Atlas FDA

2013

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

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RecordFirmDate
REPROCESSED DILATING TIP TROCARS (K132629)Stryker Sustainability Solutions2013-12-31
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (K131053)The Anspach Effort, Inc.2013-12-31
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N (K133081)Advanced Orthopaedic Solutions, Inc.2013-12-31
NASAL EASE ALLERGY BLOCKER (K132520)Hi-Tech Pharmacal, Inc.2013-12-31
UNBALLOON NON-OCCLUSION MODELING CATHETER (K133026)LeMaitre Vascular, Inc.2013-12-31
M1 CAPNOGRAPHY MASK (K133806)Monitor Mask, Inc.2013-12-31
MONUMENT SPACERS (K132559)Globus Medical, Inc.2013-12-30
G-SCAN BRIO (K133490)Esaote, S.p.A.2013-12-30
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM (K132867)Cayenne Medical, Inc.2013-12-30
VISUM BLADE LED SURGICAL LIGHTING SYSTEM (K132747)Stryker Communications2013-12-30
CLIQ DV-300 ASPIRATOR (K132308)Ding Hwa Co., Ltd.2013-12-30
COMPRESSYN STAPLE (K132875)Dallen Medical, Inc.2013-12-30
REUNION RSA SHOULDER SYSTEM (K130895)Howmedica Osteonics Corp.2013-12-27
LASER-STIM (K131259)Shenzhen Dongdixin Technology Co., Ltd.2013-12-27
NXSTAGE 1.6M2 DIALYZER (K131050)Nxstage Medical, Inc.2013-12-27
EASY-LOAD LENS DELIVERY SYSTEM (K132481)Bausch & Lomb2013-12-27
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (K133505)Samsung Medison Co., Ltd.2013-12-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) (K132674)Becton, Dickinson and Company2013-12-27
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU (K132007)Stericycle, Inc.2013-12-27
CEREBRALOGIK- AEEG (K131789)Mennen Medical , Ltd.2013-12-27
KINGTECH FOREHEAD THERMOMETER (K133113)Kingtech Enterprise, Ltd.2013-12-26
NEUROVISION MEDICAL MOTION SENSOR (K130570)Neurovision Medical Products, Inc.2013-12-26
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283)Candela Corp.2013-12-26
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE (K133422)Neocoil, LLC2013-12-26
OLEA SPHERE (K132095)Olea Medical2013-12-26
KINGTECH DIGITAL THERMOMETER (K133111)Kingtech Enterprise, Ltd.2013-12-26
SWABCAP AND SWABFLUSH (K130975)Excelsior Medical Corp.2013-12-24
COROENT STERILE IMPLANTS SYSTEM (K132601)Nu Vasive, Incorporated2013-12-24
ARM AUTOMATIC BLOOD PRESSURE MONITOR (K130325)Shenzhen Pump Medical System Co., Ltd.2013-12-24
SIGNIFY BIOACTIVE (K130977)Globus Medical, Inc.2013-12-24
VELOX ANTERIOR CERVICAL PLATE SYSTEM (K131521)Spinecraft, LLC2013-12-24
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM (K132511)Abbott Diabetes Care, Inc.2013-12-24
MOZEC - RX PTCA BALLOON DILATATION CATHETER (K131169)Meril Life Sciences Private Limited2013-12-24
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE (K131724)Pioneer Surgical Technology, Inc.2013-12-24
VENUE 50 (K133431)GE Healthcare2013-12-24
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE (K132787)Aap Implantate AG2013-12-24
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM (K130572)Implant Direct Sybron Manufacturing, LLC2013-12-24
INTUITION - TDA, TVA, PARAMETRIC MAPPING (K131447)Terarecon,Inc.2013-12-24
ACUSON (K131164)Siemens Medical Solutions USA, Inc.2013-12-24
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS (K123763)Immunodiagnostic Systems , Ltd.2013-12-24
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS (K130519)Philips Lighting Company2013-12-24
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K132854)Yung Sheng Optical Co., Ltd.2013-12-23
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634)Cook, Inc.2013-12-23
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (K131821)Phadia US, Inc.2013-12-23
LAURIMED POLYPVAC MICRODEBRIDER (K133133)Laurimed, LLC2013-12-23
IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 (K131901)3B Medical, Inc.2013-12-23
TOTALSHIELD SURGICAL HELMET SYSTEM (K132386)Zimmer, Inc.2013-12-23
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS (K133627)CooperVision, Inc.2013-12-23
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED (K132500)Cure Medical, LLC2013-12-23
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT (K122932)Fogless International AB2013-12-23
LIPIFLOW THERMAL PULSATION SYSTEM (K133127)Tearscience, Inc.2013-12-23
ASCOT (K132310)Backroads Consulting, Inc.2013-12-23
CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (K131787)Keeler, Ltd.2013-12-23
TONE-A-MATIC (K130052)Tone-A-Matic International, Inc.2013-12-20
ELECTRONIC PULSE MASSAGER (K131933)Gurin Products, LLC2013-12-20
MESO TENDON MATRIX (K133169)Kensey Nash Corporation Dba Dsm Biomedical2013-12-20
AGGREGUIDE (K122162)Aggredyne, Inc.2013-12-20
OCULAR FORCE GAUGE (K132917)Ocular Therapeutix, Inc.2013-12-20
AMPLIVUE GBS ASSAY (K133503)Quidel Corporation2013-12-20
BIOMARC FIDUCIAL MARKER (K132708)Carbon Medical Technologies, Inc.2013-12-20
SEAL BIOPSY VALVE - REUSABLE (K132776)Endochoice, Inc.2013-12-20
LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) (K133338)Covidien, Formerly Valleylab, A Division of Tyco H2013-12-20
AIRFIT N10 (K132887)Resmed, Ltd.2013-12-20
BERNOULLI ENTERPRISE SOFTWARE (K130208)Cardiopulmonary Corp.2013-12-20
AIR BARRIER SYSTEM (ABS) (K123006)Nimbic Systems, Inc.2013-12-20
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM (K130284)ACON Laboratories, Inc.2013-12-20
NEOTRACT UROLIFT SYSTEM (K133281)Neotract, Inc.2013-12-20
K-ETCHANT SYRINGE; NEEDLE TIP (E) (K133078)Kuraray Noritake Dental, Inc.2013-12-20
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 (K132026)Mindray DS USA, Inc.2013-12-20
GENPRIME DRUGS OF ABUSE READER SYSTEM (K130082)Genprime, Inc.2013-12-20
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (K132530)Datex-Ohmeda, Inc.2013-12-20
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM (K131765)Conmed Corporation2013-12-20
IMAGE1 SPIES (K131953)KARL STORZ Endoscopy-America, Inc.2013-12-20
XVWEB (K132342)Apteryx, Inc.2013-12-20
IDEAL (K132428)Jiangsu Ideal Medical Science & Technology Co., LT2013-12-20
CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE (K133641)Volcano Corporation2013-12-20
PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 (K133587)St. Jude Medical Systems AB2013-12-20
ORTHOVIS PREOPERATIVE PLAN (K133367)Custom Orthopaedic Solutions2013-12-20
ELECTROTHERAPY DEVICE (COMBO UNIT) (K130691)Guangzhou Finecure Medical Equipment Co.,Ltd2013-12-20
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (K132555)The Binding Site2013-12-20
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS (K133566)Boston Scientific Corp2013-12-20
BD MAX MRSA XT, BD MAX INSTRUMENT (K133605)Geneohm Sciences Canada, Inc.2013-12-20
SUNETICS CLINICAL BIO-STIMULATION LASER (K132646)Sunetics International Marketing Group, LLC2013-12-20
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL (K131510)Blackwell Device Consulting2013-12-20
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS (K132715)Bausch & Lomb, Incorporated2013-12-20
CAPSTONE SPINAL SYSTEM (K133650)Medtronic Sofamor Danek USA, Inc.2013-12-20
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM (K132671)Stryker Corporation2013-12-20
GMK SHORT STEM (K133630)Medacta International2013-12-20
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K133626)MicroVention, Inc.2013-12-20
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM (K133052)Nuvasive, Inc.2013-12-20
BARLE TISSUE ADHESIVE 2 (K132243)Advanced Medical Solutions (Plymouth), Ltd.2013-12-20
KC 300 SURGICAL MASK (K131879)Kimberly-Clark Corp.2013-12-20
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER (K131935)Nipro Medical Corporation2013-12-20
NIVATOPIC PLUS (K132329)Nivagen Pharmaceuticals, Inc.2013-12-20
REST ASSURED EXTRA COMFORT NITE PROTECTOR (K133423)Ranir, LLC2013-12-20
INFIX ANTERIOR LUMBAR SYSTEM (K132790)Zimmer Spine, Inc.2013-12-20
VIA MICROCATHETER, VIA PLUS MICROCATHETER (K132652)Sequent Medical, Inc.2013-12-20
WANDY SELF-ADHESIVE ELECTRODES (K132998)Wandy Rubber Industrial Co., Ltd.2013-12-20
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM (K133569)Bard Peripheral Vascular, Inc.2013-12-20
MULTI-STAGE SNARE (K133513)United States Endoscopy Group, Inc.2013-12-20
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Every clearance here is in the API, with alerts when new ones post.