Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) (K131496)Bsn Medical, Inc.2013-07-10
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT (K130391)Boston Scientific Corp2013-07-10
FUSEFORCE IMPLANT SYSTEM (K124045)Solana Surgical, LLC2013-07-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) (K131331)Becton, Dickinson & CO2013-07-10
QDC-PRO, AND NOX-RIP (K124062)Nox Medical2013-07-10
AIGIS RX N MEDIUM; AIGIS RX N LARGE (K131007)Tyrx, Inc.2013-07-10
STATSEAL DISC (K130324)Biolife, LLC2013-07-09
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC (K131072)Coloplast A/S2013-07-09
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS (K130879)Nexus Medical, LLC2013-07-09
AMBIO REMOTE HEALTH MONITORING SYSTEM (K130676)Arrayent Health, LLC D/B/A Ambio Health2013-07-08
WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K131463)Honsun (Nantong) Co., Ltd.2013-07-08
SFI BAR ABUTMENTS (K130183)Sterngold Dental, LLC2013-07-07
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K131666)Maquet Cardiopulmonary, AG2013-07-05
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR (K131511)Changzhou Sinolinks Medical Innovation Co., Ltd.2013-07-05
CLICKFINE PEN NEEDLE (K131125)Ypsomed AG2013-07-05
MECTALIF (K131671)Medacta International2013-07-05
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K131078)STERIS Corporation2013-07-05
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES (K131283)Wrightmedicaltechnologyinc2013-07-05
ISUS IMPLANT SUPRASTRUCTURES (K122424)Dentsply International, Inc.2013-07-05
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) (K130473)Hartalega Sdn Bhd2013-07-05
ERMIS STERILIZATION CONTAINER SYSTEM (K123234)Ermis Medizintechnik2013-07-05
TIBURON SURGICAL DRAPE (K130404)Cardinal Health200, LLC2013-07-05
AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS (K130211)Spsmedical Supply Corp.2013-07-05
ETII SA FIXTURE SYSTEM (K123471)Hiossen, Inc.2013-07-05
CLICKFINE AUTOPROTECT PEN NEEDLE (K131123)Ypsomed AG2013-07-05
QUICK VUE INFLUENZA (K131599)Quidel Corporation2013-07-05
SOFIA INFLUENZA A+B FIA (K131606)Quidel Corp.2013-07-05
TRANSCORP ACIF SYSTEM (K121178)Transcorp, Inc.2013-07-05
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM (K131480)Emerge Medical2013-07-03
2MP COLOR LCD MONITOR, RADIFORCE MX215 (K131090)Eizo Corporation2013-07-03
CP150 ELECTROCARDIOGRAPH (K131573)Welch Allyn, Inc.2013-07-03
CYBER TM FAMILY (K131081)Quanta System Spa2013-07-03
DYNASTY ACETABULAR SYSTEM WITH CERAMIC (K130376)Wrightmedicaltechnologyinc2013-07-03
2008K@HOME HEMODIALYSIS MACHINE (K124035)Fresenius Medical Care North America2013-07-03
ARTHREX DISTAL RADIUS PLATE SYSTEM (K131474)Arthrex, Inc.2013-07-03
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH (K123641)Hertart2013-07-03
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM (K123177)Laserstim, Inc.2013-07-03
FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS (K123983)Qualigen, Inc.2013-07-03
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER (K131786)Airstrip Technologies, LP2013-07-03
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171)HORIBA ABX SAS2013-07-03
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC (K120977)International Technidyne Corp.2013-07-03
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS (K123074)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-07-03
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (K123256)The Binding Site Group , Ltd.2013-07-03
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (K130805)Menicon Co, Ltd.2013-07-03
ABSOCLEAR (K130553)Pharmaplast S.A.E.2013-07-03
IFUSION (K130656)Optovue, Inc.2013-07-03
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, (K131106)Canon, Inc.2013-07-03
NEWTOM VGI AND NEWTOM 5G (K130442)Qr S.R.L.2013-07-03
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) (K131670)Biomet, Inc.2013-07-03
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT (K131575)Exactech, Inc.2013-07-03
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K123803)Reverse Medical Corporation2013-07-02
AFFIX SPINOUS PROCESS PLATE SYSTEM (K131238)Nuvasive, Inc.2013-07-02
CORRECT PLUS 1 (K130920)Pentron Clinical2013-07-02
MOBIS II (K131372)Signus Medizintechnik GmbH2013-07-02
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA (K130935)Rayence Co., Ltd.2013-07-02
PROCELLERA (K130350)Vomaris Innovations, Inc.2013-07-02
BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER (K131401)Mercator Medsystems, Inc.2013-07-02
SENSUS (K130919)Neurometrix, Inc.2013-07-02
ARTHROCARE TURBINATOR WAND (K122652)ArthroCare Corporation2013-07-02
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM (K131035)Linvatec Corporation D/B/A Conmed Linvatec2013-07-02
VIDA PTV DILATATON CATHETER (K131002)C.R. Bard, Inc.2013-07-02
MDK MULTI-APPLICATIONS PLATFORM (K130256)Quanta System Spa2013-07-02
COOK HOLMIUM LASER FIBER (K124030)Cook Incorporated2013-07-01
CIRONA DVT FOOT GARMENT (K131743)Devon Medical, Inc.2013-07-01
ELLEX 2RT (K122202)Ellex Medical Pty, Ltd.2013-07-01
HEATER-COOLER UNIT HCU 40 (K130300)Maquet Cardiopulmonary, AG2013-07-01
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) (K130353)Pipeline Orthopedics2013-07-01
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY (K131705)Covidien, Formerly US Surgical A Divison of Tyco H2013-07-01
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT (K130408)Sterngold Dental, LLC2013-07-01
QUICKVUE INFLUENZA A+B (K131619)Quidel Corp.2013-06-28
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE (K130724)Straumann USA2013-06-28
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM (K123275)Phadia AB2013-06-28
SUDO PATH (K131568)Ld Technology, LLC2013-06-28
CODA BALLOON CATHETER (K122917)Cook, Inc.2013-06-28
SURECALL LABOR MONITOR (K130002)Reproductive Research Technologies, LP2013-06-28
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM (K130638)Philips Medical Systems Nederland B.V.2013-06-28
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS (K130808)Straumann USA2013-06-28
REVITIVE IX (K123354)Actegy , Ltd.2013-06-28
ET SMARTFIT ABUTMENT (K123627)Hiossen, Inc.2013-06-28
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM (K123559)Biotest Medical Corp.2013-06-28
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION (K123598)Smith & Nephew, Inc.2013-06-28
NIRVANA D PERSONAL LUBRICANT (TBD) (K123427)Church & Dwight Co., Inc.2013-06-28
ZOE FLUID STATUS MONITOR (K131509)Noninvasive Medical Technologies, Inc.2013-06-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) (K123404)Becton, Dickinson & CO2013-06-27
STREAMLINE TL SPINAL SYSTEM (K131100)Pioneer Surgical Technology, Inc.2013-06-27
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K130094)Abbott Diabetes Care2013-06-27
AXLE INTERSPINOUS FUSION SYSTEM (K130438)X-Spine Systems, Inc.2013-06-27
STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER (K131654)Senorx, Inc.2013-06-27
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) (K131683)Depuy Mitek, Inc., A Johnson and Johnson Company2013-06-27
KEELER SLIT LAMP H-SERIES (K131589)Keeler, Ltd.2013-06-27
EARPROBE (K131141)Path Medical GmbH2013-06-27
LYRIC2 (K130790)Phonak, LLC2013-06-27
LASERBRUSH (K121920)Sunetics International Marketing Group, LLC2013-06-27
HEMOCONCENTRATOR (K123288)Maquet Cardiopulmonary, AG2013-06-26
KSEA BIPOLAR ELECTRODE (K122983)KARL STORZ Endoscopy-America, Inc.2013-06-26
MONITOR B40 (K130584)Ge Medical Systems China Co., Ltd.2013-06-26
23GA CURVED ILLUMINATING LASER PROBE (K122997)Peregrine Surgical , Ltd.2013-06-26
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN (K123266)Becton, Dickinson and Company2013-06-26
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR (K130549)Carl Zeiss Meditec, Inc.2013-06-26
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES (K122653)Kimberly-Clark Corporation2013-06-26
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Every clearance here is in the API, with alerts when new ones post.