Atlas FDA

2014

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

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RecordFirmDate
BPROSOFT CASP PC SOFTWARE (K131916)Healthstats International Pte. , Ltd.2014-03-11
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (K140248)Hitachi Chemical Diagnostics, Inc.2014-03-11
ACCURO 3000 ULTRASOUND SCANNER (K132736)Rivanna Medical, LLC2014-03-11
NOVEON (K122358)Hogan Lovells US LLP2014-03-11
REVERE STABILIZATION SYSTEM (K133350)Globus Medical, Inc.2014-03-11
CIOS ALPHA (K132094)Siemens Medi Cal Solutions, Inc.2014-03-11
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL (K133401)Siemens Medical Solutions USA, Inc.2014-03-11
ISYS 1 (U.S),ACCESSORY, NON-STERILE (K131433)Isys Medizintechnik GmbH2014-03-11
ULTIMUM EV HEMOSTASIS INTRODUCER (K140327)St Jude Medical2014-03-11
CEFALY (DEN120019)Stx-Med Sprl2014-03-11
NEWTRON P5 XS B.LED (K132322)Satelec - Acteon Group2014-03-11
OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM (K133386)Ortho Development Corp.2014-03-11
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE (K133483)Portable Therapeutix2014-03-11
KOWA SL-17 (K133755)Kowa Co. , Ltd.2014-03-11
BIOFUSIONARY BEBE (K121123)Rocky Mountain Biosystems, Inc.2014-03-10
IMPACT MODEL 323 ASPIRATOR (K133196)Impact Instrumentation, Inc.2014-03-10
CMC MINI TIGHTROPE (K140328)Arthrex, Inc.2014-03-10
DEPUY PINNACLE ALTRX ACETABULAR LINERS (K132959)DePuy Orthopaedics, Inc.2014-03-10
BWCSH-1 SHARPS CONTAINER (K131708)Bradford Wright Companies, Inc.2014-03-10
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) (K140267)Siemens Healthcare Diagnostics, Inc.2014-03-10
MM-SEAL (K123276)Micro-Mega Societe Anonyme2014-03-10
VAN HIP FRACTURE SYSTEM (K133104)Epix Orthopaedic, Corp.2014-03-10
T4/T5 HYTREL TOGAS (K121664)Stryker Corporation2014-03-10
NEWTRON P5, NEWTRON P5 B.LED (K132267)Satelec - Acteon Group2014-03-10
ACUMED SUTURE ANCHOR SYSTEM (K133469)Acumed, LLC2014-03-10
DERMABOND PRINEO SKIN CLOSURE SYSTEM (K133864)ETHICON, Inc.2014-03-10
HEINE MINI 3000(R) OPHTHALMOSCOPE (K131959)Heine Optotechnik GmbH & Co. KG2014-03-07
NAVIGATOR HD URETERAL ACCESS SHEATH SETS (K140323)Boston Scientific2014-03-07
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS (K140291)Volcano Corporation2014-03-07
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT (K134026)Olympus Medical Systems Corp.2014-03-07
PRO-TOE HAMMERTOE FIXATION SYSTEM (K140148)Wrightmedicaltechnologyinc2014-03-07
TABLE (K140093)Anatomage, Inc.2014-03-07
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT (K133527)Osstem Germany GmbH2014-03-07
FLASH AR; FLASH AR QUICK (K133436)3M Deutschland GmbH2014-03-07
IMPAX VOLUME VIEWING 3.0 (K133135)Agfa Healthcare N.V.2014-03-07
BLACKBIRD SPINAL SYSTEM (K133214)Choicespine, LP2014-03-07
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM (K133363)Ldr Spine USA, Inc.2014-03-07
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL (K132945)I.T.S. GmbH2014-03-07
MALE LATEX CONDOM (K132107)Nulatex Sdn. Bhd.2014-03-07
CHARLOTTE (TM) SNAP-OFF SCREW (K133713)Wrightmedicaltechnologyinc2014-03-07
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER (K140286)Cordis, A Johnson & Johnson Co.2014-03-07
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM (K131750)Apex BioTechnology Corp.2014-03-06
O2 NASAL CANNULA WITH CO2 MONITORING (K140113)Flexicare Medical, Ltd.2014-03-06
OPTIGLAZE COLOR (K133836)GC America, Inc.2014-03-06
ELITE IBF (K133459)Innova Spinal Technologies, LLC2014-03-06
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS (K133036)Amendia, Inc.2014-03-06
FLASH BITE (K133400)3M Espe AG2014-03-06
AIRWAY SUPPORT SYSTEM / AIRPORT (K131506)Abeon Medical Corporation2014-03-06
CATHETER INTRODUCER SHEATH (K131627)Edwards Lifesciences, LLC2014-03-06
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN (K131912)Teleflex, Inc.2014-03-06
VENTRIPOINT MEDICAL SYSTEM (K140153)Ventripoint, Inc.2014-03-06
UCP MULTI-DRUG TEST KEY CUPS (K132812)Ucp Biosciences, Inc.2014-03-06
MICROTABLE SYSTEM (K132611)Fred Haer Company, Inc.2014-03-06
N-FORCE FIXATION SYSTEM (K132244)Innovision, Inc.2014-03-06
BREATHE NIOV VENTILATION SYSTEM (K131562)Breathe Technologies2014-03-06
MODEL-BASED RSA SOFTWARE (K133966)Halifax Biomedical, Inc.2014-03-06
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER (K133754)Integra LifeSciences Corporation2014-03-06
ZEDVIEW (K133022)Lexi Co., Ltd.2014-03-06
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) (K132714)Vision Science Co., Ltd.2014-03-05
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT (K140263)Lexion Medical, LLC2014-03-05
ANGIOVAC CANNULA (K133445)Vortex Medical, Inc.2014-03-05
CONTEC ELECTROCARDIOGRAPH (K131900)Contec Medical System Co., Ltd.2014-03-05
NMI PICC IV (K140266)Navilyst Medical, Inc.2014-03-05
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII (K140208)Edwards Lifesciences, LLC2014-03-05
IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL (K140258)Siemens Healthcare Diagnostics, Inc.2014-03-05
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES (K133619)Grandway Technology (Shenzhen) Limited2014-03-05
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM (K133254)Cynosure, Inc.2014-03-05
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT (K133740)Sauflon Pharmaceuticals, Ltd.2014-03-05
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES (K133618)Grandway Technology (Shenzhen) Limited2014-03-05
ALLURA XPER FD; OR TABLE (K133292)Philips Medical Systems Nederland B.V.2014-03-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130751)Cabin Plastic Co., Ltd.2014-03-05
VELOFIXTM INTERBODY FUSION SYSTEM (K132926)U&I Corp.2014-03-05
ANDON BLOOD PRESSURE CUFF (K133117)Andon Health Co, Ltd.2014-03-04
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE (K131788)Healthstats International Pte. , Ltd.2014-03-04
RITHM ID ELECTROPHYSIOLOGY CATHETER (K133028)Synaptic Medical Limited2014-03-04
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) (K133472)Souflon Pharmaceuticals, Ltd.2014-03-04
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED (K133339)Zimmer Dental, Inc.2014-03-04
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT (K132908)Medtec, Inc.2014-03-04
NOVOPORE DRESSING (K132936)Polynovo Biomaterials Pty, Ltd.2014-03-04
HEM-7320 (K133383)Omron Healthcare, Inc.2014-03-04
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM (K133525)Changzhou Dean Medical Instrument Co, Ltd.2014-03-04
LIGHTHOUSE URINARY CATHETER (K140099)Seedings Life Science Ventures, LLC2014-03-04
AIRPURGE (DEN080009)Anesthesia Safety Products, LLC2014-03-04
SONIC WINDOW (K140126)Analogic Corporation2014-03-04
SFI-ANCHOR (K130618)Cendres & Metaux SA2014-03-03
MOERAE VEIN PREPARATION KIT (K131659)Moerae Matrix, Inc.2014-03-03
NXSTAGE SYSTEM ONE WITH NXVIEW (K133547)Nxstage Medical, Inc.2014-03-03
VISICLEAR SMOKE EVACUATION SYSTEM (K131402)Buffalo Filter Co., Inc.2014-03-03
HEARTSCAN SOFTWARE (K133937)Morpheus Imaging, Inc.2014-03-03
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL (K133668)Shoulder Options, Inc.2014-03-03
SKINTELL (K132800)Agfa Healthcare N.V.2014-03-03
IPM WOUND GEL BIO (K123193)Glycobiosciences, Inc.2014-03-03
ICONIX ALL SUTURE ANCHORS (K133671)Stryker Corp.2014-02-28
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548)Synthes (USA) Products, LLC2014-02-28
CHARLOTTE CLAW PLATE SYSTEM (K133715)Wrightmedicaltechnologyinc2014-02-28
JINTRONIX REHABILITATION SYSTEM (JRS) (K130847)Jintronix, Inc.2014-02-28
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS (K133119)Arjohuntleigh Polska SP Z.O.O.2014-02-28
ADVANCED VIEWER (K132763)Brainlab AG2014-02-28
MONODERM SURGICAL SUTURE (K140227)Surgical Specialties Corp2014-02-28
THE BITE GUARD (K132469)International Profit Builders, Inc.2014-02-28
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Every clearance here is in the API, with alerts when new ones post.