meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
27
Latest Decision
1999-08-13

Clearances · page 87 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K991960 SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH Stryker Endoscopy GEI Class II 1999-08-13
K991949 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) La Glove (M) Sdn. Bhd. KGO Class I 1999-08-12
K991950 LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) La Glove (M) Sdn. Bhd. KGO Class I 1999-08-12
K991792 CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE Influence, Inc. GEH Class II 1999-08-12
K991669 PMS 750 FINGERSWITCH Wallach Surgical Devices, Inc. GEI Class II 1999-08-12
K992514 CONVERTORS BREATHABLE SURGICAL GOWNS Allegiance Healthcare Corp. FYA Class II 1999-08-12
K983333 BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 Buffalo Filter Co., Inc. FYD Class II 1999-08-11
K983364 BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 Buffalo Filter Co., Inc. FYD Class II 1999-08-11
K991632 FOTONA NOVALIS ER: YAG LASER SYSTEM Fotona D.D. GEX Class II 1999-08-10
K991634 FOTONA NOVALIS R RUBY LASER SYSTEM Fotona D.D. GEX Class II 1999-08-10
K991628 MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA Esc Medical Systems, Inc. GEX Class II 1999-08-09
K992406 VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products GEI Class II 1999-08-06
K992019 LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) La Glove (M) Sdn. Bhd. KGO Class I 1999-08-05
K984029 SILGEL STC-S Nagor , Ltd. MDA Class I 1999-08-05
K992408 ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES Oratec Interventions, Inc. GEI Class II 1999-07-30
K991073 ACIER SUTURES Cardio Thoracic Systems GAQ Class II 1999-07-30
K992146 SCARAID SILICONE GEL SHEETING Biodermis Corp. MDA Class I 1999-07-30
K990345 RABEA DEVICE, MODEL PXXXXXX Signus Medizintechnik GmbH JDK Class II 1999-07-30
K992018 LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) La Glove (M) Sdn. Bhd. KGO Class I 1999-07-30
K992186 QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT Conmedcorp GEI Class II 1999-07-30
K990680 DENTEC LD 15 DIODE LASER Dentek Lasersystems Produktions Ges.M.B.H. GEX Class II 1999-07-30
K991968 CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. Smith & Nephew, Inc. MDA Class I 1999-07-30
K992219 POWDERED LATEX STERILE SURGICAL GLOVES Tg Medical Sdn. Bhd. KGO Class I 1999-07-30
K992218 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 Kirwan Surgical Products, Inc. GEI Class II 1999-07-30
K990914 POLARIS DIODE LASER SYSTEM AND ACCESSORIES Xintec Corporation GEX Class II 1999-07-30
K992061 PULSTAR Lasermed, Inc. GEX Class II 1999-07-30
K991659 UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES Medart Corp. GEX Class II 1999-07-29
K992189 GORE-TEX DUALMESH BIOMATERIAL W. L. Gore & Associates, Inc. FTL Class II 1999-07-29
K991517 CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Galil Medical , Ltd. GEH Class II 1999-07-27
K992020 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) Brightsway Holdings Sdn Bhd KGO Class I 1999-07-26
K992021 BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) Brightsway Holdings Sdn Bhd KGO Class I 1999-07-23
K991588 EMS SWISS ORTHOCLAST (Ems Sa) Electro Medical Systems HSZ Class I 1999-07-21
K991957 CICACARE MANAGEMENT FOR SCARS Smith & Nephew, Inc. MDA Class I 1999-07-20
K990656 CHROMOPHARE D 530 LDR SURGICAL LIGHT Berchtold Holding GmbH FSY Class II 1999-07-20
K991464 DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 Fisma, Inc. GEX Class II 1999-07-20
K991291 STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION Conway Stuart Medical, Inc. GEI Class II 1999-07-14
K991567 SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. Shelhigh, Inc. FTM Class II 1999-07-14
K991992 ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES Allegiance Healthcare Corp. KGO Class I 1999-07-13
K992230 OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP Trimedyne, Inc. GEX Class II 1999-07-12
K990719 EARLOOP FACE MASK Shuenn Bao Shing Corp. FXX Class II 1999-07-12
K984512 NITRILON CORRECT-TOUCH Ct Intl. KGO Class I 1999-07-12
K992083 SCATTERFREE LATERAL EMITTING FIBER Laser Peripherals, LLC GEX Class II 1999-07-12
K991272 CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E Galil Medical , Ltd. GEH Class II 1999-07-12
K991297 UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES Medart Corp. GEX Class II 1999-07-12
K991400 PARIETENE POLYPROPYLENE MESH Sofradim Production FTL Class II 1999-07-12
K992084 CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER Cynosure, Inc. GEX Class II 1999-07-12
K991285 LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE Aesculap-Meditec North America GEX Class II 1999-07-12
K991940 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) Brightway Holdings Sdn. Bhd. KGO Class I 1999-07-12
K991572 ISOLUX SURGICAL HEADLIGHT Isolux America FST Class II 1999-07-08
K991939 BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) Brightway Holdings Sdn. Bhd. KGO Class I 1999-07-01
K991122 CRYO-MONO CRYOGRNIC SYSTEM Influence, Inc. GEH Class II 1999-07-01
K990602 RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES Tecsa Technical Services QPB Class II 1999-07-01
K991234 THE ACME MEDICAL AESTHETIC ND:YAG LASER Acme Medical, Inc. GEX Class II 1999-06-28
K991061 DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING Dermaphylyx, Inc. NAE Class I 1999-06-28
K991891 CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 Ceram Optec, Inc. GEX Class II 1999-06-24
K991859 DEXIDE BIPOLAR FORCEPS II ** DEVICE United States Surgical, A Division of Tyco Healthc GEI Class II 1999-06-23
K991190 DEFLECTABLE ELECTROSURGICAL PROBES Oratec Interventions, Inc. GEI Class II 1999-06-23
K991208 ENDOSCOPIC FIBEROPTIC CABLE Isolux America HBI Class II 1999-06-23
K991814 MULTACHOICE INSTRUMENTS Dexide, Inc. GEI Class II 1999-06-23
K991548 HAL SCOPE HOLDER SYSTEM Noved Medical KKX Class II 1999-06-23
K991191 BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) GAM Class II 1999-06-22
K984240 ENDOPATH ENDOSCOPIC INSTRUMENTS Ethicon Endo-Surgery, Inc. GEI Class II 1999-06-22
K991056 WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM Boston Scientific Corp MQR Class II 1999-06-22
K991637 BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 1999-06-22
K991478 TENDER TOUCH SILICONE GEL PADS Capital Marketing Technologies, Inc. MDA Class I 1999-06-21
K990930 3D ANATOMICAL MESH Santerra Medical Technology, Inc. FTL Class II 1999-06-17
K991855 CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX Conmedcorp GEI Class II 1999-06-15
K990877 HISTOFREEZER DEVICE OraSure Technologies, Inc. GEH Class II 1999-06-14
K990859 DEFLECTABLE TAC ELECTROTHERMAL PROBE Oratec Interventions, Inc. GEI Class II 1999-06-14
K991002 PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP V. Mueller Neuro/Spine FZP Class II 1999-06-11
K991630 ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET Advanced Medical Solutions Group Plc MDA Class I 1999-06-11
K990243 FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES Fotona D.D. GEX Class II 1999-06-09
K991604 EPI-FOAM SILICONE SHEETING Biodermis Corp. MDA Class I 1999-06-09
K991183 DORNIER LASERTRODE FIBER Dornier Surgical Products, Inc. GEX Class II 1999-06-09
K983984 COOLTOUCH V ND:YAG Laser Aesthetics, Inc. GEX Class II 1999-06-07
K984374 SURGISORB Samyang Corp. GAM Class II 1999-06-04
K991167 STERIS SMOKE EVACUATION SYSTEM STERIS Corporation FYD Class II 1999-06-03
K982646 AILEE SUTURES AND AILEE NEEDLES Myco Medical Supplies, Inc. GAL Class II 1999-06-02
K990221 INTRACOIL PERIPHERAL STENT Intratherapeutics, Inc. JCT Class II 1999-06-02
K981353 AVOGEL Avocet Polymer Technologies, Inc. MDA Class I 1999-06-01
K990154 KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM Karl Storz Imaging, Inc. FWF Class I 1999-06-01
K991527 CHROMOPHARE D500, D530, D650 Berchtold Holding GmbH FSY Class II 1999-05-27
K990432 SURGISORB Sutures , Ltd. GAM Class II 1999-05-27
K990902 MODIFICATION OF MLT R694 RUBY LASER SYSTEM Medical Laser Technologies , Ltd. GEX Class II 1999-05-27
K991317 POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Safeskin Corp. KGO Class I 1999-05-21
K984395 SURGEON'S GLOVES Sri Anusham Rubber Industries Pvt., Ltd. KGO Class I 1999-05-21
K990710 BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES Barriermed Glove Co. KGO Class I 1999-05-20
K990586 CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES Conmedcorp GEI Class II 1999-05-17
K990474 ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES Oratec Interventions, Inc. GEI Class II 1999-05-17
K991030 PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES Ethicon Endo-Surgery, Inc. GDW Class II 1999-05-17
K990568 SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 Synergetics, Inc. GEX Class II 1999-05-14
K991258 NOVUS VERDI DELIVERY SYSTEMS Lumenis, Inc. GEX Class II 1999-05-13
K984486 PULSEMASTER DENTAL LASER SYSTEM American Dental Technologies, Inc. GEX Class II 1999-05-13
K990748 EDGE SYSTEMS STERILE TUBING Edge Systems Corp. GEX Class II 1999-05-04
K983982 SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES Maxxim Medical KGO Class I 1999-05-04
K982853 SILK SUTURE Davis & Geck, Inc. GAP Class II 1999-04-30
K991223 ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC Aesculap, Inc. GAL Class II 1999-04-30
K990452 ORLIGHT 2000 SURGICAL LASER SYSTEM Ybeam Technologies, Inc. GEX Class II 1999-04-29
K984151 STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP Mill Pond, Inc. GAQ Class II 1999-04-28
K990947 MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY Lumenis, Inc. GEX Class II 1999-04-27

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