Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MSA100 PEAK FLOW METER (K133975)Beijing M&B Electronic Instruments Co., Ltd.2014-10-03
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT (K141743)Radiology Solutions, LLC2014-10-03
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (K141139)Zoll Circulation2014-10-03
Viberect Penile Vibratory Stimulation Device (K142304)Reflexonic, LLC2014-10-03
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER (K140062)Fsc Laboratories, Inc.2014-10-03
FORUM GLAUCOMA WORKPLACE (K141297)Carl Zeiss Meditec, AG2014-10-03
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (K141502)Orthocon, Inc.2014-10-03
HyProCure II (K142534)Graham Medical Technologies, LLC Dba Gramedica2014-10-03
UGEO PT60A Diagnostic Ultrasound System (K142466)Samsung Medison Co., Ltd.2014-10-03
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (K140605)Dima Italia Srl2014-10-03
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) (K142536)Jvckenwood Corporation2014-10-03
FDR D-EVO FLAT PANEL DETECTOR SYSTEM (K141765)Fujifilm Medical Systems U.S.A, Inc.2014-10-03
CRANIOPLUG (K140309)Ossdsign AB2014-10-03
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM (K142442)Zimmer, Inc.2014-10-03
EMERGE MEDICAL IM NAIL SYSTEM (K141347)Emerge Medical2014-10-02
JUGGERKNOT MINI SOFT ANCHOR (K140908)Biomet Sports Medicine2014-10-02
PADI-LOCK (K141200)Padi-Lock, LLC2014-10-02
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System (K142302)Polymer Technology Systems, Inc.2014-10-02
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION (K141664)Rexam Healthcare2014-10-02
Varian Verification System (VVS) (K142268)Varian Medical Systems, Inc.2014-10-02
Electro Auricular Device (K140530)Navigant Consulting, Inc.2014-10-02
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) (K141542)Covidien, LLC2014-10-02
DIVERGENCE Anterior Cervical Fusion System (K142450)Medtronic Sofamor Danek USA, Inc.2014-10-01
EXPEDIUM Spine System/Synapse System (K142460)Johnson and Johnson2014-10-01
Barrx RFA Self Sizing Balloon Catheter (K142364)Covidien, LLC2014-10-01
INNESIS PEEK TL CAGE (K140577)Bk Meditech, Co., Ltd.2014-10-01
WAVELIGHT FS200 LASER SYSTEM (K141476)Alcon Research, Ltd. Dba Alcon Laboratories, Inc.2014-09-30
AER-O-SCOPE COLONOSCOPE SYSTEM (K141286)Gi View , Ltd.2014-09-30
CLAVEGUARD FREEDOM SURGICAL LIGHT (K142076)Dickson & Dickson Healthcare (Us), Inc.2014-09-30
PolyCatch Retrieval Device (K142258)Medi-Globe Corporation2014-09-30
COMP A-I-R (K141140)Omron Healthcare, Inc.2014-09-30
FUSE COLONOSCOPY SYSTEM (K141598)Endochoice, Inc.2014-09-30
ESOPHYX2 HD (K142113)Endogastric Solutions, Inc.2014-09-30
WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K141547)Reflow Medical2014-09-30
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE (K130450)Purna Bina Sdn Bhd2014-09-30
PROFLUORO FLUORIDE VARNISH (K141422)Pac-Dent International, Inc.2014-09-30
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) (K140371)Abbott Diabetes Care, Inc.2014-09-30
IMACOR ZURA EVO IMAGING SYSTEM (K142054)Imacor, Inc.2014-09-29
PRO-PICC WITH VALVE TECHNOLOGY (K141633)Medical Components, Inc.2014-09-29
Operating Room Light Handle Adapter (K142386)Litex Manufacturing, Inc.2014-09-29
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION (K141314)Spineart2014-09-29
HELICAL RIDGE PEEK INTERFERENCE SCREW (K141290)MedShape, Inc.2014-09-29
PROVOX FREEHANDS FLEXIVOICE (K141380)Atos Medical AB2014-09-26
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET (K141490)Varian Medical Systems, Inc.2014-09-26
PERFRACTION (K141800)Sun Nuclear Corporation2014-09-26
AERODR SYSTEM 2 (K141271)Konica Minolta, Inc.2014-09-26
CLYDESDALE(R) SPINAL SYSTEM (K133577)Medtronic Sofamor Danek USA, Inc.2014-09-26
I.T.S. Hand Locking Plates System - HLS (K142418)I.T.S. GmbH2014-09-26
SINGLE-SITE WRISTED NEEDLE DRIVER (K141075)Intuitive Surgical2014-09-26
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE (K141097)Touchstone International Medical Science Co., Ltd.2014-09-26
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE (K141113)Spacelabs Healthcare, Ltd.2014-09-26
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817)Osmunda Medical Device Consulting Co., Ltd.2014-09-26
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)Ge Medical Systems, LLC2014-09-26
STRYKER S2 DRILL (K141935)Stryker Corporation2014-09-26
PRO-LINK WEDGE SYSTEM (K141905)Life Spine2014-09-26
MEDLINE NEURO SPONGE (K140369)Medline Industries, Inc.2014-09-26
OPERA SWING (K140380)General Medical Merate S.P.A2014-09-26
HEMASORB Resorbable Hemostatic Bone Putty (K142339)Orthocon, LLC2014-09-26
ESOFLIP ES (K142000)Crospon, Ltd.2014-09-25
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (K141007)Demetech Corp.2014-09-25
Optima XR200amx, Optima XR220amx (K142383)Ge Medical Systems, LLC2014-09-25
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION (K133603)Philips Medical Systems2014-09-25
PTA BALLOON DILATATION CATHETER (K141150)Boston Scientific Corp2014-09-25
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K142408)Polymed Therapeutics, Inc.2014-09-25
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ (K140670)Ellipse A/S2014-09-25
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (K141897)Synthes USA Products, LLC2014-09-25
POLARIS SPINAL SYSTEM - HA COATED (K141804)Biomet Spine, LLC2014-09-25
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT (K140378)Omniguide, Inc.2014-09-25
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES (K141358)Mauna Kea Technologies2014-09-25
PHANTOM XL INSULATED DILATORS (K140088)Tedan Surgical Innovations, LLC2014-09-25
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (K142546)Spectranetics, Inc.2014-09-25
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (K140097)Applied Medical Technology, Inc.2014-09-24
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM (K141829)Ceragem Medisys, Inc.2014-09-24
Ultraverse 035 PTA Balloon Dilatation Catheter (K142261)Bard Peripheral Vascular, Inc.2014-09-24
REACH ACCESS TELEMEDICINE DOSE CALCULATOR (K142123)Reach Health, Inc.2014-09-24
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER (K133456)C.R. Bard, Inc.2014-09-24
LUCID LY (K140837)Bio-Med USA, Inc.2014-09-24
SMARTGRAFT 30 SYSTEM (K141591)Ingeneron, Inc.2014-09-24
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K132121)Nova Biomedical Corporation2014-09-24
Palomar Icon Aesthetic System (K142376)Cynosure, Inc.2014-09-24
CONCHASMART BREATHING CIRCUIT (K140556)Teleflex, Inc.2014-09-24
4WEB SPINAL IMPLANT PRODUCTS (K142112)4Web, Inc.2014-09-23
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL (K141103)Neoortho Produtos Ortopedicos S/A2014-09-23
BIOSPACE BODY COMPOSITION ANALYZER (K141483)Biospace Corporation Limited2014-09-23
STERILIZATION CASSETTE (K141616)Oticon Medical AB2014-09-23
OPTIO-C ANTERIOR CERVICAL SYSTEM (K141500)Zimmer Spine, Inc.2014-09-23
STARBRIGHT 5% SODIUM FLUORIDE VARNISH (K140349)Nanova Biomaterials, Inc.2014-09-22
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED (K140077)Albaad , Ltd.2014-09-22
T2CANDIDA AND T2DX INSTRUMENT (DEN140019)T2biosystems, Inc.2014-09-22
PICOSURE WORKSTATION (K140719)Cynosure, Inc.2014-09-22
SIMEX SUBGLOTTIC ASPIRATION SYSTEM (K141255)Simex Medizintechnik GmbH2014-09-22
Predicate III Guidewire (K142397)Lake Region Medical2014-09-19
XLR8 PLUS (XLR8+) (K141437)Genadyne Biotechnologies, Inc.2014-09-19
LONGBOW SPACER SYSTEM (K133717)Life Spine2014-09-19
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit (K140634)Devon Medical, Inc.2014-09-19
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER (K141453)Lightlab Imaging, Inc.2014-09-19
SURGIMAP (K141669)Nemaris, Inc.2014-09-19
ENDO SMART (K133298)Meta Biomed, Inc.2014-09-19
VANTAGE ELAN (K141472)Toshiba America Medical Systems, In.C2014-09-19
XENMATRIX AB SURGICAL GRAFT (K133223)C.R. Bard, Inc.2014-09-19
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Every clearance here is in the API, with alerts when new ones post.