meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
46
Latest Decision
1991-07-19

Clearances · page 120 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K905802 CENTAURI/PEGASUS Pfizer Laser Systems GEX Class II 1991-07-19
K911787 MONOPOLAR SPHINCTERTOME Everest Medical Corp. GEI Class II 1991-07-19
K911997 TENDERFOOT(R), MODIFICATION International Technidyne Corp. FMK Class II 1991-07-17
K912438 MODELS 5,8,20,20S ARGON ION LASERS Hgm Medical Laser Systems, Inc. GEX Class II 1991-07-17
K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK Tecnol New Jersey Wound Care, Inc. FXX Class II 1991-07-12
K911134 SURGICAL GLOVES Kenwell International , Ltd. KGO Class I 1991-07-12
K904632 CENTAURI YAG LASER SYST, GYNECOLOGY Pfizer Laser Systems GEX Class II 1991-07-11
K903174 ADVANCE SUTURE ABSORBABLE GUT SUTURE Advance Suture, Inc. GAE Class I 1991-07-10
K911606 BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES Baxter Healthcare Corp KDD Class I 1991-07-09
K912651 AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM Stackhouse Assoc. FYD Class II 1991-07-08
K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS Tecnol New Jersey Wound Care, Inc. FXX Class II 1991-07-08
K911407 HARDING STERNAL SHIELD Harding Medical Devices EYF Class I 1991-07-05
K911929 SMALL BONE FIXATION SYSTEM United American Medical Co., Inc. HWE Class I 1991-07-02
K911476 LAPAROSCOPIC ELECTRODE WITH LAVAGE AND SUCTION United States Endoscopy Group, Inc. GEI Class II 1991-07-02
K911491 LAPAROSCOPIC ELECTRODE United States Endoscopy Group, Inc. GEI Class II 1991-07-02
K911905 DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED Deknatel, Inc. GAW Class II 1991-07-02
K911930 STERILE PACKAGED POWER INSTRUMENT ACCESSORIES United American Medical Co., Inc. HWE Class I 1991-07-02
K910074 LAPAROMED HOOK/SPATULA DEVICE Laparomed Corp. GEI Class II 1991-07-02
K911515 EXTENDED MALAR IMPLANT Implantech Associates, Inc. LZK Class II 1991-07-01
K911514 ARTICULATED CHIN IMPLANT Implantech Associates, Inc. FWP Class II 1991-07-01
K911516 HIGH PROFILE CHIN IMPLANT Implantech Associates, Inc. FWP Class II 1991-07-01
K911513 TRAPEZOIDAL MALAR IMPLANT Implantech Associates, Inc. LZK Class II 1991-07-01
K903176 ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE Advance Suture, Inc. GAW Class II 1991-06-28
K905454 ADVANCE SUTURE NONABSORBABLE SILK SUTURE Advance Suture, Inc. GAP Class II 1991-06-28
K903177 ADVANCE SUTURE NONABSORBABLE NYLON SUTURE Advance Suture, Inc. GAR Class II 1991-06-28
K910939 COOK TISSUE MORCELLATOR Cook Urological, Inc. GEI Class II 1991-06-28
K911420 HISTOFREEZER Solarcare Technologies Corp,Inc. GEH Class II 1991-06-28
K911150 SOREX SAFE-AIR Sorex Medical GEX Class II 1991-06-28
K911338 LIMA CEMENT RESTRICTOR Turnkey Intergration USA, Inc. JDK Class II 1991-06-28
K910890 NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER Lovell-Schenck, Inc. LYU Class I 1991-06-27
K912252 INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT Fiberoptic Medical Products, Inc. FST Class II 1991-06-27
K911341 HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO Ultracision, Inc. GEI Class II 1991-06-24
K895363 BIOVISION EMERALD LASER PHOTOCOAGULATOR F.I.T. of France GEX Class II 1991-06-24
K911353 EMC MODEL NO. STATOME 900 Emc Industries HAM Class II 1991-06-24
K910602 HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY Hgm Medical Laser Systems, Inc. GEX Class II 1991-06-24
K903418 LATERALASE TM Trimedyne, Inc. GEX Class II 1991-06-24
K911262 DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER ETHICON, Inc. GEA Class I 1991-06-20
K911274 UNIPOLAR COAGULATOR PROBE SYSTEM American Surgical Instruments Corp. GEI Class II 1991-06-20
K904631 CENTAURI YAG LASER SYST, NEUROSURGERY Pfizer Laser Systems GEX Class II 1991-06-18
K905383 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY Micro Surgical Instruments Corp. GEY Class I 1991-06-18
K911508 MAGNA SURGEONS GOWNS Dms Miami, Inc. FYA Class II 1991-06-17
K911509 MAGNA OBSTETRICAL PACKS Dms Miami, Inc. KKX Class II 1991-06-17
K911510 MAGNA SURGICAL PACKS Dms Miami, Inc. KKX Class II 1991-06-17
K905737 CENTAURI/PEGASUS Pfizer Laser Systems GEX Class II 1991-06-17
K911268 SURGICAL RUBBER GLOVES Pacificlink Export KGO Class I 1991-06-13
K910928 RUBBER LATEX SURGEONS GLOVES Regent Hospital Products KGO Class I 1991-06-13
K911365 ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS Northgate Technologies, Inc. GEI Class II 1991-06-11
K910942 AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT Mdt Biologic Co. FSS Class II 1991-06-11
K911742 OP-D-OP VISOR SHIELDS Op-D-Op, Inc. LYU Class I 1991-06-07
K911852 COMPULSE CO2 SURGICAL LASER SYS. Laser Engineering, Inc. GEX Class II 1991-06-07
K911408 CROSSFIRE LASER ASSISTED ASPIRATION CANNULA Heraeus Lasersonics, Inc. GEX Class II 1991-06-03
K911040 INVOTEC MICROSCOPE DRAPE Invotec International, Inc. HMW Class II 1991-06-03
K911163 IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS Imagyn Medical, Inc. FWF Class I 1991-06-03
K910898 SURGICA(TM) H Hgm Medical Laser Systems, Inc. GEX Class II 1991-05-31
K910570 SPLINTER TWEEZERS Solan Scissors Sales FSM Class I 1991-05-31
K910831 ENDOPATH SURGICAL INSTRUMENTS Symbiosis Corp. GEI Class II 1991-05-31
K910767 TL100W/01 UVB LAMP Philips Lighting Co. FTC Class II 1991-05-23
K910712 VILLAN (VIDEO LIFT LINK ANALYSIS) Physio Systems, Inc. LXI Class I 1991-05-21
K905803 HALE SUN SURGICAL TOWEL OR O.R. TOWEL Hale Sun Industries, Ltd. KKX Class II 1991-05-21
K910491 WALLACH COLD SOAKER Wallach Surgical Devices, Inc. GEH Class II 1991-05-21
K910736 JACKSON MULTIPURPOSE OPERATING TABLE Orthopedic Systems, Inc. JEA Class I 1991-05-21
K911601 REDDICK TROCAR AND CANNULA Ideal Medical, Inc. FSM Class I 1991-05-21
K910920 PROTEKT GLOVES Intermedics Orthopedics FYE Class I 1991-05-15
K911913 PRECISION GLIDE - ENHANCED SURGICAL BLADE Bd Becton Dickinson Vacutainer Systems Preanalytic GES Class I 1991-05-13
K911921 DISPOSABLE ISOLATION GOWN Liaoning-Usa Corp. FYB Class II 1991-05-13
K911369 QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER Deroyal Industries, Inc. MDM Class I 1991-05-13
K911039 INVOTEC EAR DRAPE Invotec International, Inc. KKX Class II 1991-05-13
K910941 LIFELINER SURGICAL GLOVE Depuy-Raynham FYE Class I 1991-05-09
K910663 BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR Mdt Corp., Inc. GEI Class II 1991-05-09
K910200 LASER-35 Endo Technic Corp. GEX Class II 1991-05-09
K911204 QUALTEX SKIN STAPLE EXTRACTOR Deroyal Industries, Inc. GDT Class I 1991-05-08
K911895 QUALTEX SUTURE BOOTIES Deroyal Industries, Inc. MDM Class I 1991-05-08
K910067 PTI STERNAL CLOSURE WIRE SUTURE Pioneering Technologies, Inc. GAQ Class II 1991-05-06
K910515 FREEDOM MARK III SURGICAL HELMET SYSTEM Stackhouse Assoc. FYA Class II 1991-05-06
K911132 MULTIPLE, SURGICAL DRAPE PACK Central Georgia Ancillary Health Systems FZI Class II 1991-05-06
K910496 CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. Heraeus Lasersonics, Inc. GEX Class II 1991-05-06
K911160 MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 Mentor O & O, Inc. GEI Class II 1991-05-02
K910557 BARRIER* EXTRA PROTECTION PLUS FACE MASK Johnson & Johnson Medical, Inc. FXX Class II 1991-04-29
K911522 ARTHROBOT(TM) WRIST HOLDER ACCESSORY Andronic Devices, Ltd. JEA Class I 1991-04-29
K911316 INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA Northgate Technologies, Inc. GEI Class II 1991-04-29
K911245 EUDERMIC SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1991-04-25
K910410 SURGICAL GOWNS, EXTRA-LARGE SIZE Dawn of Hope Development Center FYC Class II 1991-04-25
K910779 DISPOSABLE ELECTROSURGICAL BLADE Conmedcorp GEI Class II 1991-04-25
K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE Internacional Farmaceutica, S.A. DE C.V. GAW Class II 1991-04-25
K904505 CCI CORNEAL SCARIFIER Buckman Co., Inc. GDX Class I 1991-04-23
K910245 I/A HANDPIECE WITH REPLACEABLE TIPS Surgical Technologies, Inc. GBX Class I 1991-04-22
K911568 GOWN, OPERATING SURGICAL Huntsville Rehabilitation Foundation FYA Class II 1991-04-22
K911523 MODIFICATION TO MODEL 90-1460 LASER ADAPTER Lifestream Int'L, Inc. GEX Class II 1991-04-22
K910510 VALLEY FORGE BIPOLAR PEN OR FORCEPS Valley Forge Scientific Corp. GEI Class II 1991-04-22
K910894 HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS Heraeus Lasersonics, Inc. GEX Class II 1991-04-22
K905676 MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH Laser Engineering, Inc. GEX Class II 1991-04-22
K904616 STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR Storz Instrument Co. HBI Class II 1991-04-19
K911377 FORCEPS, COAGULATION, BIPOLAR, MALIS International Hospital Supply Co. GEI Class II 1991-04-19
K904841 LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED Laser Photonics, Inc. GEX Class II 1991-04-19
K911225 TRAY DOUGH The Hygenic Corp. KGS Class I 1991-04-17
K910816 IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE Insight International, Inc. KDD Class I 1991-04-17
K904068 LUXAR MODEL LX-20 CO2 LASER Luxar Corp. GEX Class II 1991-04-15
K910167 MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM Microbio-Medics, Inc. GCY Class I 1991-04-15
K905206 INCARE PINSITE DRESSING Hollister, Inc. KOZ Class I 1991-04-12
K910857 ALLDRESS MULTI LAYERED WOUND DRESSING Scott Health Care NAB Class I 1991-04-12

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