVER Global TV Concepts, Ltd. KCX Class I 1997-10-30
K973179 FEMINIQUE SONIC HAIR REMOVER Global TV Concepts, Ltd. KCX Class I 1997-10-30
K973173 POWERSTAR BIPOLAR SCISSORS ETHICON, Inc. GEI Class II 1997-10-29
K970143 C4 Clinicon Corp. GEX Class II 1997-10-29
K973297 COSMAN COAGULATOR (CC-1) SYSTEM Radionics, Inc. GEI Class II 1997-10-29
K973431 LASETTE Cell Robotics, Inc. GEX Class II 1997-10-28
K972872 DERMA K LASER SYSTEM Esc Medical Systems , Ltd. GEX Class II 1997-10-28
K973234 MIDAS TOUCH ELECTROSURGICAL ELECTRODE Iti Medical Technologies, Inc. GEI Class II 1997-10-27
K972918 RAPID FIRE HAIR IMPLANTER CAROUSEL Apex Medical Products, LLC GAH Class I 1997-10-27
K973574 DURALASTIC ANATOMICAL MALAR IMPLANT Hanson Medical, Inc. LZK Class II 1997-10-24
K971588 EVI SUTURED-CLIP APPLIER Elective Vascular Intervention Inc. (Evi) FZP Class II 1997-10-24
K972621 PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1997-10-24
K973466 HANAULUX BLUE 75 AND HANAULUX BLUE 120 Heraeus Med GmbH FSY Class II 1997-10-24
K972028 DERMASCAN SURGICAL LASER SCANNER Esc Medical Systems , Ltd. GEX Class II 1997-10-24
K972695 FINALLY FREE Mehl/Group Marketing KCX Class I 1997-10-22
K972760 LINK, ACETABULAR REVISION MESH CUP Link America, Inc. JDJ Class II 1997-10-22
K973572 KELOCOTE SCAR GEL AND KELOCOTE LASER GEL Hanson Medical, Inc. MDA Class I 1997-10-21
K972832 PROVISION SURGICAL HELMET SYSTEM Depuy, Inc. FYA Class II 1997-10-21
K972745 TITANIUM HEMOSTATIC CLIP Eisner USA, Inc. MCH Class II 1997-10-21
K972765 NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER American Laser Medical GEX Class II 1997-10-21
K972071 BOVIE MODEL X40 Maxxim Medical GEI Class II 1997-10-21
K972277 DIGIFLEX SURGICAL GLOVES Hms Services, Inc. KGO Class I 1997-10-21
K973110 LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD Ludlow Technical Products GEI Class II 1997-10-21
K971392 HISTOFREEZER VERRUCA PLANA OraSure Technologies, Inc. GEH Class II 1997-10-21
K970893 ULTRASOUND TRANSDUCER DRAPE Protek Medical Products, Inc. FYA Class II 1997-10-20
K970889 ULTRASOUND TRANSDUCER DRAPE Protek Medical Products, Inc. KKX Class II 1997-10-20
K973022 ISLAND BIOSURGICAL INC. BNS KIT #1 & #2 Island Biosurgical, Inc. OTN Class II 1997-10-20
K972558 BIPOLAR SCISSORS Enable Medical Corp. GEI Class II 1997-10-07
K972561 NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY American Laser Medical GEX Class II 1997-10-06
K972521 NAVIGATOR (STYLET) 2006 Sil-Med Corp. GAH Class I 1997-10-01
K972635 ULTRACELL SUCTION SPONGE Ultracell Medical Technologies, Inc. GBX Class I 1997-10-01
K972662 CRYOGEN CRYOSURGICAL SYSTEM Cryogen, Inc. GEH Class II 1997-10-01
K972703 REDYROB-CLOSED WOUND DRAINAGE SYSTEM B.Braun Medical, Inc. GCY Class I 1997-10-01
K972597 PMT NEW BEGINNINGS GELSHAPES & AMEND Pmt Corp. MDA Class I 1997-10-01
K973273 XOMED T-STENT, FRONTAL SINUS STENT Xomed, Inc. KAM Class I 1997-09-29
K970475 MM-RUBY American Lasers, Inc. GEX Class II 1997-09-29
K973379 STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS S. Jackson, Inc. FTM Class II 1997-09-25
K973159 ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR Oratec Interventions, Inc. GEI Class II 1997-09-25
K971821 UNICA 315 M CO2 SURGICAL LASER SYSTEM Reliant Technologies, Inc. GEX Class II 1997-09-25
K972368 FOTONA SKINLIGHT PLUS ND: YAG SYSTEM Medical Laser Solutions GEX Class II 1997-09-23
K970885 ULTRASOUND SYSTEMS DRAPE Protek Medical Products, Inc. MMP Class II 1997-09-22
K971917 KENTRON'S ISOLATION GOWN Kentron Health Care, Inc. FYC Class II 1997-09-19
K972008 ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES European Surgical, Inc. GEI Class II 1997-09-19
K972410 IMPERVIOUS ISOLATION GOWN Kentron Health Care, Inc. FYC Class II 1997-09-19
K972347 MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER Lumenis, Inc. GEX Class II 1997-09-19
K972325 PULSEMASTER 1000 ST DENTAL LASER SYSTEM American Dental Technologies, Inc. GEX Class II 1997-09-19
K971728 PIONEER ELEC-TROCAR DEVICE Pioneer Surgical Technology GEI Class II 1997-09-19
K972901 AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD American Biosurgical, Inc. GEI Class II 1997-09-19
K972651 IN-SLING Influence, Inc. OTN Class II 1997-09-19

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