Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LAMINOPLASTY PLATING SYSTEM (K090354)Aesculap Implant System, Inc.2009-05-12
NMI PICC (K091261)Navilyst Medical, Inc.2009-05-12
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES (K083838)Fook Tin Technologies Limited2009-05-12
MONOBOND PLUS (K090826)Ivoclar Vivadent, Inc.2009-05-11
SOCKIT! AND MCMERLIN DERMAL WOUND GEL (K090092)Mcmerlin Dental Products LP2009-05-11
MULTI-CHANNEL LASER THERAPY SYSTEM (K082686)United Integrated Services Co., Ltd.2009-05-11
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V (K091113)Pride Mobility Products Corp.2009-05-11
PULPDENT MICRO-HYBRID COMPOSITE (K090391)Pulpdent Corporation2009-05-11
POWER DRIVE CHAIR, MODEL: TMM6 (K091043)Transmotion Medical, Inc.2009-05-11
FSC 2 (K090601)Schoelly Imaging, Inc.2009-05-11
REFINE LIFT SYSTEM (K083102)Alure Medical, Inc.2009-05-11
GRIND NO MORE VERSION 2 AND 3 (K091175)Ranir, LLC2009-05-08
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (K090338)Reprocessing Products Corp2009-05-08
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 (K081286)Dako North America, Inc.2009-05-08
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN (K083729)Aniara Diagnostica, LLC2009-05-08
SYNGO RT THERAPIST CONNECT (K090683)Siemens Medical Solutions USA, Inc.2009-05-08
CRANIAL IMAGE GUIDED SURGERY SYSTEM (K082060)Brainlab AG2009-05-08
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
ZIO PATCH, MODEL Z100 (K090363)iRhythm Technologies, Inc.2009-05-08
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K090864)Integra Radionics, Inc.2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
NUVASIVE LATERAL PLATE SYSTEM (K091071)Nuvasive, Inc.2009-05-08
FLEX-TENS (K090717)Emsi2009-05-08
ORTHOLOC 2.0/2.4 PLATE SYSTEM (K090692)Wrightmedicaltechnologyinc2009-05-08
NEUROPET (K091269)Photodetection Systems, Inc.2009-05-08
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) (K090513)Shandong Huayue Glove Co., Ltd.2009-05-08
ADVIA CENTAUR TSH3-ULTRA METHOD (K083844)Siemens Healthcare Diagnostics2009-05-08
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K083156)Giga-Drive Sdn, Bhd2009-05-08
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM (K090243)Respironics Inc., Sleep & Home Respiratory Group2009-05-08
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (K090078)Iop, Inc.2009-05-08
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (K091257)Medi-Globe Corporation2009-05-08
ACCUTORR V MONITOR, MODEL 0998-00-2000 (K091068)Datascope Corp., Patient Monitoring Division2009-05-08
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K090409)Bio-Rad Laboratories2009-05-08
PMT SUBDURAL CORTICAL ELECTRODES (K082474)Pmt Corp.2009-05-08
PROCERA IMPLANT BRIDGE OVERDENTURE (K090069)Nobel Biocare AB2009-05-07
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT (K082497)Intuitive Surgical, Inc.2009-05-07
INNOPORT LAPAROSCOPIC ACCESS DEVICE (K090677)Innovia, LLC2009-05-07
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152)Coloplast A/S2009-05-07
CIRCULATOR BOOT (K082134)Circulator Boot Corp.2009-05-07
SAFEFLO VENA CAVA FILTER (K081138)Rmt Medical Technilogies, Inc.2009-05-07
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC (K082834)Ellman Int'L, Inc.2009-05-07
HANSEN MEDICAL ARTISAN S CONTROL CATHETER (K090365)Hansen Medical, Inc.2009-05-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090691)Shijiazhuang Benestar Plastic Co., Ltd.2009-05-07
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC (K090428)Genesee Biomedical, Inc.2009-05-07
SPEQ ULTRASOUND SYSTEM (K090505)Signostics Pty, Ltd.2009-05-07
PAINMASTER MCT PATCH (K090042)Newmark, Inc.2009-05-06
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640)Gimmi GmbH2009-05-06
MIRAGE ECHO (K090490)Resmed Corp2009-05-06
HUMAN BETA-2 MICROGLOBULIN KIT (K083289)The Binding Site, Ltd.2009-05-06
PATHFAST D-DIMER (K072288)Mitsubishi Kagaku Iatron2009-05-06
MODIFICATION TO: PSS SYSTEM (K090033)Spinal USA2009-05-06
VONFLEX PUTTY (K091267)Vericom Co., Ltd.2009-05-06
LARIAT II SUTURE DELIVERY DEVICE (K090385)Sentreheart, Inc.2009-05-06
PARIETEX MONOFILAMENT POLYESTER MESH (K090858)Sofradim Production2009-05-06
HD GUIDE CATHETER (K090335)Concentric Medical, Inc.2009-05-06
ASTHMA MONITOR MODEL, AM1 (K090486)Cardinal Health Germany 234 GmbH2009-05-06
LASER TOUCHONE (K083822)Laser Health Technologies, LLC2009-05-06
LIGAFIX INTERFACE SCREW (K090994)Science For Biomaterials2009-05-06
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 (K083922)Micrus Endovascular Corporation2009-05-06
MATCHEDFLICKER (K090266)Eyeic Corporation2009-05-06
ELECSYS RUBELLA IGG CALCHECK (K090311)Roche Diagnostics2009-05-05
GE VENUE 40, MODEL 5324338 (K091164)Ge Medical Systems China Co., Ltd.2009-05-05
INCLUSIVE ZIRCONIA ABUTMENT BLANKS (K083480)Inclusive Dental Solutions2009-05-05
ORTHADAPT PR (K090288)Pegasus Biologics, Inc.2009-05-05
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 (K083291)Carl Zeiss Meditec, Inc.2009-05-05
CONMED AER DEFENSE SMOKE EVACUATOR (K091139)Conmed Corporation2009-05-05
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM (K091160)Broncus Technologies, Inc.2009-05-05
PANTHER REALART, MODEL 4.7 (K083502)Prowess, Inc.2009-05-05
GBS PNA FISH (K082612)Advandx, Inc.2009-05-05
NIO 2MP (MDNG-2121) (K091172)Barco N.V.2009-05-05
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM (K090024)Alexandria Research Technologies, LLC2009-05-04
LUME 2 SYSTEM, MODEL GA0005000 (K083733)Lumenis, Ltd.2009-05-04
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) (K090182)Nuclemed S.A.2009-05-04
PHILIPS M3001A MULTI MEASUREMENT SERVER (K090360)Philips Medizin Systeme Boblingen GmbH2009-05-04
FOOTPRINT MEDICAL SILICONE FEEDING TUBE (K090559)Footprint Medical2009-05-04
CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K090913)Spectranetics Corp.2009-05-04
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE (K091016)Surgical Devices, A Global Business Unit Covidien2009-05-04
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. (K090157)Wcm Waste & Compliance Management, Inc.2009-05-04
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY (K090870)Micro Therapeutics, Inc.2009-05-01
HS II SHORT FIXTURE SYSTEM (K083633)Osstem Implant Co., Ltd.2009-05-01
FLOWPICC CATHETER (K083920)Vasonova, Inc.2009-05-01
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (K081938)Genzyme Diagnostics P.E.I., Inc.2009-05-01
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K091146)Accuray, Inc.2009-05-01
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) (K090973)Terumo Corp.2009-05-01
MONTERIS MEDICAL AUTOLITT LASER PROBE (K081509)Monteris Medical,2009-05-01
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 (K090079)Progeny, Inc.2009-05-01
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM (K082529)Alatech Healthcare, LLC2009-05-01
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 (K082554)Kimberly-Clark Corp.2009-05-01
OEC 9900 ELITE (K082781)Ge Healthcare Surgery2009-05-01
GLUCODR AUTO SYSTEM (K083628)All Medicus Co., Ltd.2009-05-01
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM (K090371)STERIS Corporation2009-05-01
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 (K090849)Ev3, Inc.2009-05-01
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS (K080355)Elekta Instrument AB2009-05-01
AVANTE LEUCITE BLOCKS (K090684)Somerset Dental Products, Inc.2009-05-01
RESTEP DVY SYSTEM, MODEL RSP-101 (K090308)Stortford Medical, LLC2009-05-01
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K083088)Nanosphere, Inc.2009-05-01
BCI WW1030 PULSE OXIMETER (K083557)Smiths Medical Pm, Inc.2009-05-01
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G (K090261)Smiths Medical Asd, Inc.2009-05-01
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM (K091107)Hemostatix Medical Technologies, LLC2009-05-01
METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (K090127)Solana Surgical, LLC2009-05-01
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Every clearance here is in the API, with alerts when new ones post.