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General, Plastic Surgery

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

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RecordFirmDate
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) (K101598)Exact Medical Manufacturing, Inc.2010-10-04
AIM 200, MAJOR SURGICAL LIGHT (K101537)Burton Medical Products Corp.2010-09-30
FAT CONCENTRATION SYSTEM (K100114)Biomet, Inc.2010-09-29
CRYOBALLOON ABLATION SYSTEM (K101825)C2 Therapeutics2010-09-29
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS (K102716)Alma Lasers, Inc.2010-09-28
DOCTOR SURGERY DIODE LASERS FAMILY (K102036)Lambda S.P.A.2010-09-28
ATEK SURGICAL GOWNS (K100971)Hangzhou Atek Medical & Textile Co., Ltd.2010-09-27
ISOLED AC-POWERED LED HEADLIGHT SYSTEM (K102266)Isolux, LLC2010-09-24
AFFIRM DO DIODE LASER (K101601)Cynosure, Inc.2010-09-23
ACCUSCULPT II LASER SYSTEM (K101573)Lutronic Corporation2010-09-23
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (K101688)Exact Medical Manufacturing, Inc.2010-09-20
E-LIGHT LINE (K092734)Espansione Marketing S.P.A2010-09-20
EMM EQUIPMENT COVER-POLYTHYLENE (K101689)Exact Medical Manufacturing, Inc.2010-09-20
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U (K100657)Kci USA, Inc. (Kinetic Concepts, Inc.)2010-09-17
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (K101366)Chromogenex Technologies, Ltd.2010-09-17
CO2 LASER SYSTEM (K101555)Advanced Technology Laser Co., Ltd.2010-09-17
BABY QUASAR (K091467)Silver Bay, LLC2010-09-17
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT (K100787)Smith & Nephew, Inc.2010-09-17
PROPATCH SOFT TISSUE REPAIR MATRIX (K101587)Cryolife, Inc.2010-09-16
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY (K102291)Covidien2010-09-15
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM (K100726)Biolitec, Inc.2010-09-15
CABLECAP MODEL: WLF, STZ, ACM (K101496)Sensormed2010-09-14
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 (K102173)Moldex/Metric, Inc.2010-09-13
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE (K101783)New Star Lasers, Inc.2010-09-13
STLASE DIODE LASER (K094049)Dental Photonics, Inc.2010-09-10
SURGICAL FACE MASK (K093901)Epard Protective Products, Ltd.2010-09-10
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US (K101490)Thermage, Inc.2010-09-08
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE (K102368)Ellman Int'L, Inc.2010-09-07
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL (K101593)Exact Medical Manufacturing, Inc.2010-09-03
CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 (K091125)Verilux2010-09-03
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES (K101506)Palomar Medical Technologies, Inc.2010-09-01
TEPHAFLEX COMPOSITE MESH (K101287)Tepha, Inc.2010-08-30
SUR-G GLOV AND MAXITEX (K102119)Terang Nusa Sdn Bhd2010-08-27
QUASAR BLUE LIGHT THERAPY SYSTEM (K093963)Silver Bay, LLC2010-08-27
SURGIMAX/ SURGIMAX PLUS (K100390)Elliquence, LLC2010-08-25
ZELTIQ AESTHETICS DERMAL COOLING DEVICE (DEN090002)Zeltiq Aesthetics2010-08-24
ERCHONIA ML SCANNER (MLS) (DEN090008)Erchonia Medical2010-08-24
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 (K093622)Encision, Inc.2010-08-20
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 (K101152)Focus Medical, LLC2010-08-18
IMC SURGICAL FACE MASK (K100846)International Medsurg Connection2010-08-16
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH (K101462)Caldera Medical, Inc.2010-08-16
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE (K100098)Jm System Co., Ltd.2010-08-13
PILOT DIODE LASER, MODEL 002-00139 (K100143)CAO Group, Inc.2010-08-13
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX (K100786)Bsd Medical Corp.2010-08-13
NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' (K101967)Ellman Int'L, Inc.2010-08-12
WATERLASE MD TURBO PLUS MODEL 7200XXX (K101658)Biolase Technology, Inc.2010-08-11
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 (K091310)Dfine, Inc.2010-08-11
WELLMIEN SURGICAL MASK (K101000)Wellmien (Suzhou) Import & Export Trading Co., Ltd.2010-08-09
ENDOSCOPIC CLIP SYSTEM (K102081)Aesculap, Inc.2010-08-06
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY (K102001)Smith & Nephew, Inc.2010-08-06
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I (K094021)Microsulis Medical Limited2010-08-06
TISSU TRANS FILTRON SYRINGE FILL (K102117)Shippert Medical Technologies Corp.2010-08-06
NEOTRACT ANCHOR SYSTEM MODEL TAS400 (K102028)Neotract, Inc.2010-08-04
ARTHREX BIOWIRE (K091018)Arthrex, Inc.2010-07-30
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 (K102050)Advanced Technology Laser Co., Ltd.2010-07-29
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 (K101276)Chemence Medical Products, Inc.2010-07-28
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 (K100543)Medisiss2010-07-23
QUANTA DIODE LASER SYSTEM (K100558)Quanta System Spa2010-07-22
SUPRA SCAN DELIVERY SYSTEM (K100678)Quantel Medical2010-07-21
NES REPROCESSED VARICOSE VEIN RF CATHETER (K090661)Northeast Scientific, Inc.2010-07-21
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS (K100702)Huot Instruments, LLC2010-07-20
LASEMAR 800, 1000, 1500 (K092860)Eufoton S.R.L.2010-07-16
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES (K101108)Erbe USA, Inc.2010-07-16
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE (K101102)Best Putra Gloves Sdn Bhd2010-07-16
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 (K101103)Best Putra Gloves Sdn Bhd2010-07-16
VENTRALIGHT ST MESH (K101851)Davol Inc., Sub. C. R. Bard, Inc.2010-07-15
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 (K101252)Neotract, Inc.2010-07-15
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) (K093179)H&H Research Company2010-07-14
AESCULAP MONOMAX ABSORBABLE SUTURE (K100876)Aesculap, Inc.2010-07-14
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT (K100461)Riverpoint Medical2010-07-08
HM-LAMP II (K100234)Hillusa, Inc.2010-07-08
THERACLEAR (K101415)Theravant Corporation2010-07-08
KMD-MARK1 TISSUE MARKER (K093473)Kent Medical Devices, Inc.2010-07-02
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC (K101190)Led Intellectual Properties, LLC2010-07-01
GYNECARE TVT ABBREVO CONTINENCE SYSTEM (K100936)ETHICON, Inc.2010-07-01
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 (K100816)Gyrus Acmi, Inc.2010-07-01
CERULEAU ELECTROSURGICAL PROBE (K101711)Nuortho Surgical, Inc.2010-07-01
HANSON MEDICAL FACIAL IMPLANTS (K090803)Hanson Medical, Inc.2010-06-30
LIPCOLLECTOR II (K101713)Human Med AG2010-06-29
FRANKENMAN SURGICAL STAPLERS (K101378)Suzhou Frankenman Medical Equipment Co., Ltd.2010-06-29
A4-XLR8 FOAM DRESSING (K092992)Genadyne Biotechnologies, Inc.2010-06-29
STRYKER KNIFELIGHT (K100884)Howmedica Osteonics Corp.2010-06-25
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 (K093196)Cousin Biotech Sas2010-06-25
CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 (K101018)Cardica, Inc.2010-06-25
SURGIMESH XD (K092233)Aspide Medical2010-06-25
STRYKER BIPOLAR FORCEPS (K093108)Stryker Leibinger GmbH & Co KG2010-06-22
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (K100388)Medical Illumination International, Inc.2010-06-22
NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX (K101080)Egon Faulhaber Surgical Instruments Pinzetten2010-06-21
FIAB SPA, MODELS F7244, F7233, F7234, F7277 (K100333)Fiab Spa2010-06-21
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 (K101440)Generic Medical Devices, Inc.2010-06-18
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 (K100638)Depuy Mitek, A Johnson & Johnson Company2010-06-18
MULTIFUNCTIONAL LINEAR PEN (K100501)AtriCure, Inc.2010-06-18
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 (K101111)Barrx Medical, Inc.2010-06-18
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E (K093619)Cook Ireland, Ltd.2010-06-17
PATCHASSIST (K101218)Polytouch Medical, Ltd.2010-06-17
GYRUS ACMI HALO PKS CUTTING FORCEPS (K100896)Gyrus Acmi, Inc.2010-06-17
CHEVEUX DIODE LASER SYSTEM (K100893)Sandstone Medical Technologies, LLC2010-06-16
CRYOCARE CS SURGICAL SYSTEM (K101333)Endocare, Inc.2010-06-14
TIDI FACEMASK (K100800)Tidi Products,Llc2010-06-14
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY (K101444)Surgical Devices, A Global Business Unit Tyco2010-06-14
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