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
1989-11-03

Clearances · page 127 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896087 PALESTRANT IRRIGATION AND DRAINAGE SET North American Instrument Corp. KGZ Class I 1989-11-03
K895845 2018 ARTERIAL/VENOUS PRESSURE DRESSING Advance Medical Designs, Inc. NAD Class I 1989-11-01
K895950 MODEL FEL5100 FLOOR LIGHT F.W. Lang Co. FSS Class II 1989-10-31
K894256 STERILE SURGEONS GLOVES Chung Shiang Rubber Industrial Co. KGO Class I 1989-10-31
K895252 ULTRACISION ULTRASONIC SCALPEL Ultracision, Inc. GEI Class II 1989-10-31
K894493 BINDER SUBMALAR FACIAL IMPLANT Implantech Associates, Inc. LZK Class II 1989-10-27
K894010 SURGICAL GLOVES Green Cross Medical Supplies Corp. KGO Class I 1989-10-27
K895786 ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400 Luxar Corp. GEX Class II 1989-10-27
K895152 BINDER SUBMALAR FACIAL IMPLANT II Implantech Associates, Inc. LZK Class II 1989-10-27
K895299 LASERMEDIC 1200 RUBY LASER SYSTEM Lasermetrics, Inc. GEX Class II 1989-10-24
K894380 DUMON TRACHEOBRONCHIAL STENT Bryan Corp. NWA Class II 1989-10-24
K895727 BACKGROUND SUCTION MATT Applied Medical Technologies, Inc. NAB Class I 1989-10-24
K895726 VESSEL OCCLUDER Applied Medical Technologies GDJ Class I 1989-10-24
K895681 CONTRAST BACKGROUND MATERIAL Applied Medical Technologies GAB Class I 1989-10-24
K895682 VESSEL LOOPS Applied Medical Technologies GDX Class I 1989-10-24
K895683 BERNARD VESSEL APPROXIMATOR Applied Medical Technologies HRQ Class I 1989-10-24
K895559 MODIFIED ENDOGUIDE Luxar Corp. GEX Class II 1989-10-20
K895409 REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER Remington Products Company, LLC LEJ Class II 1989-10-20
K895263 ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS Heraeus Lasersonics, Inc. GEX Class II 1989-10-20
K895591 SILICONE INSTRUMENT SHODS Key Surgical, Inc. GDJ Class I 1989-10-20
K895348 MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT Lasag Medical Lasers GEX Class II 1989-10-20
K895757 IRRI-EVACUATOR Mikro-Tek Laboratories GBX Class I 1989-10-19
K895762 CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC Kolster Methods GEA Class I 1989-10-18
K895761 GENERAL ASPERATOR Kolster Methods JCX Class II 1989-10-18
K895752 DIAMOND BLADE SURGICAL KNIVES Magnum Diamond, Inc. GDM Class I 1989-10-17
K895285 MENTOR DUCTAL CATHETERS Mentor Corp. GBZ Class I 1989-10-17
K895029 SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION Surgical Laser Technologies, Inc. GEX Class II 1989-10-16
K891404 STERILE LATEX SURGEON'S GLOVES Shinheng Corp. KGO Class I 1989-10-16
K895041 OPTICAL CATHETER(TM) INTRODUCER SETS Medical Dynamics, Inc. KGZ Class I 1989-10-16
K895667 STERILE SURGICAL GOWN Clinitech, Inc. FYE Class I 1989-10-13
K895715 HANAULUX(R) 2000 W.C. Heraeus GmbH FTD Class II 1989-10-13
K892495 SURGEON'S GLOVES Care-Pro Industries, Inc. KGO Class I 1989-10-11
K892499 SAFETY SURGEONS GLOVES Advance Rubber, Inc. KGO Class I 1989-10-11
K894977 OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM Trimedyne, Inc. GEX Class II 1989-10-10
K894580 GORE-TEX SURGICAL TAPE W. L. Gore & Associates, Inc. FTM Class II 1989-10-10
K894708 PT DISTAL TIP CEMENT SPACER Osteonics Corp. JDK Class II 1989-10-10
K895073 POW-IR TIP Living Technology, Inc. GEX Class II 1989-10-10
K893598 HYDRAULIC FOOT OPERATED STOOL Arthro-Medic, Inc. GBB Class I 1989-10-10
K895448 RUBBER LATEX SURGICAL GLOVES, STERILE Dah Lee Rubber Industries (Thai) , Ltd. KGO Class I 1989-10-10
K894591 GYNEGUIDE Marlo Surgical Technology GEX Class II 1989-10-10
K895603 S.S.T. SURGICAL THIMBLE Healthcare Technologies Resources, Inc. KGO Class I 1989-10-06
K895404 UNDER BUTTOCKS DRAPE Medical Plastics, Inc. KKX Class II 1989-10-06
K895551 ROCKET BONE MARROW NEEDLE A & A Medical, Inc. GDM Class I 1989-10-06
K895594 SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE Go Medical Industries Pty. , Ltd. GDM Class I 1989-10-06
K895527 THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM Quantitative Technologies, Inc. FSM Class I 1989-10-06
K894841 IRIS OCULIGHT(TM) SL Iriderm Div. GEX Class II 1989-10-05
K894490 STERILE ULTRASOUND TRANSMISSION GEL Swedish Trade Council USA JOT Class II 1989-10-05
K895746 SHARPLAN MODEL 710 MICROSPOT Sharplan Lasers, Inc. GEX Class II 1989-10-05
K894709 NIDEK MODEL ADC-8000 Nidek, Inc. GEX Class II 1989-10-04
K890658 SYRINGE INJECTION GUN DELIVERY KITS Gastrotech, Inc. LRO Class II 1989-10-03
K894319 MEDICAL DYNAMICS LIGHT SOURCE Medical Dynamics, Inc. FSW Class II 1989-10-03
K894166 THERMOSURGERY TM Rdm Intl., Inc. GEI Class II 1989-10-03
K885229 MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS Romano Surgical Instrumentation, Inc. HSZ Class I 1989-09-29
K894765 SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 Laser Industries , Ltd. FYD Class II 1989-09-28
K894038 PLUME-AWAY SMOKE EVACUATION SYSTEM Laser Technologies Group, Inc. FYD Class II 1989-09-28
K892655 ACL DRILL GUIDE SYSTEM Baxter Healthcare Corp LXI Class I 1989-09-28
K894962 CO2 LASER BRONCHOSCOPE COUPLER Cuda Products Co. GEX Class II 1989-09-28
K895369 VOSS GRAFT MARKER Voss Medical Products KPK Class II 1989-09-27
K895670 SURGICAL SUCTION APPARATUS Baker-Sundt Research, Inc. GEA Class I 1989-09-27
K895212 TIK EXTRAKTOR Instruments of Sweden, Inc. HTD Class I 1989-09-27
K895042 SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY Sharplan Lasers, Inc. GEX Class II 1989-09-27
K895027 MEDPRIDE LATEX SURGEONS GLOVES Medpride KGO Class I 1989-09-26
K895092 KUT-SHIELD Kut-Guard, Inc. FYH Class I 1989-09-26
K895143 COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS Lumenis, Inc. GEX Class II 1989-09-25
K891129 SERIES 3 GENERAL SUCTION SYSTEM Ultravac, Inc. BTA Class II 1989-09-25
K894874 14 INCH BULLET POINT NEEDLE R. J. Doyle, Inc. GAA Class I 1989-09-22
K894872 16 GA X 6 BULLET POINT NEEDLE R. J. Doyle, Inc. GAA Class I 1989-09-22
K894873 16 GA X 10 BULLET POINT NEEDLE R. J. Doyle, Inc. GAA Class I 1989-09-22
K894875 20GA X 7-1/2 THREADING BULLET POINT NEEDLE R. J. Doyle, Inc. GAA Class I 1989-09-22
K890722 ADG BONE BIOPSY SYSTEM American Design Group, Inc. GDM Class I 1989-09-21
K895235 VARIOUS DISPOSABLE SURGICAL GARMENTS Protect Corp. of Indiana, Inc. FYE Class I 1989-09-19
K894073 INAMED PRO-TEC SILICONE SURGICAL GLOVES Inamed Development Co. KGO Class I 1989-09-18
K895093 SLT CONTACT LASER SYSTEMS Surgical Laser Technologies, Inc. GEX Class II 1989-09-18
K894663 BEAMER ONE Beacon Laboratories, Inc. HAM Class II 1989-09-15
K895331 ELECTROSURGICAL ELECTRODE New England Surgical Instrument Corp. JOS Class II 1989-09-15
K895337 ELECTROSURGICAL COAGULATION SUCTION TUBE New England Surgical Instrument Corp. HAM Class II 1989-09-15
K895325 SUNTANNING BED Sunbronze LEJ Class II 1989-09-15
K895202 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT Transidyne General Corp. LRO Class II 1989-09-15
K895248 IMS5000 ILLUMINATED LOUPES Luxtec Corp. FSP Class I 1989-09-15
K894762 B100 DISPOSABLE HANDPIECE Beacon Laboratories, Inc. HAM Class II 1989-09-15
K895011 TRIDENT DRAPE SUPPORT Trident Medical Products, Inc. KKX Class II 1989-09-15
K895198 HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM Zimmer, Inc. HWE Class I 1989-09-15
K894383 DISPOSABLE SHOE COVER American Threshold Industries, Inc. FXP Class I 1989-09-12
K894186 SURGIFLEX LASER CONTACT TIPS Cabot Medical Corp. GEX Class II 1989-09-12
K894516 VISOSHIELD(TM), SURGICAL EYE PROTECTOR Polamedco, Inc. FXX Class II 1989-09-12
K894905 FACE PROTECTION PAK(TM) Protech Products FXX Class II 1989-09-12
K895121 INTERMEDICS POWER BROACH IMPACTOR Intermedics Orthopedics HSZ Class I 1989-09-11
K894427 DISPOSABLE IV INDUCTION COVER Central Plastic, Inc. FMK Class II 1989-09-11
K892108 STERILE NATURAL LATEX SURGICAL GLOVES Ruhn Chang Industrial Co., Ltd. KGO Class I 1989-09-08
K892176 CORRECT TOUCH SURGEONS GLOVES Ampri Rubberware Industries Sdn Bhd KGO Class I 1989-09-06
K893899 STERILE LATEX SURGICAL GLOVES Life Force Laboratories, Inc. KGO Class I 1989-09-06
K891622 STERILE SURGICAL NATURAL LATEX GLOVES Ct Intl. KGO Class I 1989-09-06
K894984 MASCOT LAB SPONGE Mascot, Inc. GDY Class I 1989-09-05
K894254 HYPAFIX DRESSING RETENTION SHEET Smith & Nephew United, Inc. NAD Class I 1989-08-31
K894789 DMI 250 SERIES POWER SURGERY TABLE M.D. Intl., Inc. JEA Class I 1989-08-29
K894164 MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND Heraeus Lasersonics, Inc. GEX Class II 1989-08-29
K894134 POWER EXAMINATION TABLE MODEL # 411 Midmark Corp. LGX Class I 1989-08-28
K894144 POWER EXAMINATION TABLE MODEL # 405 Midmark Corp. LGX Class I 1989-08-28
K894074 CO2 SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1989-08-24
K894220 HOUTS HYSTERECTOMY DRAIN Helix Medical, Inc. GBW Class I 1989-08-24

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