meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
43
Latest Decision
1990-02-16

Clearances · page 126 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895018 SURGICAL GLOVES Lon Tai Chemical Industrial Co., Ltd. KGO Class I 1990-02-16
K896549 STORZ FIBEROPTIC ENDO-ILLUMINATORS Storz Instrument Co. HBI Class II 1990-02-15
K897192 TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE Baxter Healthcare Corp KGO Class I 1990-02-15
K896215 MERCY HIP/KNEE PACK Westmark, Sterile Packing Systems, Inc. (Sps) KKX Class II 1990-02-13
K897040 LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.) Luxar Corp. GEX Class II 1990-02-13
K896303 BIOPSY PUNCH Premier Medical LRY Class I 1990-02-13
K900479 STERILE LACERATION TRAY CAT. #749 Busse Hospital Disposables, Inc. FSM Class I 1990-02-13
K896055 ERBOTOM ACC 450 Erbe Electromedizin GmbH GEI Class II 1990-02-13
K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS Micro-Aire Surgical Instruments, Inc. GEY Class I 1990-02-13
K896997 ATRAUCLIP (TITANIUM HEMOSTATIC CLIP) S.P.K. Technology, Inc. FZP Class II 1990-02-13
K900332 EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE 3M Company GEI Class II 1990-02-13
K896838 BISTAT ELECTROSURGICAL UNIT 60-5400-001 Aspen Laboratories, Inc. GEX Class II 1990-02-13
K900055 MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS United States Surgical, A Division of Tyco Healthc GDW Class II 1990-02-09
K885309 WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS Wilson-Cook Medical, Inc. ESW Class II 1990-02-09
K900043 MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 1990-02-09
K900144 QUARTZ FIBER CATHETERS AND SURGICAL TIPS Pfizer Laser Systems GEX Class II 1990-02-09
K896517 ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER Heraeus Lasersonics, Inc. GEX Class II 1990-02-09
K895293 KEMI LABS - ADHESIVE BANDAGE REMOVER Kemi Labs, Inc. KOX Class I 1990-02-09
K900487 MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE United States Surgical, A Division of Tyco Healthc GDH Class I 1990-02-09
K896478 LUXAR MODEL LX-20 MINILASE CO2 LASER Luxar Corp. GEX Class II 1990-02-08
K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 Micro-Aire Surgical Instruments, Inc. HSZ Class I 1990-02-02
K896183 KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY Laserscope GEX Class II 1990-02-02
K896839 MF-450 ELECTROSURGICAL UNIT 60-5500-001 Aspen Laboratories, Inc. GEI Class II 1990-02-02
K896412 GAS MIXTURES AS DEVICE COMPONENTS Spectra Gases, Inc. GEX Class II 1990-02-01
K896432 RUBBER LATEX SURGEON'S GLOVE Regent Hospital Products KGO Class I 1990-02-01
K896541 MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III Valley Forge Scientific Corp. GEI Class II 1990-01-29
K896847 SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM Sharplan Lasers, Inc. GEX Class II 1990-01-24
K900175 4/1 ARMBOARD Infection Control Products, Inc. BTX Class I 1990-01-24
K900160 ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER Jedmed Instrument Co. KQM Class I 1990-01-24
K895823 SURGEON'S GLOVES Guey Her Ent. Co. , Ltd. KGO Class I 1990-01-24
K896988 NIIC LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1990-01-23
K895817 HERMAL WOUND CARE KIT Stiefel Research Institute, Inc. NAD Class I 1990-01-19
K892899 STERILE LATEX SURGICAL GLOVE Tomarc (M) Sdn Bhd KGO Class I 1990-01-17
K897028 LINCOLN MILLS FOOT AND LEG HOLDER Lincoln Mills, Inc. FWZ Class I 1990-01-12
K896049 35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM Pfizer Laser Systems GEX Class II 1990-01-11
K896822 SURGISMOKE Spectro Industries, Inc. FYD Class II 1990-01-11
K896626 HAND CONTROLLED ELECTROSURGICAL PENCILS Conmedcorp GEI Class II 1990-01-11
K896711 LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE Luxar Corp. GEX Class II 1990-01-09
K896619 LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE Luxar Corp. GEX Class II 1990-01-09
K896618 LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE Luxar Corp. GEX Class II 1990-01-09
K896617 LISTING ENT AS INTENDED USE FOR ENDOGUIDE Luxar Corp. GEX Class II 1990-01-09
K896724 CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. Stiefel Research Institute, Inc. GEH Class II 1990-01-09
K896595 LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE Luxar Corp. GEX Class II 1990-01-09
K896491 INAMED CLOSED-WOUND DRAIN SYSTEM Inamed Development Co. GCY Class I 1990-01-08
K897120 EQUIP COVERS, STERILE Amedic USA KKX Class II 1990-01-04
K896606 JACKSON FINE NEEDLE ASPIRATION SYSTEM National-Standard Medical Products GAA Class I 1990-01-04
K896605 KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG) National-Standard Medical Products GAA Class I 1990-01-04
K896983 SUNBRONZE SB24C/65 ULTRA Sunbronze LEJ Class II 1990-01-03
K896674 AMSCO QUANTUM LIGHT American Sterilizer Co. FSY Class II 1990-01-03
K895774 GYN-PROBE Trimedyne, Inc. GEX Class II 1990-01-03
K895874 OPTILASE YAG MODEL 1000 Trimedyne, Inc. GEX Class II 1990-01-03
K896019 MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI. Dlp, Inc. GAA Class I 1990-01-03
K896262 TITANIUM LIGATING CLIPS Richard-Allan Medical Ind., Inc. HBT Class I 1990-01-02
K896191 SUNTANNING BED, INC. T12 UVA TANNING LAMPS Sunbronze FTC Class II 1989-12-27
K895756 MIKRO-AQUAPURATOR Mikro-Tek Laboratories GBX Class I 1989-12-27
K896831 ALISUN SUNTANNING BED Alisun America, Ltd. FTC Class II 1989-12-27
K895516 CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 Arrow Intl., Inc. GBX Class I 1989-12-27
K896792 SURGICAL SKIN MARKER Westmark, Sterile Packing Systems, Inc. (Sps) FZZ Class I 1989-12-27
K896589 MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP Optik LRZ Class I 1989-12-27
K896803 CLOSED WOUND RESERVOIR Westmark, Sterile Packing Systems, Inc. (Sps) GCY Class I 1989-12-27
K896390 WILSON-COOK ESOPHAGEAL PROSTHESIS Wilson-Cook Medical, Inc. JCQ Class II 1989-12-27
K895755 MIKRO-LAVAGE-1 Mikro-Tek Laboratories GBX Class I 1989-12-27
K895012 E-Z-EM VACUUM ASPIRATION SYRINGE E-Z-Em, Inc. GAA Class I 1989-12-27
K895837 MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR Medical Laser, Inc. GEX Class II 1989-12-14
K896472 KEY VASCULAR BOOTIES Key Surgical, Inc. MAW Class I 1989-12-14
K893834 ACCUMED LATEX SURGICAL GLOVE Accurate Medical Devices, Inc. KGO Class I 1989-12-14
K895918 STERILE DISPOSABLE INFRATIP Heraeus Lasersonics, Inc. GEX Class II 1989-12-14
K896533 SPENCO BREAST FORMS Spenco Medical Corp. KCZ Class I 1989-12-13
K895581 MODEL: IR205 ARTICULATED SURGICAL LASER Niic U.S.A., Inc. GEX Class II 1989-12-13
K896383 DISPOSABLE EXTERNAL CLAMPS Galenica Enterprises, Inc. GDI Class I 1989-12-06
K896367 STERILE SURGICAL DRAPES AND SHEETS Clinitech, Inc. KKX Class II 1989-12-04
K895663 SITE 810E PHOTOCOAGULATOR AND ACCESSORIES Site Microsurgical Systems, Inc. GEX Class II 1989-12-04
K895518 COHERENT HOLMIUM:YAG SURGICAL LASER Lumenis, Inc. GEX Class II 1989-11-30
K895430 HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 Heraeus Lasersonics, Inc. GEX Class II 1989-11-28
K896051 LONE STAR TRADING SURGICAL GLOVE Lone Star Trading Pte. , Ltd. KGO Class I 1989-11-28
K895410 REMINGTON TANFASTIC HANDHELD TANNING WAND Remington Products Company, LLC FTC Class II 1989-11-27
K896369 TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM Techmedica, Inc. EZX Class II 1989-11-24
K896176 EXUSORB(TM) DRY/WET DRESSING Controlled Therapeutics Corp. KOZ Class I 1989-11-24
K896165 STERILE HYPOALLERGENIC SURGEONS' GLOVES Isratech Marketing Corp. KGO Class I 1989-11-22
K895378 PROXIMAL CEMENT SPACER Osteonics Reconstructive Products Div. JDK Class II 1989-11-22
K896280 MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 Micro-Aire Surgical Instruments, Inc. GFA Class I 1989-11-22
K892922 LATEX SURGICAL GLOVES Millimax Corp. KGO Class I 1989-11-21
K896310 ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE Acufex Microsurgical, Inc. KGS Class I 1989-11-20
K895684 SOFT SUCTION ADAPTER Applied Medical Technologies GEA Class I 1989-11-20
K895239 MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER Niic U.S.A., Inc. GEX Class II 1989-11-16
K896434 AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* United States Surgical, A Division of Tyco Healthc GEA Class I 1989-11-16
K881334 LIGHT COAGULATOR LC 250 Nk-Optik GmbH HAM Class II 1989-11-16
K892359 MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1989-11-16
K895247 MODEL IR103 SURGICAL LASER SYSTEM Niic U.S.A., Inc. GEX Class II 1989-11-16
K895841 MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE. Everest Medical Corp. GEI Class II 1989-11-15
K894928 STERILE LATEX SURGEON'S GLOVES Gigantic International Corp. KGO Class I 1989-11-15
K894471 SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY Surgilase, Inc. GEX Class II 1989-11-14
K896085 SURGI-BRUSH Sparta Surgical Corp. GEC Class I 1989-11-08
K895279 LASERMATIC COMBOLASER MODEL 5050 Lasermatic OY GEX Class II 1989-11-08
K895737 THE DOCTOR'S CHOICE ELECTRODE The Skin Care Centre GEI Class II 1989-11-08
K896327 SURGEON'S GLOVES Productes Del Latex, S.A. KGO Class I 1989-11-08
K895354 INTRASITE CAVITY WOUND DRESSING Smith & Nephew United, Inc. KOZ Class I 1989-11-07
K895372 X-RAY DETECTABLE GAUZE SPONGE Keilei Intl., Inc. GDY Class I 1989-11-03
K895077 SURGICAL MASK/DENTAL MASK Ashton Medical Products, Inc. FXX Class II 1989-11-03
K895669 POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES Safeskin Corp. KGO Class I 1989-11-03

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