meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
44
Latest Decision
1994-03-30

Clearances · page 108 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K940909 ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE Debusk Technology Corp. GEI Class II 1994-03-30
K935621 CUSTOM ENT PACKS Associated Medical LRP Class I 1994-03-30
K930297 FUJINON VIDEO LAPAROSCOPE, MODIFIED Fujinon, Inc. FWF Class I 1994-03-29
K932694 KAPPLER PRO/VENT PROCEDURE GOWN Kappler, Inc. FYA Class II 1994-03-29
K932738 KAPPLER PRO/VENT BOOT Kappler, Inc. FXP Class I 1994-03-29
K934194 BARRIER LASER PLUS FACE MASK Johnson & Johnson Medical, Inc. FXX Class II 1994-03-28
K934969 DUALGARD FACE SHIELD White Knight Healthcare FXX Class II 1994-03-28
K931215 HAND-TROL S Aspen Labs DWG Class II 1994-03-28
K934744 MIDMARK MAGNUM GENERAL SURGICAL TABLE Midmark Corp. GDC Class I 1994-03-28
K933600 NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS Navarre Biomedical , Ltd. GBX Class I 1994-03-28
K935222 STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES Stryker Endoscopy GEI Class II 1994-03-25
K940266 BEI MEDICAL SYSTEMS' SMOKE EVACUATOR Bei Medical Systems Co., Inc. FYD Class II 1994-03-24
K933516 ACU-E PUNCH Acuderm, Inc. LRY Class I 1994-03-24
K934486 COOL LASER OPTICS (CLO) UNIT Cyruschess GEX Class II 1994-03-24
K935356 CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES Amsco American Sterilizer Co. FWW Class I 1994-03-23
K933994 ARTHREX TOURNIQUET FOR LEG HOLDER Arthrex, Inc. KCY Class I 1994-03-23
K926216 BONE CEMENT RESTRICTOR Biodynamic Technologies, Inc. JDK Class II 1994-03-22
K940535 AUTO LUBE SYSTEM The Anspach Effort, Inc. GEY Class I 1994-03-21
K935237 STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Stryker Endoscopy GEI Class II 1994-03-21
K932062 OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR Alcon Laboratories GEX Class II 1994-03-18
K940069 DRESSING CHANGE KIT Mason-Keller Corp. FYA Class II 1994-03-18
K940672 CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL Philips Lighting Co. LEJ Class II 1994-03-18
K935305 CYNOSURE PHOTOTOME SURGICAL DIODE LASER Cynosure, Inc. GEX Class II 1994-03-18
K934688 STERILE DESIGN Sterile Design, Inc. LRO Class II 1994-03-16
K933595 BUR, SURGICAL, GENERAL & PLASTIC SURGERY Omega Surgical Instruments, Inc. GFA Class I 1994-03-16
K931762 CANDELA SPTL PULSED DYE LASERS Candela Laser Corp. GEX Class II 1994-03-15
K940684 SURGICAL INSTRUMENT, DISPOSABLE Her-Mar, Inc. MDM Class I 1994-03-14
K925178 PEGASUS Premier Laser Systems, Inc. GEX Class II 1994-03-14
K934790 SEPP ADHESIVE REMOVER Medi-Flex Hospital Products, Inc. KOX Class I 1994-03-11
K940646 ORTHOPEDIC TRAY PRODUCT LINE Cushindu LRP Class I 1994-03-11
K924057 DISPOSIBLE ELECTRO COAGULATION PROBE Endoscopic Technologies, Inc. GEI Class II 1994-03-11
K930243 FLEXIBLE EXTENDER Beacon Laboratories, Inc. GEI Class II 1994-03-11
K935517 SNAP STERNUM SAW Surgiquip, Inc. HAB Class I 1994-03-10
K936186 AESCULAP SKIN GRAFT MESHER Aesculap, Inc. FZW Class I 1994-03-10
K936048 LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) Cogent Light Technologies, Inc. FST Class II 1994-03-10
K933002 ERBOTOM ICC 350 Erbe USA, Inc. GEI Class II 1994-03-09
K932817 HM-880 I Hill-Med, Inc. GEI Class II 1994-03-09
K926543 SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 60 Sharplan Lasers, Inc. GEX Class II 1994-03-09
K934842 TECNOL SPLASHGUARD Tecnol Medical Products, Inc. LYU Class I 1994-03-09
K924258 MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST Ceram Optec, Inc. GEX Class II 1994-03-09
K934828 CONMED UNIVERSAL PLUS Conmedcorp GEI Class II 1994-03-07
K935874 COOK COAGULATOR PROBE Cook Urological, Inc. GEI Class II 1994-03-07
K940333 EYE PAD Certified Safety Mfg., Inc. HMP Class I 1994-03-07
K935572 SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT Solarc Systems, Inc. FTC Class II 1994-03-07
K933265 ACU-DISPO-CE(TM) Acuderm, Inc. MDM Class I 1994-03-07
K934883 3D VIDEO SYSTEM Richard Wolf Medical Instruments Corp. FWG Class I 1994-03-07
K935660 MEDICOTEX(TRADEMARK APPLICATION PENDING) Itochu International, Inc. FYA Class II 1994-03-07
K940444 GENERAL SURGERY TRAY Cush Medical Products LRP Class I 1994-03-07
K935227 MAXXUS ORTHOPAEDIC LATEX SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1994-03-07
K935439 SNJ SMOKE EVACUATION SUCTION WAND Lca, Inc. FYD Class II 1994-03-07
K936226 SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET Meadox Medicals, Div. Boston Scientific Corp. KDC Class I 1994-03-07
K934784 ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE ETHICON, Inc. GEI Class II 1994-03-04
K931916 SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER Surgimetrics International, Ltd. GAT Class II 1994-03-03
K931913 SUTURE NON-ABSORBABLE SILK Surgimetrics International, Ltd. GAP Class II 1994-03-03
K931918 CATGUT SUTURE PLAIN Surgimetrics International, Ltd. GAL Class II 1994-03-03
K935743 INSTRUMENT TRAY Cush Medical Products LRO Class II 1994-03-03
K931915 STAINLESS STEEL SUTURE Surgimetrics International, Ltd. GAQ Class II 1994-03-03
K931917 SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE Surgimetrics International, Ltd. GAW Class II 1994-03-03
K931919 CATGUT SUTURE CHROMIC Surgimetrics International, Ltd. GAL Class II 1994-03-03
K933140 RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM Laser Photonics, Inc. GEX Class II 1994-03-02
K925124 TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST Trimedyne, Inc. GEX Class II 1994-03-01
K935775 LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS Heraeus Surgical, Inc. GEX Class II 1994-03-01
K925414 LATERALASE CATHETER Trimedyne, Inc. GEX Class II 1994-03-01
K931264 INFINITECH OTOPROBE Infinitech, Inc. GEX Class II 1994-03-01
K922497 OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM Trimedyne, Inc. GEX Class II 1994-03-01
K932730 EXCEL'S EST-30 HO:YAG LASER SYSTEM Excel Tech. , Ltd. GEX Class II 1994-03-01
K933525 DIOMED 25 25W SURGICAL DIODE LASER Dio-Med Corp. GEX Class II 1994-03-01
K936117 CENTRAL LINE TRAY Cush Medical Products LRO Class II 1994-03-01
K922496 TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST Trimedyne, Inc. GEX Class II 1994-03-01
K935091 ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE Conmedcorp GEI Class II 1994-02-28
K930030 SUCTION TUBES: HOUSE, BARON Thomasville Medical Assoc. JCX Class II 1994-02-25
K935686 DRESSING CHANGE TRAY Cush Medical Products LRO Class II 1994-02-25
K934281 PHX TECHNOLOGIES CORP.,HOOK ELECTRODE, 5MM Phx Technologies Corp. GEI Class II 1994-02-25
K932818 HM-880 Hill-Med, Inc. GEI Class II 1994-02-25
K940025 MANAN BONE MARROW HARVEST NEEDLES Manan Medical Products, Inc. GAA Class I 1994-02-25
K933880 SL SERIES SURGICAL LASER SYSTEMS Laserscope GEX Class II 1994-02-25
K940024 MANAN GENERAL PURPOSE INTRODUCER NEEDLE Manan Medical Products, Inc. GAA Class I 1994-02-25
K935840 TL 20W/12/RS & TL 40W/12/RS Philips Lighting Co. FTC Class II 1994-02-24
K935869 DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1994-02-24
K935391 SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK 3M Health Care, Sarns GFA Class I 1994-02-24
K940208 AESCULAP ACCU-DERMATOME Aesculap, Inc. GFD Class I 1994-02-24
K933510 ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER Sherwood Medical Co. GBW Class I 1994-02-24
K923605 MODIFIED SHARPLAN 1041 Sharplan Lasers, Inc. GEX Class II 1994-02-23
K933157 ERBOTOM ICC 200 Erbe USA, Inc. GEI Class II 1994-02-23
K933728 JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 J. Jamner Surgical Instruments, Inc. GEI Class II 1994-02-23
K935858 MILL-ROSE PERCUTANEOUS PROCEDURAL KIT Mill-Rose Laboratory LRO Class II 1994-02-22
K932483 SUNDASH Sun Ind., Inc. LEJ Class II 1994-02-22
K934603 SURGICAL SAW BLADES American Medical Specialties, Inc. GFA Class I 1994-02-22
K935538 BAUER TEMNO COAXIAL NEEDLE Bauer Medical, Inc. GDF Class I 1994-02-22
K935740 IRRIGATION TRAY Cush Medical Products LRO Class II 1994-02-22
K931734 INTERMEDICS ORTHOPEDICS DRILL BITS Intermedics Orthopedics HWE Class I 1994-02-22
K933137 ACU-SUTURE KIT Acuderm, Inc. LRO Class II 1994-02-22
K931675 MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS Medline Industries, Inc. FTD Class II 1994-02-22
K935105 REFLEX ESP WITH FINGER SWITCHES Richard-Allan Medical GEI Class II 1994-02-22
K930615 AUTOVAC CLOSED WOUND SUCTION SYSTEM Boehringer Laboratories GCY Class I 1994-02-22
K932654 ELECTROSURGIAL INSTRUMENTS Medline Industries, Inc. GEI Class II 1994-02-22
K932230 CRYSTAL VISION AND ACCESSORIES I.C Medical, Inc. FYD Class II 1994-02-18
K935870 DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1994-02-18
K930270 PATIENT PREOPERATIVE PREP TRAY, SINGLE USE Professional Medical Products, Inc. LRO Class II 1994-02-17
K931348 BATTERY PACK #1005NC Portable Power Systems, Inc. BTA Class II 1994-02-17

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