Atlas FDA

2013

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

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RecordFirmDate
AEI DR. TERAUCHI ULTRASONIC TIPS (K122501)American Eagle Instruments, Inc.2013-03-29
SWIFT FX NANO (K123789)Resmed, Ltd.2013-03-29
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER (K130537)Biopsy Sciences, LLC2013-03-29
MUSCLE STIMULATION SYSTEM (K123642)Niveus Medical, Inc.2013-03-29
FLOWER SMALL AND MEDIUM BONE IMPLANTS (K123562)Flower Orthopedics Corporation2013-03-29
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS (K123484)St. shine Optical Co., Ltd.2013-03-29
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU (K130653)Ethicon Endo-Surgery, LLC2013-03-29
RMGI FILL (K130223)Pulpdent Corporation2013-03-29
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER (K122221)Taidoc Technology Corporation2013-03-29
CELLULAZE LASER (K123407)Cynosure, Inc.2013-03-29
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (K123509)Hitachi Medical Systems America, Inc.2013-03-29
LITECURE THERAPY SYSTEM MODEL LTS-1500 (K123014)Litecure, LLC2013-03-29
IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE (K124008)Ivoclar Vivadent, Agin2013-03-29
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (K121743)Sunmed, LLC2013-03-28
STRYKER VENOM ELECTRODES AND CANNULAE (K123178)Stryker Instruments, Instruments Div.2013-03-28
FIREBIRD SPINAL FIXATION SYSTEM (K130176)Orthofix2013-03-28
INTESS LUMBAR CAGE (K123100)Kalitec Direct, LLC2013-03-28
12MM AND 13MM TIBIAL NAILS (K130625)Advanced Orthopaedic Solutions, Inc.2013-03-28
MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (K122175)Tecres S.P.A.2013-03-28
BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 (K122770)Biomet Manufacturing Corp2013-03-28
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM (K123512)Biodenta Swiss AG2013-03-28
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES (K123139)Asi Medical, Inc.2013-03-28
BARRICADE EMBOLIZATION COIL SYSTEM (K123338)Blockade Medical2013-03-28
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 (K130336)Eizo Nanao Corporation2013-03-28
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES (K122850)Meditech Advisors, LLC2013-03-28
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER (K122744)Prospera Corporation2013-03-28
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM (K123272)Neocoil, LLC2013-03-28
BOEHRINGER GASTRIC SIZING TUBE (K130483)Boehringer Laboratories, LLC2013-03-28
CARDIOMEM (K122272)Getemed Medizin- Und Informationstechnik AG2013-03-28
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM (K123624)Mimosa Acoustics, Inc.2013-03-28
AXSOS 3 TI LOCKING PLATE SYSTEM (K123964)Stryker Trauma AG2013-03-28
QUANTIEN MEASUREMENT SYSTEM (K123984)Radi Medical Systems AB2013-03-28
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (K122494)Hemostasis, LLC2013-03-27
MICROLINE FLEXIBLE LIGATING SHEARS (K124029)Microline Surgical, Inc.2013-03-27
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF (K123762)Medtronic, Inc.2013-03-27
TBD (K123859)Lensar, Inc.2013-03-27
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT (K113823)The Binding Site Group , Ltd.2013-03-27
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM (K123870)Megagen Implant Co., Ltd.2013-03-27
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC (K121823)Wescor, Inc.2013-03-27
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST (K122480)International Biophysics Corporation2013-03-27
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 (K122560)Pan-America Hyperbarics, Inc.2013-03-26
INSIGNIA DIGICAST (K123118)Ormco Corp.2013-03-26
ULTRASAFE PLUS PASSIVE NEEDLE GUARD (K123743)Safety Syringes, Inc.2013-03-26
VENACURE EVLT NEVERTOUCH PROCEDURE KIT (K130671)AngioDynamics, Inc.2013-03-26
NOBELCLINICIAN (K123976)Nobel Biocare AB2013-03-26
HIGH METABOLITE QUALICHECK (K130415)Radiometer Medical Aps2013-03-26
SMART-WELL INCUBATOR (K122362)Mesa Laboratories, Inc.2013-03-26
LIFELINES IEEG (K123665)Kvikna Ehf2013-03-25
SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K130173)FUJIFILM Sonosite, Inc.2013-03-25
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K130754)Siemens Medi Cal Solutions, Inc.2013-03-25
RAMPART O AND RAMPART P (K130396)Spineology, Inc.2013-03-25
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL (K123745)Biomecanica Industria E Comerico DE Productos Orto2013-03-25
PRO-DENSE BONE GRAFT SUBSTITUTE (K113871)Wrightmedicaltechnologyinc2013-03-25
AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) (K124059)Lauer Membran Wassertechnik GmbH2013-03-25
HEMOSIL READIPLAS TIN (K122584)Instrumentation Laboratory CO2013-03-24
FIBERLASE ENDURE CO2 FIBER (K130164)Lumenis, Ltd.2013-03-24
AXERA 2 ACCESS SYSTEM (K123618)Arstasis, Inc.2013-03-24
BALANCED KNEE SYSTEM HIGH FLEX PS (K123457)Ortho Development Corp.2013-03-22
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771)Beckman Coulter, Inc.2013-03-22
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE (K123652)Spineology, Inc.2013-03-22
MRII CRAINIAL DRILL (K122456)Mri Interventions, Inc.2013-03-22
PROCARE MONITOR B20 (K122253)Ge Medical Systems China Co., Ltd.2013-03-22
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS (K124004)Medtronic Navigation, Inc.2013-03-22
AXIS-SHIELD ACVTIVE-B12 (K121946)Axis-Shield Diagnostics, Ltd.2013-03-22
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST (K122037)Medtronic Sofamor Danek, Inc.2013-03-22
DIMENSION EXL WITH LM SYSTEM (K130276)Siemens Healthcare Diagnostics, Inc.2013-03-22
ALCO-SCREEN (K121247)Chematics, Inc.2013-03-22
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) (K130141)Hitachi Chemical Diagnostics, Inc.2013-03-22
HEINE MINI 3000 LED OPHTHALMOSCOPE (K123587)Heine Optotechnik GmbH & Co. KG2013-03-22
MORTARA SURVEYOR PATIENT MONITOR (K123556)Mortara Instrument, Inc.2013-03-22
FEMORAL ACCESS VENOUS CANNULAE (K123303)Edwards Lifesciences, LLC2013-03-22
CAIMAN SEAL AND CUT TECHNOLOGY (K130596)Aesculap, Inc.2013-03-22
VARIAX 2 COMPRESSION PLATING SYSTEM (K130009)Stryker Trauma AG2013-03-22
ENDOSCOPIC INTRODUCER (K123013)Novadaq Technologies, Inc.2013-03-22
BP652N (HEM-6300-Z) (K123498)Omron Healthcare, Inc.2013-03-21
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981)Siemens Healthcare Diagnostics2013-03-21
CAPNO MODULE, 92517 (K130112)Spacelabs Healthcare2013-03-21
CLEVER TD-7001NEBULIZER (K122060)Taidoc Technology Corporation2013-03-21
PASS OCT SPINAL SYSTEM (K121979)Medicrea International2013-03-21
S9 VPAP TX (K123511)Resmed, Ltd.2013-03-21
VEEDA 100% COTTON MENSTRUAL TAMPON (K130609)Naturalena Brands, Inc.2013-03-21
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM (K130619)Siemens Medical Solutions USA, Inc.2013-03-21
GARAVENTA X3 INCLINED PLATFORM LIFT (K122206)Garaventa (Canada) Ltd [Dba Garaventa Lift]2013-03-21
BETA-TCP GRANULES (K120354)Skeletal Kinetics, LLC2013-03-21
APPS-HEALTH01 (K122098)Andon Health Co, Ltd.2013-03-21
SUNRAY FETAL MONITOR (K123335)Sunray Medical Apparatus Co., Ltd.2013-03-21
ADVANCE TOTAL KNEE SYSTEM-PATELLA (K122218)Wrightmedicaltechnologyinc2013-03-21
DORNIER MEDILAS UROPULSE (K130344)Dornier Medtech America, Inc.2013-03-21
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX (K121894)Luminex Molecular Diagnostics, Inc.2013-03-21
PINPOINTE FOOTLASER (K130413)Nuvolase, Inc.2013-03-21
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 (K121772)Philips Medical Systems Nederland B.V.2013-03-21
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM (K130221)Medimecca Co., Ltd.2013-03-21
SHENZHEN MED-LINK PULSE OXIMETER PROBE (K113727)Shenzhen Med-Link Electronics Tech Co., Ltd.2013-03-21
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130206)Pentax of America, Inc.2013-03-20
BD ALCOHOL SWAB (K121655)Becton, Dickinson & CO2013-03-20
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES (K123403)Stryker Trauma AG2013-03-20
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE (K130433)Sorin Group Italia S.R.L.2013-03-20
VANGUARD XP KNEE SYSTEM (K122160)Biomet Manufacturing Corp2013-03-20
MIRADA RTX (K130393)Mirada Medical, Ltd.2013-03-20
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER (K130257)St Jude Medical2013-03-20
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Every clearance here is in the API, with alerts when new ones post.