Atlas FDA

2013

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

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RecordFirmDate
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 (K130748)Smith & Nephew, Inc.2013-08-04
RESTORELLE M, RESTORELLE XL (K132061)Coloplast Corp.2013-08-02
SOFIA(R) HCG FIA (K131166)Quidel Corp.2013-08-02
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (K121370)Vectec2013-08-02
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 (K123347)Normed Medizin-Technik GmbH2013-08-02
SOLUTIS (K130933)Quantel Medical2013-08-02
SIDEKICK AND USHER SUPPORT CATHETERS (K131493)C.R. Bard, Inc.2013-08-02
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (K131517)Medrad, Inc. / Bayer Medical Care, Inc.2013-08-02
BD FACS SAMPLE PREP ASSISTANT III (K131301)Becton, Dickinson & CO2013-08-02
INTELLISAVE AX700 ANESTHESIA SYSTEM (K122063)Philips Anesthesia Care2013-08-02
CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC (K131079)Creganna Medical Devices2013-08-01
AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING (K130345)Mayer Laboratories, Inc.2013-08-01
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE (K131305)Chison Medical Imaging Co., Ltd.2013-08-01
PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER (K130826)Stryker Endoscopy2013-08-01
CARDIO VISION MICS AORTIC CLAMPS (K123571)Cardiomedical GmbH2013-08-01
MYOVISION 3.0 WIREFREE SYSTEM (K123399)Precision Biometrics, Inc.2013-08-01
ENDOGRAPH DC (K130109)Villa Sistemi Medicali S.P.A.2013-08-01
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM (K130814)Depuy Mitek, A Johnson & Johnson Company2013-08-01
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO (K130033)Biomet Manufacturing Corp2013-08-01
INTRA-LOCK OP DENTAL IMPLANT (K130140)Intra-Lock International2013-08-01
VIAL CONNECTOR 13MM CLOSED COLLAR (K132040)Medimop Medical Projects, Ltd.2013-07-31
JBAIDS PLAGUE DETECTION KIT (K131729)Biofire Diagnostics, Inc.2013-07-31
NMI PICC III CATHETER, NMI HPICC III CATHETER (K131942)Navilyst Medical, Inc.2013-07-31
REXTAR X (K132041)Meta Biomed, Inc.2013-07-31
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) (K131754)Guangzhou Wondfo Biotech Co., Ltd.2013-07-31
ARTHREX SPEEDCINCH (K132043)Arthrex, Inc.2013-07-31
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (K123908)Matrix Surgical USA2013-07-31
JBAIDS TULAREMIA DETECTION KIT (K131936)Biofire Diagnostics, Inc.2013-07-31
5F DIGNITY CT TITANIUM PORT (K130923)Medical Components, Inc.2013-07-31
ABL90 FLEX (K130144)Radiometer Medical Aps2013-07-31
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K130181)Infopia Co, Ltd.2013-07-31
COALITION SPACER (K131449)Globus Medical, Inc.2013-07-30
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT (K130302)Spinevision S.A.2013-07-30
VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM (K122458)Cello Partnership D/B/A Verizon Wireless2013-07-30
MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM (K124000)Medapps Inc., Dba Alere Connect2013-07-30
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS (K130949)Biomet 3i2013-07-30
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP (K132008)Medtronic, Inc.2013-07-30
BROADMASTER HEALTHCARE SYSTEM (K130621)Broadmaster Biotech Corporation2013-07-30
NEUROBLATE(TM) SYSTEM (K131955)Monteris Medical, Inc.2013-07-30
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES (K122532)Intuitive Surgical, Inc.2013-07-30
CURA COMPENSATOR (K131150)Cura Medical Technologies, LLC2013-07-30
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) (DEN130010)Abbott Molecular, Inc.2013-07-29
WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET (K131361)Covidien2013-07-29
PTFE SUPER SHEATH INTRODUCER (K130855)Martech Medical Products2013-07-29
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP (K130059)Ibi Israel Biomedical Innovations , Ltd.2013-07-29
ANGIOJET ULTRA POWER PULSE KIT (K130381)Medrad, Inc.2013-07-29
MERIT HYDROPHILIC GUIDE WIRE (K131710)Merit Medical Systems, Inc.2013-07-29
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY (K122091)Cook, Inc.2013-07-29
OPHTACATH KIT (K123831)France Chirurgae Instrumentation2013-07-29
MULTIFIX S KNOTLESS FIXATION DEVICE (K131182)Arthocare Corporation2013-07-29
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS (K130680)Dentsoll, Inc.2013-07-26
ZIRMON SERIES (K131117)Kuwotech Co., Ltd.2013-07-26
KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS (K131264)Gebr. Brasseler GmbH & Co. KG2013-07-26
TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445)Beckman Coulter, Inc.2013-07-26
HBA1C CONTROL, LEVEL 1 AND LEVEL 2 (K131999)Randox Laboratories, Ltd.2013-07-26
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION (K131448)Koelis2013-07-26
GMK REVISION EXTENSION (K123721)Medacta International2013-07-26
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331)Sauflon Pharmaceuticals, Ltd.2013-07-26
CHEMOLOCK, CHEMOLOCK PORT (K131549)Icu Medical, Inc.2013-07-26
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS (K130478)Globus Medical, Inc.2013-07-26
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST (K131931)Chemtron Biotech, Inc.2013-07-26
RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (K123768)STERIS Corporation2013-07-26
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER (K131814)Ameco Medical Industries2013-07-26
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500)Sebia2013-07-26
BARRX CHANNEL RFA ENDOSCOPIC CATHETER (K130623)Covidien, LLC2013-07-26
SEER 1000 (K130785)Getemed Medizin- Und Informationstechnik AG2013-07-26
DENTAL UNIT WITH CHAIR (K130410)Xianyang North West Medical Instrument (Group) Co.2013-07-26
EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (K131595)Eurotrol B.V.2013-07-26
VDRIVE W/V-SONO (K122659)Stereotaxis, Inc.2013-07-26
CARE SU01A SUCTION ASPIRATOR (K130001)Foshan Care Medical Technology Co., Ltd.2013-07-25
JONES-FX FRACTURE SYSTEM (K131620)Instratek, Inc.2013-07-25
SENSIS, SENSIS LITE (K131812)Siemens Medi Cal Solutions, Inc.2013-07-25
BARRICADE EMBOLIZATION COIL SYSTEM (K131475)Blockade Medical2013-07-25
HAMMERTOE CORRECTION SYSTEM (K130859)Arthrosurface, Inc.2013-07-25
XPERT MTB/RIF ASSAY (DEN130032)Cepheid2013-07-25
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) (K131974)Depuy Mitek, A Johnson & Johnson Company2013-07-25
CAPSTONE(R) SPINAL SYSTEM (K123027)Medtronic Sofamor Danek, Inc.2013-07-25
DUOFLEX COIL SUITE (1.5T) (K130706)Mr Instruments, Inc.2013-07-25
M-SCAN (K130158)Bio-Research Associates, Inc.2013-07-25
IQQA-LIVER MULTIMODALITY SOFTWARE (K131498)Edda Technology, Inc.2013-07-25
SMARTRELIEF (K131159)Chattem, Inc.2013-07-25
COMPRESSYN BAND (K130431)Dallen Medical, Inc.2013-07-25
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (K131964)Medtronic, Inc.2013-07-24
R&D 5D RETIC HEMATOLOGY CONTROL (K130962)R&D Systems, Inc.2013-07-24
XPERGUIDE (K131263)Philips Medical Systems Nederland B.V.2013-07-24
EDWARDS EMBOL-X INTRODUCER SHEATH (K123714)Edwards Lifesciences, LLC2013-07-24
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (K130305)Lina Medical Aps2013-07-24
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K131690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2013-07-24
SAM JUNCTIONAL TOURNIQUET (K131561)Sam Medical Products2013-07-24
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL (K130667)Preventive Care, Inc.2013-07-24
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC (K131542)Novabay Pharmaceuticals, Inc.2013-07-24
REFORM PEDICLE SCREW SYSTEM (K131343)Spinal USA2013-07-24
HEM-6131 (K131742)Omron Healthcare, Inc.2013-07-24
MTA CEMENTS (K130125)S&C Polymer Silicon- Und Composite Spezialitaeten2013-07-24
PERCUNAV SYSTEM (K132087)Philips Health Care2013-07-24
FRAG-LOC SYSTEM (K130986)Acumed, LLC2013-07-23
ESIE APPS SUITE (K132062)Siemens Medical Solutions USA, Inc.2013-07-23
SPACELABS HEALTHCARE CARDIOEXPRESS (K130207)Spacelabs Healthcare, Ltd.2013-07-23
SHARPSCAN (K123807)Medical Engineering Development Solutions, Inc.2013-07-23
SORIN CONNECT DATA MANAGEMENT SYSTEM (K131816)Sorin Group Deutschland GmbH2013-07-23
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Every clearance here is in the API, with alerts when new ones post.