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
1999-12-20

Clearances · page 86 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993668 LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 Laerdal Medical A/S BTA Class II 1999-12-20
K994053 STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE Stryker Instruments FYA Class II 1999-12-20
K993157 HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 Weck Closure Systems FZP Class II 1999-12-17
K993967 ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 Oratec Interventions, Inc. GEI Class II 1999-12-17
K993153 INTRALASE 600C LASER KERATOME Intra Lase Corp. GEX Class II 1999-12-17
K994010 INNOVAQUARTZ GENERAL SHAPE LASER FIBER Innovaquartz GEX Class II 1999-12-17
K992298 IRIDERM, MODEL APEX 800 Iridex Corp GEX Class II 1999-12-09
K993112 XOMED ENT RF SYSTEM Xomed, Inc. GEI Class II 1999-12-09
K992581 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDS Arthrocare Corp. GEI Class II 1999-12-09
K993314 SYNTHES LIGHT GUIDE Synthes (Usa) FQP Class II 1999-12-06
K993854 ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES Oratec Interventions, Inc. GEI Class II 1999-12-06
K993944 RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH,MAIN CABLE, DISPERSIVE ELECTRODE Rita Medical Systems GEI Class II 1999-12-02
K993215 DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE Wrp Specialty Products Sdn. Bhd. KGO Class I 1999-12-02
K993214 DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) Wrp Specialty Products Sdn. Bhd. KGO Class I 1999-12-02
K993135 IMPLANTABLE CLIP FOR GENERAL SURGERY Applied Medical Resources FZP Class II 1999-12-01
K992996 ENABLE ENDOSCOPIC BIPOLAR SCISSORS Enable Medical Corp. GEI Class II 1999-11-24
K993349 NIL, SURGEON'S GLOVE - POWDER FREE Sri Anusham Rubber Industries Pvt., Ltd. KGO Class I 1999-11-23
K992240 PILLAR MALAR IMPLANT Pillar Surgical, Inc. LZK Class II 1999-11-22
K992242 PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS Pillar Surgical, Inc. FZE Class II 1999-11-22
K992239 PILLAR CHIN IMPLANT Pillar Surgical, Inc. FWP Class II 1999-11-22
K993285 AURORA SL Premier Laser Systems, Inc. GEX Class II 1999-11-18
K983753 STAR TEMPORARY WOUND COVER Osteogenics, Inc. FTL Class II 1999-11-18
K992866 OPTILITE IX LASER SURGERY ACCESSORIES Convergent Laser Technologies GEX Class II 1999-11-18
K992510 WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Corp JCT Class II 1999-11-18
K992824 LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL Ellex Medical Pty, Ltd. GEX Class II 1999-11-17
K991993 PHACOLASE ER: YAG LASER Aesculap-Meditec GmbH GEX Class II 1999-11-17
K992931 NON-STICK BIPOLAR FORCEPS Silverglide Surgical Technologies GEI Class II 1999-11-17
K993647 UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F Unimed Surgical Products, Inc. GEI Class II 1999-11-16
K993146 DORNIER SCANNER HANDPIECE Dornier Surgical Products, Inc. GEX Class II 1999-11-08
K993242 CASTLE SURGICAL LIGHT, MODEL 3000 Getinge/Castle, Inc. FSY Class II 1999-11-08
K993459 MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Advanced Uroscience, Inc. PAG Class II 1999-11-05
K992752 SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 Pt. Maja Agung Latexindo KGO Class I 1999-11-05
K993306 NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) Paladin Medical, Inc. HAM Class II 1999-11-03
K992574 OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A Trimedyne, Inc. GEX Class II 1999-10-29
K992953 SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM Ansell Perry KGO Class I 1999-10-29
K992542 TUBULAR ELECTRODE DEVICE Conway Stuart Medical, Inc. GEI Class II 1999-10-27
K992522 SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. MDA Class I 1999-10-26
K991140 ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES Oratec Interventions, Inc. GEI Class II 1999-10-25
K992760 SELECT-SUTTER MICRO BIPOLAR FORCEPS Select Medizintechnik Hermann Sutter GmbH GEI Class II 1999-10-25
K991970 SCAREASE SHEETS & SCAREASE GEL Pillar Surgical MDA Class I 1999-10-25
K991456 MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 Microwave Medical, Inc. MWY Class II 1999-10-25
K993265 SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 Soring GmbH Medizintechnik GEI Class II 1999-10-22
K992679 SURGEON POWDER-FREE GLOVES, LATEX, STERILE Wear Safe Malaysia Sdn. Bhd. KGO Class I 1999-10-21
K992707 MCL 29 DERMABLATE ER:YAG LASER SYSTEM Aesculap-Meditec North America GEX Class II 1999-10-19
K993148 STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA Stryker Instruments FYA Class II 1999-10-15
K993089 DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER Deroyal Cardiovascular, Inc. FTA Class II 1999-10-14
K992764 ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103 Erbe USA, Inc. GEI Class II 1999-10-14
K992382 SURGITRON RADIOLASE Ellman Intl., Inc. GEI Class II 1999-10-14
K992769 ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- Erbe USA, Inc. GEI Class II 1999-10-14
K993002 CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 Ceram Optec, Inc. GEX Class II 1999-10-14
K991205 ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Allegiance Healthcare Corp. KGO Class I 1999-10-13
K992536 TECHNOSANAT KRYO TSK 2005 Technosanat Innovative Medizintechnik GmbH GEX Class II 1999-10-08
K992907 INTRADUCER Taut, Inc. GBW Class I 1999-10-05
K993055 DEXIDE BIPOLAR FORCEPS II** DEVICE United States Surgical, A Division of Tyco Healthc GEI Class II 1999-10-05
K992460 CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY Starion Instruments GEI Class II 1999-10-05
K992904 MINI-PORT Taut, Inc. GBW Class I 1999-10-05
K990723 DYONICS VARICOSE VEIN ABLATION BLADE Smith & Nephew, Inc. GEI Class II 1999-10-05
K992714 MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 Hysterx, Inc. GEI Class II 1999-10-05
K991667 BROADLINE OR TOWELS Broadline Medical Industries KKX Class II 1999-09-27
K992572 NTERO RF SLEEVE Ntero Surgical, Inc. GEI Class II 1999-09-24
K990816 AVCORE SYSTEM Modular Cutting Systems, Inc. HWE Class I 1999-09-24
K990253 SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 Amba Medical , Ltd. KKX Class II 1999-09-24
K992972 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000 Arthrocare Corp. GEI Class II 1999-09-24
K992159 SURGISIS SLING Cook Biotech, Inc. PAG Class II 1999-09-23
K992282 MICRO-FRANCE LIPOSUCTION CANNULAS Xomed, Inc. QPB Class II 1999-09-23
K992026 SORING GMBH, SONOCA 300 Soring GmbH Medizintechnik BTA Class II 1999-09-23
K992405 AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) Axya Medical, Inc. GAW Class II 1999-09-22
K992374 AURORA HL Premier Laser Systems, Inc. GEX Class II 1999-09-22
K992951 CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. FYA Class II 1999-09-22
K992094 GILTECH PLUS HYDROGEL SKIN DRESSING Giltech Plus, Inc. NAE Class I 1999-09-17
K990362 INSTRUMENT, ULTRASONIC, SCALPEL Ethicon Endo-Surgery, Inc. GEI Class II 1999-09-17
K992814 CYNOSURE ACCOLADE LASER Cynosure, Inc. GEX Class II 1999-09-15
K991529 CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400 Conway Stuart Medical, Inc. GEI Class II 1999-09-14
K992171 COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Allegiance Healthcare Corp. KGO Class I 1999-09-14
K972267 HELICA TC Tenerco, Inc. GEI Class II 1999-09-14
K991218 ORATEC BIPOLAR ABLATION PROBES Oratec Interventions, Inc. GEI Class II 1999-09-13
K992630 THERMALIGHT 2000 Jennifermaxx, Inc. GEX Class II 1999-09-10
K992693 RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 Rita Medical Systems GEI Class II 1999-09-10
K992345 CHRISTOUDIAS SLIM TIP ELECTRODE INSERT Innervision, Inc. GEI Class II 1999-09-10
K991994 TWILIGHT Biolase Technology, Inc. GEX Class II 1999-09-10
K992765 CYNOSURE DIODERM Cynosure, Inc. GEX Class II 1999-09-08
K992013 DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER Continuum Biomedical, Inc. GEX Class II 1999-09-08
K992472 SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM Clinicon Corp. GEX Class II 1999-09-08
K992090 MILLENNIUM GOLD Skytron, Div. the Kmw Group, Inc. FSY Class II 1999-09-08
K992088 BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) GAM Class II 1999-09-03
K992773 CERALAS D10 810NM DIODE LASER Ceram Optec, Inc. GEX Class II 1999-09-01
K992485 MONOPOLAR ELECTRODES AND CABLES Us Endo, Inc. GEI Class II 1999-08-27
K990903 LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) Laserscope GEX Class II 1999-08-27
K990037 NEPTUNE WASTE MANAGEMENT SYSTEM American Immuno Tech FYD Class II 1999-08-24
K991559 MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD Medline Industries, Inc. FXX Class II 1999-08-23
K991312 SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING Library Medical, Inc. MDA Class I 1999-08-20
K992620 BLULAZE Premier Laser Systems, Inc. GEX Class II 1999-08-20
K991830 CAPSULAR SHRINKAGE ELECTRODE Linvatec Corp. JOS Class II 1999-08-20
K992361 PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 Pall Medical FYD Class II 1999-08-20
K992508 TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA Instruments For Medicine and Diagnostics GEX Class II 1999-08-19
K992149 GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405 Geiger Medical Technologies, Inc. GEI Class II 1999-08-19
K983298 BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF Buffalo Filter Co., Inc. FYD Class II 1999-08-16
K982860 UM-L20/ UM-L30 Union Medical Engeneering Co., Ltd. GEX Class II 1999-08-13
K990651 SKIN 2 FORTE SILICONE SHEETING United Hospital Technologies, Inc. MDA Class I 1999-08-13
K992462 OSTEONICS UNIVERSAL DISTAL CEMENT PLUG Howmedica Osteonics Corp. LZN Class II 1999-08-13

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