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
1995-02-24

Clearances · page 103 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945648 ACCU-BEAM C02 LASER HANDPIECE Tti Medical GEX Class II 1995-02-24
K945178 TOUCH FOCUS 200MM DEFOCUSING HANDPIECE Plc Medical Systems, Inc. GEX Class II 1995-02-24
K950574 NEEDLE/CANNULA Tri-Med Specialties, Inc. LRO Class II 1995-02-24
K950505 50MM HANDPIECE Plc Medical Systems, Inc. GEX Class II 1995-02-24
K941487 INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS Instent, Inc. ESW Class II 1995-02-23
K942828 MAKAR FULL AND HALF FACE SHIELD Instrument Makar, Inc. LYU Class I 1995-02-23
K950347 LEVEEN NEEDLE ELECTRODE(TM) Radiotherapeutics Corp. GEI Class II 1995-02-23
K933952 PHOTOTHERAPEUTIX MODEL 800B Avex Industries , Ltd. FTC Class II 1995-02-21
K950403 SURGICAL SAW BLADES Transidyne General Corp. GFA Class I 1995-02-21
K933954 PHOTOTHERAPEUTIX MODEL 2400B Avex Industries , Ltd. FTC Class II 1995-02-21
K933953 PHOTOTHERAPEUTIX MODEL 1650B Avex Industries , Ltd. FTC Class II 1995-02-21
K942495 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM Atos Medical AB KAM Class I 1995-02-21
K935526 PHOTOTHERAPEUTIX MODEL 1600B Avex Industries , Ltd. FTC Class II 1995-02-17
K935524 PHOTOTHERAPEUTIX MODEL 3200A Avex Industries , Ltd. FTC Class II 1995-02-17
K945163 ECHOCARDIOGRAPHY Tri W-G, Inc. LGX Class I 1995-02-17
K945694 NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS American Hydro-Surgical Instruments, Inc. GEI Class II 1995-02-17
K945738 VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE Visitec Co. HMT Class II 1995-02-14
K945158 MICRO-TOUCH LP LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1995-02-13
K943674 NEUTRALON LP BROWN LATEX SURGICAL GLOVES Maxxim Medical KGO Class I 1995-02-13
K945157 MAXXUS LP ORTHOPAEDIC LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1995-02-13
K945899 GORE-TEX(R) CURVED SURGICALMEMBRANE W. L. Gore & Associates, Inc. FTL Class II 1995-02-13
K945167 DJ MEDICAL PNEUMATIC TOURNIQUET Dj Medical, Inc. KCY Class I 1995-02-13
K950188 VALLEYLAB COATED ELECTRODES Valleylab, Inc. GEI Class II 1995-02-10
K945531 BLADE ELECTRODE E & M Engineering, Inc. GEI Class II 1995-02-10
K946336 MEGABEAM FIBER OPTIC DELIVERY SYSTEM Hogan & Hartson GEX Class II 1995-02-10
K946024 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS 3M Healthcare KKX Class II 1995-02-08
K945998 CHIN IMPLANT STYLE I King & Spalding FWP Class II 1995-02-07
K950086 PEDIA PALS, INCORPORATED Pedia Pals, Inc. EPY Class I 1995-02-07
K931286 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1995-02-06
K943566 ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1995-02-03
K943393 CIVCO PROBE BOOT/CORD COVER CIVCO Medical Instruments Co., Inc. KKX Class II 1995-02-02
K946025 3M X-LARGE SHEET #7979/ #7979NS 3M Healthcare KKX Class II 1995-02-02
K945027 TROCHANTER MESH Acu Med, Inc. EZX Class II 1995-02-01
K944946 CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER U.S. Medical Products, Inc. HWE Class I 1995-02-01
K945317 NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES American Hydro-Surgical Instruments, Inc. GEI Class II 1995-02-01
K945995 BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS Ximed/Prosure/Injectx GEI Class II 1995-01-31
K945759 HIGH TEMPERATURE CAUTERY 5 LOOP Aaron Medical Industries GEI Class II 1995-01-30
K945760 HIGH TEMPERATURE CAUTERY Aaron Medical Industries GEI Class II 1995-01-30
K945757 HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE Aaron Medical Industries GEI Class II 1995-01-30
K945765 HIGH TEMPERATURE CAUTERY Aaron Medical Industries GEI Class II 1995-01-30
K945492 HIGH TEMPERATURE CAUTERY Aaron Medical Industries GEI Class II 1995-01-30
K944928 PY30, PY60, PY80 Huttinger Medizintechnik GmbH & CO KG GEX Class II 1995-01-27
K943988 IMPLANTECH NASAL LABIAL IMPLANT Implantech Associates, Inc. LZK Class II 1995-01-27
K945189 CONSENSUS HIP SYSTEM -- CALCAR PLANER U.S. Medical Products, Inc. HWE Class I 1995-01-27
K945208 CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER U.S. Medical Products, Inc. HWE Class I 1995-01-27
K945186 CONSENUS HIP SYSTEM -- ACETABULAR REAMER U.S. Medical Products, Inc. HWE Class I 1995-01-27
K945231 SELF-LATCHING CLIP Surgical System, Inc. FZP Class II 1995-01-27
K945888 MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM Luxar Corp. GEX Class II 1995-01-27
K945701 SURGILENE(R) SUTURES Davis & Geck, Inc. GAW Class II 1995-01-24
K946162 3M(TM) SURGICAL SLIPPER, 9660 SERIES Wahl Clipper Corp. LWK Class I 1995-01-24
K945831 DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT Micromed Development Corp. LRO Class II 1995-01-20
K945181 GENERA 100 SURGICAL SYSTEM Xintec Corporation GEX Class II 1995-01-20
K942299 ENDOCARE CRYOTHERAPY SYSTEM Cytocare, Inc. GEH Class II 1995-01-19
K944399 MEDI-PUMP Thomas Industries BTA Class II 1995-01-18
K945560 UROTEK LASER CATHETER Energy Life Systems Corp. GEX Class II 1995-01-18
K922979 STERILE EXTRA PROTECION SURGEON'S GLOVES Ansell Malaysia Sdn Bhd KGO Class I 1995-01-18
K945126 ECLIPSE 3200 Cardiogenes GEX Class II 1995-01-18
K944110 VICRYL RAPIDE SUTURE ETHICON, Inc. GAM Class II 1995-01-18
K945833 ELASTYREN(R) SURGICAL GLOVES Eci Medical Technologies, Inc. KGO Class I 1995-01-17
K945154 BA-CPAS Nobelpharma USA, Inc. FZE Class II 1995-01-13
K943928 APILUS ELECTROPIL Dectro Intl., Inc. KCW Class I 1995-01-12
K945192 HAIR REMOVAL SYSTEM L.P. Systems Corp. KCW Class I 1995-01-12
K946173 STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc. GAQ Class II 1995-01-09
K944704 OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES Xintec Corporation GEX Class II 1995-01-06
K944965 OPTILITE VI FIBEROPTIC ACCESSORIES Xintec Corporation GEX Class II 1995-01-06
K946002 ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA Origin Medsystems, Inc. GEX Class II 1995-01-05
K941096 ELECTRIC VACUM PUMP Impact Instrumentation, Inc. BTA Class II 1995-01-05
K945201 COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT Cook, Inc. ESW Class II 1995-01-04
K943034 OREX SHOE COVERS Thantex Specialties, Inc. FXP Class I 1995-01-02
K942294 ASEP PLUS SURGICAL DRAPES Angelica Uniform KKX Class II 1995-01-02
K945333 KITTNER DISSECTOR Lorrex Health Products GDY Class I 1994-12-28
K945553 ROUND STICK SPONGES, FLAT STICK SPONGES Lorrex Health Products GDY Class I 1994-12-28
K945606 TRIANGULAR SPONGES Lorrex Health Products GDY Class I 1994-12-28
K945866 CYLINDRICAL SPONGE Lorrex Health Products GDY Class I 1994-12-28
K945335 CHERRY DISSECTOR Lorrex Health Products GDY Class I 1994-12-28
K944758 SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT Cardiogenes GEX Class II 1994-12-27
K945481 SHAVE PREP KIT Harding Industries, Inc. LRO Class II 1994-12-23
K944879 GAUZE SPONGES Clinical Resources, Inc. GDY Class I 1994-12-23
K945929 S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP Sscor BTA Class II 1994-12-22
K944681 LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES Birtcher Medical Systems, Inc. GEI Class II 1994-12-22
K944749 OPTICA 100 SUPERPULSED LASER SYSTEM Xintec Corporation GEX Class II 1994-12-22
K943055 ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES Megadyne Medical Products, Inc. GEI Class II 1994-12-21
K944012 ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR Aspen Laboratories, Inc. GEI Class II 1994-12-21
K945975 EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS Everest Medical Corp. GEI Class II 1994-12-21
K944138 INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL Baxter Healthcare Corp FYA Class II 1994-12-20
K942228 OREX O.R. TOWEL Thantex Specialties, Inc. KKX Class II 1994-12-20
K940767 OREX (12X12 X-RAY DETECTABLE) Thantex Specialties, Inc. GDY Class I 1994-12-19
K940764 OREX Thantex Specialties, Inc. GDY Class I 1994-12-19
K942935 ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE Reliant Technologies, Inc. GEX Class II 1994-12-19
K940766 OREX (18X18 X-RAY DETECTABLE) Thantex Specialties, Inc. GDY Class I 1994-12-19
K941838 MULTIPLE CO2 LAERS Mattioli Engineering, Srl GEX Class II 1994-12-15
K945563 CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) Energy Life Systems Corp. GEX Class II 1994-12-15
K944880 BODILY FLUID DISPOSAL KIT Clinical Resources, Inc. FXX Class II 1994-12-15
K944221 VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED Cryosurgery, Inc. GEH Class II 1994-12-15
K944474 OPTILITE V FIBEROPTIC ACCESSORIES Xintec Corporation GEX Class II 1994-12-15
K940198 L-CATH CONNECTOR ASSEMBLY Luther Medical Products, Inc. GCD Class I 1994-12-15
K943589 STRYKER TOTAL PERFORMANCE SYSTEM Stryker Corp. HWE Class I 1994-12-15
K942911 GLYCAR TISSUE REPAIR PATCH Glycar, Inc. FTL Class II 1994-12-14
K945898 ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES Megadyne Medical Products, Inc. GEI Class II 1994-12-13
K943045 UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED Reliant Technologies, Inc. GEX Class II 1994-12-13

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