Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDISIZE GOLD HEATER AND BOOSTER (K070714)Medisize BV2007-04-30
EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM (K062538)Diacare Corp.2007-04-30
AESCULAP RESORBABLE PIN, MODEL FR735 (K070178)Aesculap Implant System, Inc.2007-04-30
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 (K062641)Avazzia, Inc.2007-04-30
3I OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341)Implant Innovations, Inc.2007-04-30
GLOBUS PREMIUM MUSCLE STIMULATOR (K061632)Domino S.R.L.2007-04-30
MESODERM (K061849)Aa Advanced Technology, Inc.2007-04-30
TWILIGHT FULL FACE MASK (K070321)Invacare Corp.2007-04-30
ZIRBLOCK (K070537)Cdl Technologies, Inc.2007-04-30
PRESSX ZR (K070772)Wieland Dental + Technik GmbH & Co. KG2007-04-30
EASY CURING PEN-STYLE LED CURING LIGHT (K063659)Dent Corp. Research & Development2007-04-30
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) (K070552)Dade Behring, Inc.2007-04-30
DELTACUT (APPARATUS AND CANNULA) (K063233)PAJUNK GmbH Medizintechnologie2007-04-30
IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) (K063328)Imc-Heart Way LLC2007-04-27
FRAXEL IV SR LASER SYSTEM (K063808)Reliant Technologies, Inc.2007-04-27
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783)Philips Medical Systems, Inc.2007-04-27
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (K063503)Mallinckrodt Inc., Liebel-Flarsheim Business2007-04-27
ARTHROCARE CAVITY SPINEWAND (K063172)Arthrocare Corp.2007-04-27
STRYKER TWIST DRILLS (K070876)Stryker Craniomaxillofacial2007-04-27
RUNTHROUGH NS (K063695)Terumo Medical Corp.2007-04-27
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES (K071019)Mesure Technology Co., Ltd.2007-04-27
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (K070512)Chf Solutions, Inc.2007-04-27
COOK MICROWIRE WIRE GUIDE (K070410)Cook, Inc.2007-04-27
FRAXEL III SR LASER SYSTEM AND ACCESSORIES (K063038)Reliant Technologies, Inc.2007-04-27
OSSEOSPEED 4.0S-6MM, MODEL 24619 (K063779)Astra Tech, Inc.2007-04-27
UNIVERSAL SURGICAL MESH, MODEL 100 (K070018)Generic Medical Device, Inc.2007-04-27
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K070867)Ino Therapeutics, LLC2007-04-27
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER (K071011)Braemar, Inc.2007-04-27
SAPHENEIA CLARITY (K063391)Sapheneia Commercial Products AB2007-04-26
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 (K070413)CAO Group, Inc.2007-04-26
PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). (K070664)Progeny, Inc.2007-04-26
MEROGEL INJECTABLE BIORESORBABLE STENT (K070886)Medtronic, Inc.2007-04-26
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H (K070249)Horiba Abx2007-04-26
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (K070292)Zimmer GmbH2007-04-26
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE (K063582)Zimmer, Inc.2007-04-26
HYPER SAL (K070498)Pari Innovative Manufacturers, Inc.2007-04-26
ZOLL E SERIES WITH SEE-THRU CPR (K070455)Zoll Medical Corporation, World Wide Headquarters2007-04-26
ECHOSTIM FACET TIP (K063380)Havel'S, Inc.2007-04-25
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION (K062332)Altaire Pharmaceuticals, Inc.2007-04-25
DICOMPACS, MODEL 5 (K070618)Oehm Und Rehbein GmbH2007-04-25
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X (K070848)Bio-Rad, Diagnostics Grp.2007-04-25
ARTHROCARE ENT PLASMA WAND (K070374)Arthrocare Corp.2007-04-25
FREEALGIN (K070700)Zhermack S.P.A.2007-04-25
NEWLIFE SCIENCES LLC, MODEL TMR (K070474)Newlife Sciences, LLC2007-04-25
HSINER NEBULIZER BOTTLE (K070948)Hsiner2007-04-25
THEKEN VU MESH VBR SYSTEM (K070381)Theken Spine, LLC2007-04-25
ZILOS-TK (K063636)Hamilton Thorne Biosciences2007-04-24
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 (K062834)Genoss Co., Ltd.2007-04-24
ENSEAL PTC TISSUE SEALING DEVICE (K070896)Surgrx, Inc.2007-04-24
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM (K070330)Avantis Medical Systems, Inc.2007-04-24
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 (K070311)Medtronic Vascular2007-04-24
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR (K070839)Terumo Cardiovascular Systems Corp.2007-04-24
OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE (K063286)Implant Innovations, Inc.2007-04-24
MODIFIED MERCY RETRIEVER, MODEL 90070 (K070521)Concentric Medical, Inc.2007-04-24
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N (K070222)Fresenius Medical Care North America2007-04-24
INCIRCLE BI-POLAR RF ABLATION SYSTEM (K070711)Rfa Medical, Inc.2007-04-24
ORION (K070231)Nidek Technologies Srl2007-04-24
C! (K070589)Transphoton Corporation2007-04-24
4S SPINAL SYSTEM (K063708)Taeyeon Medical Co., Ltd.2007-04-24
FX DETACHABLE COIL SYSTEM (K060747)Micro Therapeutics, Inc.2007-04-24
VISIO+CD VIEWER# KPSCDVE01 (K070606)Keosys Sas2007-04-24
RETROPAN CCD-TWAIN-USB (K070535)Video Dental Concepts, Inc.2007-04-24
BARD MALECOT AND PEZZER DRAINS (K070879)C.R. Bard, Inc.2007-04-24
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR (K070776)Quantel Medical2007-04-24
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 (K070398)Hospira, Inc.2007-04-24
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 (K070203)Inviro Medical Devices, Inc.2007-04-23
MEDILASER, MODEL 1000 (K063745)Laser Thera, LLC2007-04-23
MODIFICATION TO ARTHROCARE ARTHROWANDS (K070958)Arthrocare Corp.2007-04-23
DIAZYME CREATININE LIQUID REAGENTS ASSAY (K062105)Diazyme Laboratories2007-04-23
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C (K063766)Good Biotech Corp.2007-04-23
VV FLUORO 3D (K070106)Brainlab AG2007-04-23
QUICK VUE RSV TEST, MODELS 20193, 20199 (K070747)Quidel Corp.2007-04-23
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R (K063758)Teleflex Medical2007-04-23
ACCENT (K070004)Alma Lasers , Ltd.2007-04-23
RII INFRARED EAR THERMOMETER, MODEL TH01BN (K070976)Radiant Innovation, Inc.2007-04-20
TALKING TRACH (K062104)Engineered Medical Systems, Inc.2007-04-20
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (K070210)Ohmeda Medical2007-04-20
PATIENTGALLERY IMAGING SOFTWARE (K070954)Raster Builders, Inc.2007-04-20
XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY (K070082)Vertebration,Inc2007-04-20
EXICLIP EXCS-M (K070836)Clevex, Inc.2007-04-20
COOK CELECT VENA CAVA FILTER (K061815)William Cook Europe Aps2007-04-20
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 (K070022)Mis Implants Technologies , Ltd.2007-04-20
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (K070247)Ohmeda Medical2007-04-20
LEONE MONOIMPLANT FOR O-RING OVERDENTURE (K070483)Leone S.P.A.2007-04-19
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP (K061756)Shen Wei (Usa), Inc.2007-04-19
ORBITAL RECONSTRUCTIVE IMPLANT (K070130)Becker & Associates Consulting, Inc.2007-04-19
HORIZON SE (K070254)Mennen Medical , Ltd.2007-04-19
MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM (K070775)Globus Medical, Inc.2007-04-19
B-SCAN PLUS (K070943)Accutome Ultrasound, Inc.2007-04-19
SORBACT WOUND DRESSING (K063059)Abigo Medical AB2007-04-19
INTERPLATE VBR SYSTEM (K070316)Rsb Spine, LLC2007-04-19
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM (K070710)Biosensors International-USA2007-04-19
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 (K071007)Heartway Medical Products Co., Ltd.2007-04-19
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 (K070091)Cardinal Health, Inc.2007-04-18
KOREBALANCE (KINESTHETIC ABILITY TRAINER) (K070676)Sportkat, LLC2007-04-18
PRO OSTEON 500R (K063346)Ebi, L.P.2007-04-18
SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX (K070181)Sintea Biotech, Inc.2007-04-18
SMS MULTI GLUCOSE CONTROL, MODEL 2120049 (K070506)Medical Specialties Supply Co., Inc.2007-04-18
THE FUGO BLADE FOR DENTISTRY (K063468)Medisurg , Ltd.2007-04-18
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C (K070168)Aearo Company2007-04-18
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Every clearance here is in the API, with alerts when new ones post.