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General, Plastic Surgery

16,262 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
TUFFLEX POLYESTER SUTURE (K063194)Axya Medical, Inc.2006-12-04
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750)Boston Scientific Corp2006-12-04
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719)Laserscope2006-12-01
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK (K063012)Ncontact Surgical, Inc.2006-12-01
LOGIC LAPAROSCOPIC SCISSORS (K063485)Surgical Innovations Plc2006-12-01
NCONTACT COAGULATION SYSTEM KIT (K062539)Ncontact Surgical, Inc.2006-12-01
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S (K063013)Aearo Company2006-12-01
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, (K063025)Lina Medical Aps2006-12-01
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS (K063538)Arthrocare Corp.2006-12-01
REVLITE Q-SWITCHED ND:YAG LASER (K063112)Hoya Conbio, Inc.2006-12-01
EMG AC/DC SUCTION UNIT (K063448)Emg Technology Co., Ltd.2006-11-30
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM (K062589)Inolase 2002, Ltd.2006-11-30
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 (K063195)Valleylab2006-11-29
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER (K063141)Omniguide, Inc.2006-11-29
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP (K063060)Blueshine Srl2006-11-29
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL (K063435)W. L. Gore & Associates, Inc.2006-11-28
PROPATCH SOFT TISSUE REPAIR MATRIX (K061892)Cryolife, Inc.2006-11-22
GREENTON ECOLITE IPL SYSTEM (K062721)Greenton (London) , Ltd.2006-11-21
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 (K063178)C.R. Bard, Inc.2006-11-21
ONCOBIONIC SYSTEM (K060054)Oncobionics, Inc.2006-11-21
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (K063161)Leonhard Lang GmbH2006-11-21
MODIFICATION TO BIOMARC TISSUE MARKER (K063193)Carbon Medical Technologies, Inc.2006-11-21
M3 (K063333)Mavig GmbH2006-11-21
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 (K062822)Vascular Solutions, Inc.2006-11-21
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES (K061829)New Leaf Medical, Inc.2006-11-17
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 (K061375)Louis M. Gerson Co., Inc.2006-11-17
C-PORT DISTAL ANASTOMOSIS SYSTEM (K053524)Cardica, Inc.2006-11-16
DENLASER 800 PLUS (K062619)CAO Group, Inc.2006-11-14
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE (K062871)Lynton Lasers Limited2006-11-14
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 (K062441)Barrx Medical, Incorporated2006-11-14
HALO90 COAGULATION CATHETER (K062723)Barrx Medical, Incorporated2006-11-09
IRIDEX OCULIGHT TX (K062369)Iridex Corp2006-11-08
I-STOP TRANS OBTURATOR MALE SLING (K063079)Cl Medical2006-11-07
HEPATOSTAT SET, MODEL 760X (K061796)Vygon Corp.2006-11-02
HEM-O-LOK LIGATION CLIP (K062914)Teleflex Medical2006-11-02
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (K061288)United States Surgical, A Division of Tyco Healthc2006-11-02
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS (K063075)Power Medical Interventions, Inc.2006-11-02
MALE REMEEX SYSTEM (K062341)Specialities Remeex International, S.L.2006-11-02
SMARTLIPO ND:YAG LASER (K062321)Cynosure, Inc.2006-10-31
NEOTRACT ANCHOR (K061700)Neotract, Inc.2006-10-26
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K062665)Inovel, LLC2006-10-24
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC (K061878)E Surgical, LLC2006-10-24
THERMACLEAR (K060653)Dermacare, Inc.2006-10-24
BARD COMPOSITE L/P MESH (K061754)Davol Inc., Sub. C. R. Bard, Inc.2006-10-23
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (K062850)United States Surgical, A Division of Tyco Healthc2006-10-23
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE (K060414)Kmi Kolster Methods, Inc.2006-10-23
SUPERSTITCH 5F, 12F, AND EL (K062125)Sutura, Inc.2006-10-19
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE (K062336)Optimedica Corporation2006-10-19
ENSEAL PTC TISSUE SEATING SEALING DEVICE (K062949)Surgrx, Inc.2006-10-18
ENSEAL PTC TISSUE SEALING DEVICE (K063097)Surgrx, Inc.2006-10-18
AXIOM PULSED LIGHT SYSTEM (K062312)General Project S.R.L.2006-10-16
NOVASPINE POWERED SUCTION PUMP PRO-1 (K062456)Novaspine, LLC2006-10-16
POLARCOAT (K052907)Patton Surgical Corp.2006-10-16
HABIB 4X LAPAROSCOPIC (K062935)Rita Medical Systems2006-10-13
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT (K062697)Cook Biotech, Inc.2006-10-13
SURGISIS, SURGISIS ES (K062696)Cook Biotech, Inc.2006-10-13
STELLARTECH 100 COAGULATION SYSTEM (K061544)Stellartech Research Corp.2006-10-13
THERMASSAGE (K061001)Thermage, Inc.2006-10-12
CARDIOFLON, CARDIOXYL (K060163)Peters Surgical2006-10-11
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K062663)Moldex/Metric, Inc.2006-10-11
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE (K061660)Stryker Instruments2006-10-10
GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 (K061417)Genicon2006-10-10
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG (K062729)Cook Biotech, Inc.2006-10-10
STARION INSTRUMENTS THERMAL LITIGATING SHEARS (K062257)Starion Instruments2006-10-10
KMI CEMENT RESTRICTOR IMPLANT (K061465)Kinetikos Medical, Inc.2006-10-05
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES (K062047)PAJUNK GmbH Medizintechnologie2006-10-05
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR (K062337)Aaron Medical Industries2006-10-05
SMARTSUCTION SOLO DEVICE (K062801)Haemonetics Corp.2006-10-04
V.A.C. THERAPY SYSTEM (K062227)Kci USA, Inc. (Kinetic Concepts, Inc.)2006-10-04
OPTIME, SINUSORB PGA (K062366)Peters Surgical2006-10-02
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 (K062320)Cook Biotech, Inc.2006-10-02
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (K052870)Kimberly-Clark Corp.2006-09-29
MINI-YAG LASER (K061850)American Lasers, Inc.2006-09-29
PROMETEY, MODEL G1-03 (K062071)Spectrum International2006-09-28
CARE-E-VAC 3 (K062610)Ohio Medical Corporation2006-09-28
LITETOUCH DENTAL LASER SYSTEM (K061966)Light Instrument, Ltd.2006-09-27
TATTOOSTAR FAMILY (K060787)Asclepion Laser Technologies GmbH2006-09-27
COOLTOUCH, MODEL CTEV (K061618)New Star Lasers, Inc.2006-09-25
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 (K062210)New Star Lasers, Inc.2006-09-25
SURGICAL DRAPES (K061422)Austin Medical, Inc.2006-09-25
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES (K062072)PAJUNK GmbH Medizintechnologie2006-09-22
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM (K062423)Omniguide, Inc.2006-09-21
SURGI-WRAP MAST BIORESORBABLE SHEET (K061473)Mast Biosurgery USA, Inc.2006-09-21
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM (K061877)Boston Scientific Corp2006-09-15
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 (K061864)Dukal Corp.2006-09-15
SURGICAL HEADLIGHT (K061690)Gulf Medical Fiberoptics2006-09-15
ETHMOID SINUS SPACER (K062458)Acclarent, Inc.2006-09-15
STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS (K061225)Stryker Corp.2006-09-14
TORNIER CEMENT RESTRICTOR (K061824)Tornier2006-09-14
ENDOFAST RELIANT SYSTEM (K060329)Endogun Medical Systems2006-09-11
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE (K061835)Stryker Instruments2006-09-08
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM (K062048)Aesthera Corporation2006-09-07
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 (K061884)Bovie Medical2006-09-06
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE (K053540)Intermedic Arfran, SA2006-09-06
PORTRAIT PSR3 (K060948)Rhytec Incorporated2006-09-05
MSD BIPOLAR FORCEPS (K061635)Medtronic Sofamor Danek2006-09-05
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH (K061649)Power Medical Interventions, Inc.2006-09-01
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS (K062307)Anulex Technologies, Inc.2006-09-01
AXYAFLEX POLYESTER SUTURE (K060165)Axya Medical, Inc.2006-09-01
CRYOCARE CN2 SYSTEM (K062175)Endocare, Inc.2006-08-28
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