Atlas FDA

2014

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

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RecordFirmDate
MACH LED 2SC (K140460)Dr. Mach GmbH & Co. KG2014-04-03
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE (K133914)Medcom GmbH2014-04-03
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD (K140043)Microport Orthopedics, Inc.2014-04-03
ZOLL CODE WRITER (K132488)ZOLL Medical Corporation2014-04-03
DEPUY GLOBAL UNITE SHOULDER SYSTEM (K133834)Depuy(Ireland)2014-04-03
ALEUTIAN IBF SYSTEM (K133614)K2m, Inc.2014-04-03
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X (K131202)Dialysis Medical Solutions, LLC2014-04-03
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET (K140131)Emed Technologies Corporation2014-04-03
PERCLOT TOPICAL (K132105)Cryolife, Inc.2014-04-03
VIZION ULTRA (K133139)Viztek, LLC2014-04-03
VITALCONNECT PLATFORM BY VITAL CONNECT INC. (K132447)Vitalconnect, Inc.2014-04-03
MACH LED 2MC (K140461)Dr. Mach GmbH & Co. KG2014-04-03
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET (K140402)Medsource International, LLC2014-04-03
VARIAX 2 SYSTEM (K140376)Stryker Trauma AG2014-04-03
ACUITY PRO LEAD DELIVERY SYSTEM (K132914)Boston Scientific2014-04-03
XSTAT (DEN130016)Revmedx, Inc.2014-04-03
SIGNATURE PLANNER, SIGNATURE GUIDES (K140257)Materialise NV2014-04-02
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K133933)Boston Scientific Corporation2014-04-02
AHP 300, EMERGENCY PORTABLE VENTILATOR (K132021)Allied Healthcare Products, Inc.2014-04-02
INNESIS PEEK CERVICAL CAGE (K132483)Bk Meditech, Co., Ltd.2014-04-02
VARIAX CLAVICLE HOOK PLATE (K140259)Stryker Trauma AG2014-04-01
TABLET VIEWER SOFTWARE FOR IMAGE SUITE (K140271)Carestream Health, Inc.2014-04-01
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL (K133606)ArthroCare Corporation2014-04-01
OMNYX IDP FOR HER2 MANUAL APPLICATION (K131140)Omnyx, LLC2014-04-01
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C (K140541)Siemens Healthcare Diagnostics, Inc.2014-04-01
VADO STEERABLE SHEATH (K140420)Kalila Medical, Inc.2014-04-01
VUPAD (K140199)Sonomed, Inc.2014-04-01
MODIFIED DISTAL RADIUS PLATING SYSTEM (K133939)Biomet2014-04-01
IMBIBE NEEDLE (K140414)Orthovita, Inc.2014-04-01
SYNTHES SYNSONIC ULNA NAIL (K131984)Synthes (Usa)2014-03-31
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM (K134044)Cardio Tek, BV2014-03-31
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) (K131848)Puricore, Inc.2014-03-31
ICEROD CX CRYOABLATION NEEDLE (K140584)Galil Medical , Ltd.2014-03-31
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL (K140505)Siemens Healthcare Diagnostics, Inc.2014-03-31
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM (K132850)Rti Surgical, Inc.2014-03-31
MIROMATRIX BIOLOGICAL MESH (K134033)Miromatrix Medical, Inc.2014-03-31
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 (K133721)Pinnacle Spine Group, LLC2014-03-31
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (K133940)Biomet UK, Ltd.2014-03-28
I-HIP TOTAL HIP SYSTEM (K132572)Iconacy Orthopedic Implants, LLC2014-03-28
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS (K133344)Sebia2014-03-28
QUICK JET M (K133170)Micron Corp.2014-03-28
IOGYN SYSTEM (DEN130040)Iogyn, Inc.2014-03-28
B&B BUBBLER (K133210)S & T Medical Technologies, Inc.2014-03-28
EXTREMITY MEDICAL HAMMERTOE DEVICE (K133636)Extremity Medical, LLC2014-03-28
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR (K122298)Ajex Meditech., Ltd.2014-03-28
CORONIS 5MP (K133984)Barco N.V.2014-03-28
STERRAD 50/100S/200 TEST PACK (K130263)Advanced Sterilization Products2014-03-28
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861)Intuitive Surgical, Inc.2014-03-28
FLOCAP (K133540)Maxtec, Inc.2014-03-28
X-RAY TV SYSTEM SONIAL VISION G4 (K131075)Shimadzu Corp.2014-03-28
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER (K134016)Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014-03-28
NEUROSTAR TMS THERAPY SYSTEM (K133408)Neuronetics2014-03-28
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC (K133116)Conmed Corporation2014-03-28
PEEK FUSION IMPLANT (K133515)Mtp Solutions, LLC2014-03-28
ORTHOSCAN FD MINI C-ARM (K133174)Orthoscan, Inc.2014-03-28
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM (K133560)Conformis, Inc.2014-03-28
VITAL COUGH (K132988)Lung Assist, Inc.2014-03-28
AXERA 2 ACCESS SYSTEM (K140201)Arstasis, Inc.2014-03-28
PATHFAST CTNL CALIBRATORS (K130603)Mitsubishi Chemical Medience Corporation2014-03-27
PDE-NEO (K133719)Hamamatsu Photonics K.K.2014-03-27
ELECSYS PRECICONTROL TS (K140534)Roche Diagnostics2014-03-27
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET (K133930)Flower Orthopedics Corporation2014-03-27
LEXIPLIANT DILATOR SHEATH SET (K133631)Spectranetics Corporation2014-03-27
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K140106)Renovis Surgical Technologies, Inc.2014-03-27
SINGLE USE STERILE SYRINGE WITH NEEDLE (K133493)Jiangxi Kelun Medical Devices Manufacturing Co.,Lt2014-03-27
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR (K132002)Rayner Intraocular Lenses , Ltd.2014-03-27
BIOMET ACCESS SYSTEM (K132373)Biomet Spine (Aka Ebi, LLC)2014-03-27
VENTED MILLEX -GV, CATHIVEX -GV (K133004)Merck Millipore , Ltd.2014-03-27
MANDREL GUIDEWIRE (K140485)Lake Region Medical2014-03-27
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC (K133455)Pioneer Surgical Technology, Inc.2014-03-27
INTELLIVUE CL RESPIRATION POD (K132320)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014-03-26
OP300 (K133544)Palodex Group OY2014-03-26
RESOLUTIONMD MOBILE (K133508)Calgary Scientific, Inc.2014-03-26
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING (K133775)Exciton Technologies, Inc.2014-03-26
TOTAL ACROSS (K133539)Medtronic Vascular2014-03-26
MONOTEX (K140415)Riverpoint Medical2014-03-26
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT (K133807)Gambro Renal Products, Inc.2014-03-26
AMICO DH-W35 OPHTHALMOSCOPE SERIES (K131939)Amico Diagnostic Incorporated2014-03-26
WHIP MIX PREPPIES PLUS (K131760)Whip-Mix Corp.2014-03-26
AMIPLIVUE HSV 1&2 ASSAY (K140029)Quidel Corporation2014-03-26
VENTRAIN (K132759)Dolphys Medical B.V.2014-03-26
CORGRIP (K133599)Corpak Medsystems2014-03-26
COLLAGEN TENDON SHEET-DDI (CTS-DDI) (K140300)Rotation Medical, Inc.2014-03-26
ENCORE SYSTEM (K133680)Siesta Medical, Inc.2014-03-26
PEREGRINE SYSTEM INFUSION CATHETER (K140637)Ablative Solutions, Inc.2014-03-26
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673)Meridian Bioscience, Inc.2014-03-25
SILEX SACROILIAC JOINT FUSION SYSTEM (K140079)X-Spine Systems, Inc.2014-03-25
VEGA KNEE SYSTEM (K140452)Aesculap Implant Systems2014-03-25
CAAS WORKSTATION (K133993)Pie Medical Imaging2014-03-25
ASIR-V (K133640)Ge Medical Systems, LLC2014-03-25
SOLACE SOUND GENERATORS (K132965)Amplisound Hearing Products & Services2014-03-25
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 (K140393)Randox Laboratories Limited2014-03-25
CD HORIZON SPINAL SYSTEM (K140449)Medtronic Sofamor Danek, Inc.2014-03-25
NAUTILUS SPINAL SYSTEM (K140457)Life Spine, Inc.2014-03-25
SAFETY BIOPSY NEEDLE SYSTEM (K140137)Pfm Medical, Inc.2014-03-25
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT (K132017)Fisher & Paykel Healthcare, Ltd.2014-03-25
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM (K131703)Nova Biomedical Corporation2014-03-25
ASPIRE CRISTALLE (K133972)Fujifilm Medical Systems U.S.A, Inc.2014-03-25
NIO COLOR 2MP (K133663)Barco N.V.2014-03-25
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (K132250)Integra LifeSciences Corporation2014-03-24
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Every clearance here is in the API, with alerts when new ones post.