meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
28
Latest Decision
1995-10-04

Clearances · page 100 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953159 ERBOTOM ICC BIPOLAR Erbe USA, Inc. GEI Class II 1995-10-04
K952239 AUTO SUTURE* MODIFIED LINEAR STAPLER** United States Surgical, A Division of Tyco Healthc GDW Class II 1995-10-03
K952045 LMT 20 HH LASER SURGIVAL SYSTEM Laser Max Medical Technologies Corp. GEX Class II 1995-10-03
K953830 KENSORB Kentron Health Care, Inc. GDY Class I 1995-10-03
K952046 LMT 20 AA LASER SURGICAL SYSTEM Laser Max Medical Technologies Corp. GEX Class II 1995-10-03
K952047 LMT 40 AA LASER SURGICAL SYSTEM Laser Max Medical Technologies Corp. GEX Class II 1995-10-03
K950996 DORNIER THERMAFOCUS 360 FIBER Daimler-Benz Aerospace GEX Class II 1995-10-03
K952737 CALVITRON HAIR TRANSPLANT SYSTEM Medicamat S.A. GAH Class I 1995-10-03
K954056 UNIVERSAL PLUS ES S/I INSTRUMENT Conmedcorp GEI Class II 1995-09-29
K953953 DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF Deroyal Industries, Inc. KCY Class I 1995-09-29
K952759 TOWEL PACK Medcare Custom Packaging, Inc. KKX Class II 1995-09-29
K953446 AESCULAP BIPOLAR CORDS Aesculap, Inc. GEI Class II 1995-09-29
K953065 ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) Microquartz Medical, Inc. GEX Class II 1995-09-27
K952962 EZ-PERSONAL PROTECTION KIT Safetec of America, Inc. FXX Class II 1995-09-27
K945914 BIPOLAR GENERATOR MODEL 2352 Richard Wolf Medical Instruments Corp. GEI Class II 1995-09-26
K953420 SILK*SKIN SCAR TREATMENT Silk*Skin Care Co. MDA Class I 1995-09-26
K953577 BARD VISILEX MESH 3 X 6 Davol Inc., Sub. C. R. Bard, Inc. FTL Class II 1995-09-26
K952114 KOOL GARD SINGLES GOWN American Threshold Industries, Inc. FYC Class II 1995-09-25
K952115 BARRIER GOWN, KOOL-GARD BACKLESS GOWN American Threshold Industries, Inc. FYC Class II 1995-09-25
K954088 TELESCOPING PENEVAC I.C Medical, Inc. GEI Class II 1995-09-22
K953654 ORS-111 O.R. Solutions, Inc. KKX Class II 1995-09-22
K953082 ILIAC CREST BONE MARROW ASPIRATION NEEDLE Baxter Healthcare Corp GDM Class I 1995-09-22
K952796 ADVANCED LASER MULTILINE SYSTEM, ALY Advanced Laser Services Corp. GEX Class II 1995-09-18
K953433 MIDAS REX TELESCOPING SYSTEM Midas Rex Pneumatic Tools, Inc. GET Class I 1995-09-15
K953641 MAXXUS ORTHOPAEDIC SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1995-09-15
K953057 CYLINDRICAL SPONGE Medical Perspectives Corp. GDY Class I 1995-09-14
K953059 KITTNER DISSECTOR Medical Perspectives Corp. GDY Class I 1995-09-14
K953060 ROSEBUD DISSECTOR Medical Perspectives Corp. GDY Class I 1995-09-14
K953058 ROUND STICK SPONGES, FLAT STICK SPONGES Medical Perspectives Corp. GDY Class I 1995-09-14
K953062 CHERRY DISSECTOR Medical Perspectives Corp. GDY Class I 1995-09-14
K954122 TAKE-APART SCISSORS KARL STORZ Endoscopy-America, Inc. GEI Class II 1995-09-14
K953494 TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY Trimedyne, Inc. GEX Class II 1995-09-14
K952755 POWERSCULPTOR PROBES Cardiogenes GEX Class II 1995-09-14
K953087 CHERRY PIT DISSECTOR Medical Perspectives Corp. GDY Class I 1995-09-14
K953432 ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS Midas Rex Pneumatic Tools, Inc. GET Class I 1995-09-14
K953088 TRIANGULAR SPONGES Medical Perspectives Corp. GDY Class I 1995-09-14
K952973 THE TULIP MONO-POLAR CAUTERY SPATULA The Tulip Mfg. Co. GEI Class II 1995-09-11
K953962 FORCEPS Biopsys Medical, Inc. GEN Class I 1995-09-08
K953251 MERTEX-PLUS O.R./SURGEONS GOWN Mercana Industries , Ltd. FYA Class II 1995-09-05
K952116 COVER GOWN American Threshold Industries, Inc. FYC Class II 1995-09-05
K951908 REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE Regent Hospital Products KGO Class I 1995-09-01
K953933 MED-TECH LASER GAS MIXTURE Medical Technical Gases Inc.. GEX Class II 1995-09-01
K952706 SPIRIT RIDGE SILICONE CARVING BLOCK Spirit Ridge Technologies FZE Class II 1995-08-28
K952792 PADLESS ELECTROSURGICAL PENCIL Lca, Inc. GEI Class II 1995-08-28
K953074 MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM Luxar Corp. GEX Class II 1995-08-28
K952705 SPIRIT RIDGE NASAL IMPLANT Spirit Ridge Technologies FZE Class II 1995-08-28
K950825 AM-YAG American Lasers, Inc. GEX Class II 1995-08-28
K953015 SAFESKIN SUPRA Safeskin Corp. KGO Class I 1995-08-28
K952708 PECTORALIS IMPLANT Spirit Ridge Technologies FZE Class II 1995-08-28
K953174 MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY Microquartz Medical, Inc. GEX Class II 1995-08-28
K952707 SILICONE ELASTOMER MALAR IMPLANT Spirit Ridge Technologies FZE Class II 1995-08-28
K952993 SAFESKIN SUPRA Safeskin Corp. KGO Class I 1995-08-28
K952981 FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC Utah Medical Products, Inc. FYD Class II 1995-08-28
K944393 STRYKER STERI-SHIELD SURGICAL APPAREL Stryker Corp. FYA Class II 1995-08-28
K952709 PROTHESIS, CHIN, INTERNAL Spirit Ridge Technologies FZE Class II 1995-08-28
K952974 QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER) Microquartz Medical, Inc. GEX Class II 1995-08-28
K952554 SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM Schwartz Electro-Optics, Inc. GEX Class II 1995-08-28
K952303 SPLASH ASSIST Innovative Outsourcing Solutions LYU Class I 1995-08-24
K952945 AQUAFLO HYDROGEL WOUND DRESSING & PACKER Sherwood Medical Co. NAE Class I 1995-08-23
K953737 VL7600 REM PATIENT RETURN ELECTRODE Valleylab, Inc. GEI Class II 1995-08-23
K953132 UIMAT PUMP KARL STORZ Endoscopy-America, Inc. BTA Class II 1995-08-23
K953195 VALLEYLAB FORCE 300 Valleylab, Inc. GEI Class II 1995-08-21
K953007 EXCALIBUR PLUS ELECTROSURGICAL UNIT Aspen Laboratories, Inc. GEI Class II 1995-08-21
K945285 USSC MONOFILAMENT POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1995-08-21
K951729 MEDI - PUMP Thomas Industries BTA Class II 1995-08-21
K952677 MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL Porex Surgical, Inc. FWP Class II 1995-08-21
K953658 CORSSFIRE PLUS Cardiogenes GEX Class II 1995-08-21
K951520 USSC POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1995-08-21
K951623 TLC SURGICAL GOWNS Tlc Tech Lab Clothes, Inc. FYA Class II 1995-08-18
K945505 ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE Ganz Industries Sdn. Bhd. KGO Class I 1995-08-18
K952216 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2 Surgical Laser Technologies, Inc. GEX Class II 1995-08-18
K951474 TLC SURGICAL DRAPES Tlc Tech Lab Clothes, Inc. KKY Class II 1995-08-18
K950684 CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER Cynosure, Inc. GEX Class II 1995-08-16
K952110 ELMED THERMO-FLUX Elmed, Inc. GEI Class II 1995-08-14
K952698 ENDOCARE ELECTROSURGICAL HANDPIECE Cytocare, Inc. GEI Class II 1995-08-14
K953424 ECLIPSE 3200 Cardiogenes GEX Class II 1995-08-11
K950120 SMART PLUG Hgm, Inc. GEX Class II 1995-08-11
K953071 STRYKER COMMAND2 OFFICE CONSOLE Stryker Instruments JEA Class I 1995-08-08
K952118 ELMER Biological Technology Corp. GEX Class II 1995-08-07
K950493 PHOTODERM VL. Esc, Energy Systems Corp. GEX Class II 1995-08-07
K942200 ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS Thantex Specialties, Inc. LYU Class I 1995-08-07
K952241 PROTOUCH OVERGLOVE Cottrell, Ltd. MMP Class II 1995-08-07
K952546 SILON SILICONE TEXTILE COMPOSITE Bio Med Sciences, Inc. MDA Class I 1995-08-07
K953064 BIOACCESS MARROW HARVEST SYSTEM Bioaccess, Inc. GDM Class I 1995-08-07
K952636 MEDLITE LASER SYSTEM Continuum Biomedical, Inc. GEX Class II 1995-07-31
K944276 SLOAN STA-DRI BOOTLEG LEGGING Sloan Corp. LYU Class I 1995-07-31
K944118 SLOAN STA-DRI SURGICAL JUMPSUIT Sloan Corp. LYU Class I 1995-07-31
K945948 ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES Ampri Rubberware Industries Sdn Bhd KGO Class I 1995-07-31
K952103 AEROS ASPIRATOR Aeros Instruments, Inc. BTA Class II 1995-07-31
K952733 SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS Myriad Lase, Inc. GEX Class II 1995-07-31
K952203 OTOSILK Boston Medical Products, Inc. NAD Class I 1995-07-31
K952754 SACS, INDEPENDENT FIBER COOLANT SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1995-07-31
K944947 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS Boston Surgical Products, Inc. GEI Class II 1995-07-28
K952832 DISPOSABLE BIPOLAR ELECTRODE Neuro Navigational Corp. GEI Class II 1995-07-26
K952008 KARL STORZ DRILL KARL STORZ Endoscopy-America, Inc. GEY Class I 1995-07-26
K951984 WHITE KNIGHT SURGEON'S VEST White Knight Healthcare FYA Class II 1995-07-25
K951562 OMNIPULSE-MAX HOLMIUM LASER Trimedyne, Inc. GEX Class II 1995-07-21
K952049 TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM Tissue Technologies, Inc. GEX Class II 1995-07-21
K952813 SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1995-07-20
K952772 MEGABEAM ENDO-ENT PROBE Ceram Optec, Inc. GEX Class II 1995-07-17

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