meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
36
Latest Decision
1997-06-13

Clearances · page 94 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971805 ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE Aaron Medical Industries GEI Class II 1997-06-13
K970934 CB ERBIUM/2.94(TM) ER:YAG LASER Continuum Biomedical, Inc. GEX Class II 1997-06-11
K971674 VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST Aaron Medical Industries GEI Class II 1997-06-11
K971061 OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY Opportunity, Inc. LRO Class II 1997-06-11
K971468 SCAR HEAL Specialty Systems, Inc. MDA Class I 1997-06-10
K971062 OPPORTUNITY INC. GENERAL PURPOSE TRAY Opportunity, Inc. LRO Class II 1997-06-09
K971107 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 Alexander Mfg. Co. BTA Class II 1997-06-05
K965180 STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) Myriad Lase, Inc. GEX Class II 1997-06-05
K971539 NOVATIP FAMILY OF LASER HANDPIECE TIPS Xanova Corp. GEX Class II 1997-06-03
K970804 TRU-PULSE CO2 SURGICAL LASER Tissue Technologies, Inc. GEX Class II 1997-06-03
K970957 OSTEONICS RESTORATION ACETABULAR RING Osteonics Corp. JDJ Class II 1997-06-03
K970243 CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR Cynosure, Inc. GEX Class II 1997-06-03
K971036 ODONTIT AUTOGENOUS BONE COLLECTION DEVICE Interpore Intl. GCY Class I 1997-06-03
K971114 BIOACCESS MARROW HARVEST SYSTEM Bioaccess, Inc. GDM Class I 1997-06-03
K971201 AUTO SUTURE* ILM** KIT United States Surgical, A Division of Tyco Healthc FZP Class II 1997-06-03
K971216 FRIGIDERM FRIGISPRAY Dermatologic Lab & Supply, Inc. GEH Class II 1997-05-29
K971544 SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) Synthes (Usa) HWE Class I 1997-05-28
K970797 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES Olympus America, Inc. GEI Class II 1997-05-28
K964252 ORTHOCHUCK Buckman Co., Inc. GEY Class I 1997-05-27
K970814 NON-STERILE ISOLATION GOWN American Seal Co. FYC Class II 1997-05-27
K970554 CONVERTORS SMS DRAPES Allegiance Healthcare Corp. KKX Class II 1997-05-27
K971548 AMBUVAC Kinetic Concepts, Inc. OMP Class II 1997-05-22
K970993 DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE Deroyal Industries, Inc. GEI Class II 1997-05-22
K971341 KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR Kirwan Surgical Products, Inc. GEI Class II 1997-05-22
K970948 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES Laserscope GEX Class II 1997-05-21
K964329 UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) Richard Wolf Medical Instruments Corp. GEI Class II 1997-05-21
K971390 QUANTUM 3080SP SURGICAL TABLE STERIS Corporation GDC Class I 1997-05-15
K970667 NUVO-LASE 660 LASER SYSTEM American Laser Medical GEX Class II 1997-05-13
K971208 MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS Medline Industries, Inc. GAM Class II 1997-05-13
K963340 MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE Continuum Biomedical, Inc. GEX Class II 1997-05-12
K970702 SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. MDA Class I 1997-05-12
K971048 PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT Bio-Vascular, Inc. FTM Class II 1997-05-09
K970779 OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS Osteonics Corp. LZN Class II 1997-05-09
K970496 HEARTPORT MAZE SYSTEM: CRYOPROBE SET Heartport, Inc. OCL Class II 1997-05-09
K970757 FOTONA SKINSCAN Medical Laser Solutions GEX Class II 1997-05-09
K971317 NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS National Healthcare Mfg. Corp. KDD Class I 1997-05-08
K964114 DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS Depuy, Inc. FXX Class II 1997-05-06
K971217 INSTRUMENT TRAY LINER General Hospital Supply Corp. FSM Class I 1997-05-06
K971187 STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE Aaron Medical Industries JOS Class II 1997-05-05
K970530 ANSPACH LUBRICATING SYSTEM II The Anspach Effort, Inc. GEY Class I 1997-05-05
K970987 ELECTROSURGICAL ELECTRODE Fusion Medical Technologies, Inc. GEI Class II 1997-05-05
K932683 CENTAURI Premier Laser Systems, Inc. GEX Class II 1997-05-05
K933841 CENTAURI Premier Laser Systems, Inc. GEX Class II 1997-05-05
K970863 MODIFIED USSC* POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1997-05-05
K970400 BONE SOURCE HYDROXYAPATITE Orthofix, Inc. LZK Class II 1997-05-02
K970493 HYFRECATOR 2000 Aspen Labs GEI Class II 1997-04-30
K970378 STRYKER 2115 REPLACEMENT BATTERY (2115) Implant Resource, Inc. KIJ Class I 1997-04-30
K970448 PCM 2000; ISOLAIR APR MODEL 2735 Tecnol Medical Products, Inc. MSH Class II 1997-04-30
K965199 TUNA 5 CATHETER Vidamed, Inc. GEI Class II 1997-04-30
K970345 ALIGNMENT INSTRUMENT Richard Wolf Medical Instruments Corp. HSZ Class I 1997-04-29
K970317 MODIFIED E-PACK PROCEDURE KIT ETHICON, Inc. GAM Class II 1997-04-25
K963996 (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 Full Spectrum, Inc. GEX Class II 1997-04-24
K963991 FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS Full Spectrum, Inc. GEX Class II 1997-04-24
K971092 QA-ES Smith GEI Class II 1997-04-23
K962087 SERVOTRONIC EC100 SYSTEM Medicon, Inc. HWE Class I 1997-04-23
K964440 EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS) Maxxim Medical KGO Class I 1997-04-22
K970416 ACUFEX DOUBLE ARMED SUTURE NEEDLE Smith & Nephew Endoscopy, Inc. GAT Class II 1997-04-21
K970422 RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS Trimedyne, Inc. GEX Class II 1997-04-21
K964585 RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) Trimedyne, Inc. GEX Class II 1997-04-17
K963305 ALEXANDER BOX, BATTERY, RECHARGEABLE Alexander Mfg. Co. BWA Class II 1997-04-17
K963646 STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW Stryker Endoscopy GEI Class II 1997-04-16
K970439 PROXIDERM (D-460,D 90 460,D 180,460, PS 460) Progressive Surgical Products, Inc. MKY Class I 1997-04-16
K971040 CABLE HOLDER, SUCTION TUBE HOLDER Contour Fabricators, Inc. GEI Class II 1997-04-16
K970886 HANAULUX BLUE 80 HOSPITAL Heraeus Med GmbH FSS Class II 1997-04-16
K964849 ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM Arthrocare Corp. GEI Class II 1997-04-14
K955653 VENISECT LASER LANCET Venisect, Inc. GEX Class II 1997-04-11
K970184 OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES Olympus America, Inc. GEI Class II 1997-04-11
K964253 DERMA 20 LASER SYSTEM Esc Medical Systems , Ltd. GEX Class II 1997-04-11
K970185 STERILE DISPOSABLE EQUIPMENT MAGNET COVER Contour Fabricators, Inc. KKX Class II 1997-04-10
K970576 SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) Somnus Medical Technologies, Inc. GEI Class II 1997-04-09
K964534 OTOSILK OTOLOGICAL GRAFT DRESSING Boston Medical Products, Inc. NAD Class I 1997-04-09
K970088 RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: Richard Wolf Medical Instruments Corp. HWE Class I 1997-04-07
K970157 LASERSCOPE AUTOMATIC EYE PROTECTION FILTER Laserscope GEX Class II 1997-04-07
K970637 ACCUCURE 1000 Lasermed, Inc. GEX Class II 1997-04-02
K970924 REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE Regent Medical KGO Class I 1997-04-01
K964074 DIOLITE 532 Iriderm Div. GEX Class II 1997-04-01
K970722 EYE TRAY Trinity Laboratories, Inc. KKX Class II 1997-03-31
K964971 CRYOGEN CRYOSURGICAL SYSTEM Cryogen, Inc. GEH Class II 1997-03-28
K963293 AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX Augustine Medical, Inc. MSA Class I 1997-03-28
K970140 E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH Valleylab, Inc. GEI Class II 1997-03-28
K970826 SELECTA-TIP LAPAROSCOPIC SCISSORS Microline Pentax, Inc. GEI Class II 1997-03-28
K970130 HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING Medtrex, Inc. GEI Class II 1997-03-28
K970541 AESCULAP MODULAR MONOPOLAR ELECTRODES Aesculap, Inc. GEI Class II 1997-03-28
K970815 CONVERTORS IMPERVIOUS SHOE COVERS Allegiance Healthcare Corp. FXP Class I 1997-03-27
K970440 EKONIC DENTAL/MEDICAL MASK (MD 610) Ekonic Company, Ltd. FXX Class II 1997-03-27
K963775 MODEL 8800 ASPIRATOR Medical Specifics, Inc. BTA Class II 1997-03-26
K964336 CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 Cryomedical Sciences, Inc. GEH Class II 1997-03-20
K932221 NEUROLOGICAL OR CRANI TRAYS (PACKS) Associated Medical Products Co. LRO Class II 1997-03-19
K964047 CRYOSIL SILICONE GEL SHEETING Biodermis Corp. GEH Class II 1997-03-19
K970017 NIDEK CYBERSCAN Nidek, Inc. GEX Class II 1997-03-18
K970361 LASER EYE GOGGLES Stefanovsky & Assoc. GEX Class II 1997-03-18
K964128 MCL 29 DERMABLATE ERBIUM LASER SYSTEM Aesculap-Meditec GmbH GEX Class II 1997-03-17
K961380 CPC PROBE Carl Zeiss, Inc. GEX Class II 1997-03-17
K970807 MOBILE OPERATING TABLE 1132.01 Stierlen-Maquet AG GDC Class I 1997-03-14
K965015 TOPAZ 30 SURGICAL LASER SYSTEM Esc Medical Systems, Inc. GEX Class II 1997-03-14
K962109 SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL Classy Lady by Mehl of Puerto Rico, Inc. GEX Class II 1997-03-13
K962791 NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM New Star Lasers, Inc. GEX Class II 1997-03-13
K964636 FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM Valleylab, Inc. GEI Class II 1997-03-11
K965107 MEDLINE ADMISSION KITS Medline Industries, Inc. FXX Class II 1997-03-11
K964474 ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES Allegiance Healthcare Corp. KGO Class I 1997-03-11

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