meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
52
Latest Decision
1984-11-08

Clearances · page 146 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843140 ISOLATE ADHESIVE BANDAGE FOR DRY WOUND Chesebrough-Pond'S U.S.A. Co. NAD Class I 1984-11-08
K834343 COMFEEL POWDER Coloplast A/S KOZ Class I 1984-11-08
K843139 ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND Chesebrough-Pond'S U.S.A. Co. NAD Class I 1984-11-08
K844177 COSGROVE MITRAL VALVE RETRACTOR Kapp Surgical Instrument, Inc. GAD Class I 1984-11-08
K844199 ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET Kleen Test Products KKX Class II 1984-11-07
K844152 HEMSTATS I M, Inc. HRQ Class I 1984-11-07
K841781 MODEL 305AA PORTABLE LASER Laser Spectrum, Inc. GEX Class II 1984-11-07
K843906 SNYDER HEMOVAC WOUND DRAINAGE DEVICES Snyder Laboratories, Inc. GBS Class I 1984-11-05
K844039 AZTECH INDUSTRIES SUNTANNING BED AZ100 Aztech Industries, Inc. FTC Class II 1984-11-05
K843399 SURGEONS CHOICE PI VASCULAR STAPLING Surgeons Choice, Inc. GDW Class II 1984-11-05
K843925 GILL'S IRRIGATOR/ASPIRATOR NEEDLE Concept, Inc. GAA Class I 1984-11-05
K843693 JACOBS HIGH VACUUM SUCTION UNIT 05-2570 J. Sklar Mfg. Co., Inc. BTA Class II 1984-10-31
K843336 AUTOMATIC MULTICLIP DISPOS. LIGATING Davis & Geck, Inc. FZP Class II 1984-10-31
K843496 DRAPE SURGICAL UTILITY DRAPE STERILE Busse Hospital Disposables, Inc. KKX Class II 1984-10-31
K843816 TAL-CLIP Talboy, Inc. GDJ Class I 1984-10-31
K841591 PYRO-TIP Suncoast Medical Manufacturers, Inc. GEI Class II 1984-10-31
K842703 ND-YAG LASER 8000 NEUROSURGERY APPLICA Cooper Lasersonics, Inc. GEX Class II 1984-10-31
K843187 CANNULA ETHICON, Inc. GEA Class I 1984-10-31
K842710 CONCEPT C-VAC Concept, Inc. GCY Class I 1984-10-31
K843475 PHARMA-PLAST SINGLE USE OVERSHOES Zimmar Consulting , Ltd. FXP Class I 1984-10-31
K843497 SURGICAL KNIVES & PROBES Eder Instrument Co, Inc. EMF Class I 1984-10-31
K843564 MSI SURGI-GRADE SUTURE TRAY Medical Sterilization, Inc. FSM Class I 1984-10-31
K843306 UVA SUNTANNING UNITS VARIOUS MODELS Topsolo Sun Systems FTC Class II 1984-10-31
K843603 AUTO SUTURE POLY GIA SURGICAL STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1984-10-31
K843830 J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI Popper & Sons, Inc. GDM Class I 1984-10-26
K843890 CUSTOM INSTRUMENT DRAPE Lifestream Int'L, Inc. HMW Class II 1984-10-26
K840376 SURG-A STAT LOOP TIP Suncoast Medical Manufacturers, Inc. GEI Class II 1984-10-26
K843371 VALVOTOMY KNIFE Downs Surgical , Ltd. EMF Class I 1984-10-25
K843801 MASON EQUIPMENT ORGANIZER & ASPEN Aspen Laboratories, Inc. FSE Class I 1984-10-25
K843734 NEMDI Nemectron Medical, Inc. KCX Class I 1984-10-25
K843735 SOFTEPIL Nemectron Medical, Inc. KCX Class I 1984-10-25
K843647 MTI 1200, 401 & 3500 Manufactured Tan Intl. FTC Class II 1984-10-25
K843814 EMUMOL ULTRAVIOLET SUNTANNING LAMP Mottek Intl. Corp. FTC Class II 1984-10-25
K843690 ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE Popper & Sons, Inc. GDM Class I 1984-10-25
K843400 HYDRO-SPLINT A SPONGE-COMPRESS DRESS Compression Splint Products, Inc. FYH Class I 1984-10-24
K843589 TICLIP STERIAL DISPOSABLE Western Medical Products, Inc. FZP Class II 1984-10-24
K843575 DERBYSHIRE DRAIN Sil-Med Corp. GBW Class I 1984-10-24
K843617 SDC SILICONE SUMP DRAIN Science Development Corp. GBX Class I 1984-10-24
K843561 MSI SURGI-GRADE UNIVERSAL TRACH TRAY Medical Sterilization, Inc. FSM Class I 1984-10-24
K843593 SURGIPRESS SURGICAL LOOP Syntex Corp. HRQ Class I 1984-10-24
K842009 ABDOMINAL PARACENTESIS TRAY Jayco Pharmaceuticals FSM Class I 1984-10-23
K842622 HEMO STATIC/ESU SCALPEL SYSTEM Oximetrix, Inc. GEI Class II 1984-10-23
K843723 STERILE INSTRUMENT TRAYS-VARIOUS E.M. Adams FSM Class I 1984-10-23
K843563 MSI SURGI-GRADE INCISION & DRAIN TRAY Medical Sterilization, Inc. FSM Class I 1984-10-23
K841483 ALL PURPOSE ELECTROSURGICAL GENERATOR Concept, Inc. GEI Class II 1984-10-23
K843081 TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT Creative Medical Laboratories, Inc. JCX Class II 1984-10-11
K843750 APPARATUS, SUCTION, WARD USE, PORTAB- H.C.H. Products, Inc. BTA Class II 1984-10-11
K842595 MICROELECTRODE Surgical Safety GEI Class II 1984-10-10
K842596 MICROPENCIL Surgical Safety GEI Class II 1984-10-10
K843197 VISITEC EYE SHIELD Visitec Co. HMP Class I 1984-10-05
K843374 ND-YAG LASER FOR PALLIATION OF GI MALIGN Endo Lase, Inc. LNK Class II 1984-10-02
K843240 LASER FOR GENITOURINARY APPLIC. 4000 Cooper Lasersonics, Inc. LNK Class II 1984-10-02
K843293 ND-YAG LASER FOR UROLOGICAL SURGERY Endo Lase, Inc. LNK Class II 1984-10-02
K843156 BIOLAS YAG 100 CILAS, ERCELAS YAG 100 Advanced Biomedical Instruments LNK Class II 1984-10-01
K843100 INSTRUMENTS FOR MICRO ANASTOMOSIS Downs Surgical , Ltd. GAD Class I 1984-09-27
K833377 MEDICALEX Medicalex GEA Class I 1984-09-27
K843063 ELECTRONIC EPILATOR TS-1 R. A. Fischer Co. Corp. KCW Class I 1984-09-26
K842627 C-SECTION TRAY Deroyal Industries, Inc. KDD Class I 1984-09-26
K843125 PERRY DERMAGUARD SURGICAL GLOVES Perry, Div. KGO Class I 1984-09-25
K843136 BRIMFIELD CANNULATED GRASPING HOOKS Brimfield Scientific Instruments GDG Class I 1984-09-25
K842574 THE CLINICIAN Solidstate Systems Corp. GEI Class II 1984-09-25
K842931 DRABKIN REAGENT E K Ind., Inc. KAG Class I 1984-09-21
K843260 ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE Angiosystems, Inc. KKX Class II 1984-09-21
K843216 ECLIPSE HEART SUPPORT FOR CORONARY ARTER Biotrac Laboratories GAD Class I 1984-09-20
K842648 GENERAL SURGERY TRAY Deroyal Industries, Inc. LRO Class II 1984-09-20
K840739 MEDILASER-S MEL-444-S Mochida Pharmaceutical Co., Ltd. GEX Class II 1984-09-20
K842666 NU-THOR THORACOSTOMY KIT Intl. Medical Devices , Ltd. KGZ Class I 1984-09-20
K834166 BARD CO2 SURGICAL LASER SYS SLS-50/100 C.R. Bard, Inc. GEX Class II 1984-09-18
K842475 RICHARDS INTRA-ARTICULAR SHAVER MOTOR Richards Medical Co., Inc. GEY Class I 1984-09-17
K843034 DISPOSABLE LINEAR CUTTER ETHICON, Inc. GDW Class II 1984-09-17
K842698 BRITISH SPINAL FUSION SET Downs Surgical , Ltd. FZX Class I 1984-09-12
K842700 BASILDON-GARDNER SPINAL FRAME Downs Surgical , Ltd. FWZ Class I 1984-09-12
K843134 MOBILE OPERATING TABLE HEIDELBERGS 1130 Stierlen-Maquet AG GDC Class I 1984-09-07
K843121 GUIDE TO THE KNEE Dyonics, Inc. BWN Class I 1984-09-07
K843115 STERILE SOLUTION BOWL E.M. Adams KDD Class I 1984-09-07
K843083 CORMED HUBER POINT NEEDLE Cormed, Inc., Sub. C.R.Bard, Inc. GAA Class I 1984-09-05
K841795 UV 8001K, PUVA 800, PUVA 180/200 1000 Waldmann Lighting Co. KGL Class II 1984-08-30
K841618 THREADING TUBE Plastafil, Inc. FZX Class I 1984-08-27
K841617 STROVER HOOK Plastafil, Inc. HCF Class I 1984-08-27
K841625 HOOK Plastafil, Inc. GAD Class I 1984-08-27
K842186 ACU-DERM TRANSPARENT WOUND DRESSING Acme United Corp. NAD Class I 1984-08-24
K840406 MICROSURGICAL CO2 LASER SYS - 4100 Bio Quantum Technologies, Inc. GEX Class II 1984-08-20
K843116 DISPOSABLE SKIN MARKING PEN E.M. Adams FZZ Class I 1984-08-17
K842762 OMNI-TRACT SURGICAL RETRACTOR SYS Minnesota Scientific, Inc. GAD Class I 1984-08-17
K843074 DISPOS. & SPONGE FORCEPS PEAN ARTERY Greene International Corp. GEN Class I 1984-08-17
K842963 RHYS-DAVIES EXSANGUINATOR Woodville Polymer Engineering, Ltd. KCY Class I 1984-08-17
K842975 BROWNIE BOOTH BB1 Weingart, Inc. FTC Class II 1984-08-17
K842958 BOUNDARY SINGLE-USE OR GOWN Procter & Gamble Mfg. Co. FYA Class II 1984-08-17
K842992 GRASSHOPPER - RETRACTOR Norton Texas Medical Products GAD Class I 1984-08-17
K840946 MICROPOROUS HYPOALLERGENIC Gainor Medical KGW Class II 1984-08-17
K842765 SILIMED BREAST FORM Sil-Med Corp. GBI Class I 1984-08-17
K842230 AIMED DISPOS. INJECTION NEEDLE Tech-Cons Ltd., Intl. GAA Class I 1984-08-17
K842787 SUNBED Sun Health Systems FTC Class II 1984-08-15
K842572 GAUZE & LAB SPONGES STERILE & NON Ulti-Med Intl., Inc. GDY Class I 1984-08-15
K841980 SIDE CUTTING SERRATED BLADE Stainless Mfg., Inc. HTZ Class I 1984-08-15
K841548 HEMOCLIP LIGATING CLIPS M/LARGE Edward Weck, Inc. FZP Class II 1984-08-14
K841549 HEMOCLIP AUTOMATIC CLIPS MEDIUM Edward Weck, Inc. FZP Class II 1984-08-14
K842819 HOOK PUNCH FORCEPS FOR ARTHROSCOPY Medtech Industries, Inc. HTD Class I 1984-08-14
K841547 HEMOCLIP LIGATING CLIPS MED/SML Edward Weck, Inc. FZP Class II 1984-08-14
K842382 3M RAPIDSTAT LIGATING CLIP SYS 3M Company FZP Class II 1984-08-10

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