meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
48
Latest Decision
1985-03-20

Clearances · page 145 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850099 VISOPROTECT: OCCULAR SHIELD Rockway Enterprises, Inc. HMP Class I 1985-03-20
K850005 VISOPROTECT OCCULAR SHIELD M.S.G. Health Systems, Inc. HMP Class I 1985-03-20
K850037 CLOSED WOUND DRAIN Consolidated Medical Equipment, Inc. GCY Class I 1985-03-19
K844889 MENSINK-GOOSEN CATHETER Goosen Enterprises, Inc. GBP Class I 1985-03-18
K850389 MULTIPLE OUTLET MANIFOLD The Anspach Effort, Inc. GEY Class I 1985-03-18
K850288 HEPATIC PARENCHYMAL SUCTION DISSECTOR Beecher Medical Diagnostic Instrumentation GDI Class I 1985-03-18
K844922 PERIMETER THORACIC CATHETER Perimeter Medical, Inc. GBX Class I 1985-03-18
K844921 PERIMETER CLOSED WOUND RESEVOIR Perimeter Medical, Inc. GCY Class I 1985-03-18
K850527 ARTHROSCOPY SUCTION BIOPSY PUNCH T. Korossurgical Instruments Corp. HTZ Class I 1985-03-14
K850423 CONCEPT SUCTION SLEEVE Concept, Inc. HTZ Class I 1985-03-14
K843200 SITE STRIP E-Med Corp. NAD Class I 1985-03-12
K845038 BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT Ranfac, Corp. GDF Class I 1985-03-11
K844162 EZ 505 Aeg Power Tool Corp. KIJ Class I 1985-03-11
K844163 EZ 502 Aeg Power Tool Corp. KIJ Class I 1985-03-11
K850497 MICRO-AIRE GENERIC BURS & DRILLS Micro-Aire Surgical Instruments, Inc. GFF Class I 1985-03-01
K850483 MICRO-AIRE STERNUM SAW REPLACEMENT BLADES Micro-Aire Surgical Instruments, Inc. DWH Class I 1985-03-01
K850660 SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY Suntech USA, Inc. FTC Class II 1985-03-01
K844246 NETHERY EXTREMITY FREEZING UNIT Howard J. Nethery & Assoc. GEH Class II 1985-02-28
K850493 SUNSHOWER MODEL HU-01-12L Sunthetic Engineering, Inc. FTC Class II 1985-02-28
K850297 ELECTROSURGICAL PENCIL HOLDER 720 Birtcher Corp. GEI Class II 1985-02-28
K850129 MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN Consolidated Medical Equipment, Inc. GEI Class II 1985-02-28
K844087 XANAR MODEL XSE-300 SMOKE EVACULATER Xanar, Inc. FYD Class II 1985-02-27
K850325 STERILE SUTURE REMOVAL KIT Excel Health Care Products KDD Class I 1985-02-26
K843974 VARIABLE TEMPERATURE CAUTERY DEVICE National Patent Development Corp. GEI Class II 1985-02-26
K844960 CANAL WALL PROSTHESIS Richards Medical Co., Inc. FZD Class II 1985-02-26
K850326 STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH Excel Health Care Products KKX Class II 1985-02-26
K845001 MARTANIQUE 6-TUBE HOME SOLARIUM Bainbridge Trading Co., Ltd. FTC Class II 1985-02-21
K844372 HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE Consolidated Medical Equipment, Inc. GEI Class II 1985-02-21
K844565 BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) Clinical Technology Corp. GEI Class II 1985-02-21
K850122 SONI-LOK SCOPE STABILIZER Med Surg Designs, Inc. FXR Class I 1985-02-21
K850199 POLY-LINED TOWEL/DRAPE LINE Excel Health Care Products KKX Class II 1985-02-21
K850150 ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED Gainor Medical FMK Class II 1985-02-21
K850177 MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) Matrix Medica, Inc. FYA Class II 1985-02-21
K850204 PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP Philips Int'L B.V. FTC Class II 1985-02-21
K850206 PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP Philips Int'L B.V. FTC Class II 1985-02-21
K850203 PHILIPS UV-A SOLARIUM TYPE HP 3016-SUNLAMP Philips Int'L B.V. FTC Class II 1985-02-21
K850205 PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP Philips Int'L B.V. FTC Class II 1985-02-21
K844371 HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE Consolidated Medical Equipment, Inc. GEI Class II 1985-02-20
K844428 RADIOTOM 804 Siemens Medical Solutions USA, Inc. GEI Class II 1985-02-20
K844403 MODEL FORCE 2 ELECTROSURGICAL GENERATOR Valleylab, Inc. GEI Class II 1985-02-20
K850247 PERITONEAL DIALYSIS COIL CATHETER Sil-Med Corp. FXX Class II 1985-02-14
K845023 STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 Storz Instrument Co. LGX Class I 1985-01-28
K844200 K.M. PRODUCTS ASPIRATOR Km Products BTA Class II 1985-01-25
K844228 PDS POLYDIOXANONE MESH ETHICON, Inc. FTM Class II 1985-01-24
K844837 VISISTAT SKIN STAPLING DEVICE Edward Weck, Inc. GDT Class I 1985-01-23
K844838 SKIN STAT II SKIN STAPLING MEDICAL DEVICE Edward Weck, Inc. GDT Class I 1985-01-23
K844062 FORCEPS & HAMOSTATS I M, Inc. GEN Class I 1985-01-18
K844759 SURGICAL SCALPEL BLADES & DISPOSABLES Cross Country Paper Products Corp. GES Class I 1985-01-18
K844786 NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR Durawear FYC Class II 1985-01-18
K844460 ND. YAG LASER RECTAL PATHOLOGY Endo Lase, Inc. LNK Class II 1985-01-16
K844625 BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY Bipore, Inc. KOZ Class I 1985-01-16
K844459 ND:YAG LASER UROLOGICAL SURGERY Endo Lase, Inc. LNK Class II 1985-01-16
K845028 MARTANIQUE 7-TUBE RUVA HOME SOLARIUM Bainbridge Trading Co., Ltd. FTC Class II 1985-01-14
K844865 SECURLINE SURGICAL SKIN MARKER 1000 Precision Dynamics Corp. FZZ Class I 1985-01-14
K850042 SOLAR TAN - SOLARIA IV Sola-Tan Intl. FTC Class II 1985-01-14
K844802 SURGICAL DRAPES Procter & Gamble Mfg. Co. KKX Class II 1985-01-14
K843724 I.V. START KIT & OBSTETRICAL KIT E.M. Adams KKX Class II 1985-01-10
K844613 GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR Packaging Technologies, Inc. FSM Class I 1985-01-10
K844704 CAPS (O.R. NURSE, SURGICAL) Medicon, Inc. FYF Class I 1985-01-10
K844703 GOWNS, SURGICAL Medicon, Inc. FYA Class II 1985-01-10
K844705 SHOE COVERS Medicon, Inc. FXP Class I 1985-01-10
K844870 SUNTAN CONNECTIONS BAHAMA SUN-BOOTH Suntan Connection FTC Class II 1985-01-09
K844411 SCRUB MATE DRY STERILE SCRUB BRUSH American Sterilizer Co. GEC Class I 1984-12-17
K833085 STAPLE REMOVER SR300P Prosper, Inc. GDT Class I 1984-12-14
K844600 SLIP JOINT PLIERS Med-Tool, Inc. HTC Class I 1984-12-14
K843498 BIPOLAR SUCTION ELECTRODE Eder Instrument Co, Inc. GET Class I 1984-12-14
K844004 ESCHMANN TDB50 BIPOLAR COAGULATION Storz Instrument Co. GEI Class II 1984-12-12
K843295 MED. DYNAMICS HIGH RESOLUTION SOLID ST Medline Industries, Inc. KQM Class I 1984-12-12
K843806 VIS-1000 VIDEO SYSTEM Vistek Corp. KQM Class I 1984-12-12
K844652 C.A.S.E. CONTAINER General Medical Co. FSM Class I 1984-12-12
K843294 MED. DYNAMICS SATICAN VIDEO CAMERA 5410 Medline Industries, Inc. KQM Class I 1984-12-12
K841459 REPLACE-A-TIP ADJUST. LOW TEMP.- Suncoast Medical Manufacturers, Inc. GEI Class II 1984-12-07
K843518 MINUTEMAN C02 MICROSURG LASER PODIATRY American Surgical Laser, Inc. GEY Class I 1984-12-07
K842959 MC-4000 CONSOLE & PROBES Cryomedics, Inc. GEH Class II 1984-12-07
K841603 ADJUST-A-TEMP MICRO Suncoast Medical Manufacturers, Inc. GEI Class II 1984-12-07
K843517 MINUTEMAN CO2 MICROSURG LASER DERMATOL- American Surgical Laser, Inc. GEY Class I 1984-12-07
K843519 MINUTEMAN CO2 MICROSURG LASER GEN SURG American Surgical Laser, Inc. GEY Class I 1984-12-07
K841509 REPLACE-A-TIP ADJUSTABLE HIGH TEMP. Suncoast Medical Manufacturers, Inc. GEI Class II 1984-12-07
K841604 ADJUST-A-TEMP HIGH TEMPERATURE Suncoast Medical Manufacturers, Inc. GEI Class II 1984-12-07
K844465 PMS DRAPE PACK Professional Medical Services KKX Class II 1984-12-05
K843627 VENESECTION TRAY, ADULT 6050 Pro-Lab, Inc. FSM Class I 1984-12-04
K843056 ELASTIC BANDAGE Sterile Medical Systems GAX Class I 1984-12-04
K844017 MICROTENS 7757 T.E.N.S. STIMULATOR Rabar, Inc. GFJ Class I 1984-11-30
K844094 PRUITT IRRIGATION AND OCCLUSION CATHETER Bionomy, Inc. GBX Class I 1984-11-29
K842884 SURGEON'S GLOVES Travenol Laboratories, S.A. KGO Class I 1984-11-29
K844131 NUCLEOTOME Medical Instrument Development Laboratories, Inc. HSZ Class I 1984-11-29
K844095 WET DRESSING WATER-STERILE Absorbent Cotton Co., Inc. NAD Class I 1984-11-27
K843468 PHARMA-PLAST SUCTION SET TYPE YANKAUER Zimmar Consulting , Ltd. GEA Class I 1984-11-23
K844323 KONAN CLINIC MICROSCOPE CLM-100-150 Keeler Instruments, Inc. HRM Class I 1984-11-21
K844236 PRISTINE Medical Dimensions KGO Class I 1984-11-21
K844146 TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW Med-Tool, Inc. HTC Class I 1984-11-20
K844145 GENERAL SURGICAL FILES Med-Tool, Inc. GEO Class I 1984-11-20
K844110 XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001 Pelco, Inc. PYE Class I 1984-11-19
K844286 FLASH GUARD PLASTIC VERSION Sparco, Inc. FSM Class I 1984-11-19
K843644 STORZ ASPIRATION MACHINE SAM 5000 Storz Instrument Co. BTA Class II 1984-11-16
K843636 FOAM CARE ONE STEP PREP Ballard Medical Products GEC Class I 1984-11-16
K844225 LINK ACETABULAR MESH Waldemar Link GmbH & Co. KG FTM Class II 1984-11-14
K844001 LANCE BLADES & SCALPELS Perry, Div. GES Class I 1984-11-08
K843902 SOLAR-GOLD UV-A BY EOS Eos-Werke, Gunther GmbH FTC Class II 1984-11-08
K844002 HU-FRIEDY IMS CASSETTE SYSTEM Hu-Friedy Mfg. Co., Inc. FSM Class I 1984-11-08

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