Atlas FDA

2014

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

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RecordFirmDate
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) (K140890)Hartalega NGC Sdn. Bhd.2014-07-24
NOVAPROBE LED LIGHT SOURCE (K131226)Novaprobe Incorporated2014-07-24
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA (K133156)Siemens Healthcare Diagnostics, Inc.2014-07-24
PLIF LITE AND TLIF LITE (K132907)Sintea Plustek2014-07-24
THERMOPULSE (K131926)Ibramed Equipamentos Medicos2014-07-24
AMPLIVUE GAS ASSAY (K141173)Quidel Corporation2014-07-24
MICR02 OSA DEVICE (K133683)Microdental, Inc.2014-07-24
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM (K140498)STERIS Corporation2014-07-24
COLONGLIDE LUBRICANT (K141028)Pediatric Pharmaceuticals, Inc.2014-07-24
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM (K140523)Coloplast A/S2014-07-24
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE (K141711)Pontis Orthopaeeics, LLC2014-07-24
GIS ENDOSCOPIC OPTICAL LENS (K140295)Gi Scientific, LLC2014-07-24
C-JAWS CERVICAL COMPRESSIVE STAPLE (K133906)Medicrea International2014-07-24
PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE (K133336)Pjur Group Luxembourg S.A.2014-07-24
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE (K133670)Neocoil, LLC2014-07-24
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM (K141750)Infopia Co, Ltd.2014-07-24
NOBELPROCERA OVERDENTURE BAR (K132749)Nobel Biocare USA, LLC2014-07-24
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (K140096)Hmicro, Inc.2014-07-24
FLEXI-LUME LED SYSTEM (K140281)Epic Medical Concepts & Innovations2014-07-24
ORTHO SOLUTIONS ULTOS PLATING SYSTEM (K141784)Ortho Solutions Limited2014-07-23
ARTHROSCOPIC ENERGY SYSTEM (K140578)Conmed Corporation2014-07-23
INFX-8000V, V5.30 (K133535)Toshibamedical Systems Corporation2014-07-23
OKAMOTO STUDDED CONDOM (K141256)Okamoto USA, Inc.2014-07-23
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM (K140775)Spectranetics Corporation2014-07-23
IFUSE IMPLANT SYSTEM (K141049)SI-BONE, Inc.2014-07-23
DYNAMIC NEUROSCREENING DEVICE (K141208)Prosenex2014-07-23
CADWELL SPIKE AND SEIZURE DETECTOR (K140552)Cadwell2014-07-23
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES (K132820)Vilex, Inc.2014-07-23
SIS HERNIA GRAFT (K133306)Cook Biotech, Inc.2014-07-23
CASPIAN SPINAL SYSTEM (K141284)K2m, Inc.2014-07-23
INTELLIJOINT HIP (K133759)Intellijoint Surgical, Inc.2014-07-23
EEVA DISH (WITH 12 MICROWELLS) (K141663)Auxogyn, Inc.2014-07-22
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 (K131721)Comed Medical Systems Co., Ltd.2014-07-22
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE (K141652)Cedars-Sinai Medical Center2014-07-22
VELOXTM INTERBODY FUSION SYSTEM (K140864)U&I Corp.2014-07-22
EQUALIZER OCCLUSION BALLOON CATHETER (K140273)Boston Scientific Corp2014-07-22
VARIAX ELBOW PLATING SYSTEM (K141677)Stryker Trauma AG2014-07-22
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K141678)Abbott Vascular2014-07-22
OARTRAC SYSTEM (K141154)Radiadyne2014-07-22
BIO-CONNEKT WOUND MATRIX (K140456)MLM Biologics, Inc.2014-07-22
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW (K140876)Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic2014-07-22
PICOSURE WORKSTATION (K133364)Cynosure, Inc.2014-07-22
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS (K130097)American Medical Manufacturing, Inc./ Advanced Med2014-07-22
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING (K140487)STERIS Corporation2014-07-22
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY (K141583)Shaser, Inc.2014-07-22
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE (K133370)Signature Orthopaedics Pty Limited2014-07-22
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV (K140726)Boston Scientific Corp2014-07-21
BIOSURE HEALICOIL PK INTERFERENCE SCREW (K140879)Smith & Nephew, Inc.2014-07-21
THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER (K134031)Boston Scientific Corporation2014-07-21
AZUL PERSONAL LUBRICANT (K141034)Church & Dwight Co., Inc.2014-07-21
EXCIA TOTAL HIP SYSTEM (K140915)Aesculap Implant Systems, LLC2014-07-21
BABYMEG BIOMAGNETOMETER SYSTEM (K133419)Tristan Technologies, Inc.2014-07-21
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER (K141118)Ev3, Inc.2014-07-18
POLYSYN SURGICAL SUTURE (K141625)Surgical Specialties Corp2014-07-18
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS (K141219)Biomet Manufacturing Corp2014-07-18
LEVO TINNITUS MASKING SOFTWARE DEVICE (K140845)Otoharmonics Corp2014-07-18
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER (K140518)Geistlich Pharma AG2014-07-18
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE (K132732)Medyssey USA, Inc.2014-07-18
ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM (K141641)Zonare Medical Systems, Inc.2014-07-18
VOLUSON S6, VOLUSON S8 (K141639)GE Healthcare2014-07-18
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS (K141280)Seinoh Optical Co. , Ltd.2014-07-18
THE BELMONT RAPID INFUSER (K141654)Belmont Instrument Corporation2014-07-18
POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES (K133699)Pt. Smartglove Indonesia2014-07-18
ARTHREX PIP DART (K141577)Arthrex, Inc.2014-07-18
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (K140200)Neuroinvent, Inc.2014-07-18
ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM (K133551)Zimmer Dental, Inc.2014-07-18
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT (K141265)Elitechgroup2014-07-18
ALMA DIODE TABLETOP LASER (K140005)Alma Lasers , Ltd.2014-07-18
VARIAX DISTAL RADIUS PLATING SYSTEM (K141430)Stryker Leibinger GmbH & Co KG2014-07-18
PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE (K133233)Pjur Group Luxembourg S.A.2014-07-18
AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM (K140082)Tornier S.A.S.2014-07-18
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL (K140897)Siemens Medical Solutions USA, Inc.2014-07-18
OPTILITE C1 INACTIVATOR KIT (K141100)The Binding Site Group , Ltd.2014-07-18
TATTOOSTAR EFFECT COMBO (K131757)Asclepion Laser Technologies GmbH2014-07-17
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM (K140504)Vascular Pathways, Inc.2014-07-17
D2 HEMOSTANTIC DRESSING (K140757)Z-Medica, LLC2014-07-17
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES (K140499)STERIS Corporation2014-07-17
NUVIS ARTHROSCOPE (K140903)Integrated Endoscopy, Inc.2014-07-17
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET (K141143)Roche Diagnostics2014-07-17
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) (K141647)Healgen Scientific,, LLC2014-07-17
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL (K140515)STERIS Corporation2014-07-17
FINGERTIP PULSE OXIMETER (K140682)Beijing Choice Electronic Technololgy Co., Ltd.2014-07-17
SHILLA GROWTH GUIDANCE SYSTEM (K140750)Medtronic Sofamor Danek USA, Inc.2014-07-17
DELWORKS DR SYSTEM (K140825)Del Medical, Inc.2014-07-17
SENSITITRE SUSCEPTIBILITY PLATES (K141000)Thermo Fisher Scientific2014-07-16
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC (K141563)Rayence Co., Ltd.2014-07-16
PROCTIGARD (K140558)Access Pharmaceuticals, Inc.2014-07-16
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC (K141566)Rayence Co., Ltd.2014-07-16
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC (K140844)Synergy Biomedical, Inc.2014-07-16
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) (K140142)Choicespine, LP2014-07-16
ACCULIF TL AND PL CAGE (K141217)Stryker Corporation2014-07-16
G-TL (K133568)Vitrolife, Inc.2014-07-16
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER (K141112)Boston Scientific2014-07-16
PORCINE ANORGANIC BONE MINERAL (K140714)Collagen Matrix, Inc.2014-07-16
MILESTONE SPINAL SYSTEM (K133053)Weigao Orthopaedic Device Co., Ltd.2014-07-15
GMK SPHERE EXTENSION (K140826)Medacta International2014-07-15
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES (K140813)Covidien2014-07-15
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE (K133813)Expanding Orthopedics, Inc.2014-07-15
VICTUS FEMTOSECOND LASER PLATFORM (K140615)Technolas Perfect Vision GmbH2014-07-15
CORMATRIX ECM FOR VASCULAR REPAIR (K140789)Cormatrix Cardiovascular, Inc.2014-07-15
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