Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LIFESTENT TURBO BILIARY STENT SYSTEM (K061235)Edwards Lifesciences, LLC2006-06-05
B&L L-BETA, MODEL WL-B1 (K060347)B&L Biotech Co., Ltd.2006-06-05
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47 (K061426)Porous Media Corp.2006-06-05
IKOENGELO (K061006)Ikoetech, LLC2006-06-05
BRILLIANCE VOLUME (K060937)Philips Medical Systems (Cleveland), Inc.2006-06-05
ORAL-B SONIC COMPLETE (K061351)Braun GmbH2006-06-05
GLUCOPACK (K052469)Healthpia America Corp.2006-06-05
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N (K061308)Cardinal Health 200, Inc.2006-06-05
R&D LH-NRBC HEMATOLOGY CONTROL (K061320)R&D Systems, Inc.2006-06-02
MEDICAL INTERPOROUS (K051342)Bonyf AG2006-06-02
AXSYM DIGOXIN III (K061249)Abbott Laboratories2006-06-02
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE (K053305)Pt Mahakarya Inti Buana2006-06-02
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 (K061282)Beckman Coulter, Inc.2006-06-02
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM (K060536)Osteomed LP2006-06-02
CLEVER CHECK TD-3250 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEM, MODEL TD-3250 (K061073)Taidoc Technology Corporation2006-06-02
PORCELAIN PRIMER (K061322)J. Morita USA, Inc.2006-06-02
PLATELIA ASPERGILLUS EIA, MODEL 62793 (K060641)Bio-Rad2006-06-02
LARIAT LOOP APPLICATOR (K060721)Sentreheart2006-06-02
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX (K061171)Biosphere Medical, Inc.2006-06-02
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (K061314)Davol Inc., Sub. C. R. Bard, Inc.2006-06-02
ACCIN UNI-KNEE SYSTEM (K060670)Accin Corporation2006-06-02
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV (K060563)Pajunk GmbH2006-06-02
RITRACT SAFETY SYRINGE (K060002)Ritract , Ltd.2006-06-02
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM (K060138)Synthes (Usa)2006-06-02
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) (K060744)O'Brien Dental Lab, Inc.2006-06-02
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES (K061079)Medtrade Products , Ltd.2006-06-02
MBCP GEL (K060732)Biomatlante2006-06-02
STOCKERT S5 SYSTEM (K060053)Sorin Group Deutschland GmbH2006-06-02
LC STAR WITH NASAL ADAPTER (K061381)Pari Innovative Manufacturers, Inc.2006-06-02
SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES (K061240)Lucent Medical Systems2006-06-02
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W (K061031)Sorin Group Italia S.R.L.2006-06-02
MYTIS ARROW XXXX (K052254)Brainbase Corporation2006-06-01
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 (K061183)Confluent Surgical,Inc2006-06-01
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 (K061129)General Electric Co.2006-06-01
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K061189)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-06-01
AUTO SUTUR ENDO GIA STAPLERS (K061095)United States Surgical, A Division of Tyco Healthc2006-05-31
IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 (K060905)Iridex Corp2006-05-31
ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES (K061199)Braun GmbH2006-05-31
INSPIRSTAR GLOVE ELECTRODE (K061343)Inspirstar, Inc.2006-05-31
MICROTEK MEDICAL WARMING DRAPE (K060200)Microtek Medical, Inc.2006-05-31
ANCHOR PLUS/NEO ANCHOR PLUS (K053629)Kj Meditech2006-05-31
JUNIPER COOLING DEVICE (K060407)Juniper Medical Technology, Inc.2006-05-31
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (K061251)Dade Behring, Inc.2006-05-31
REFLECTION 3 ACETABULAR SYSTEM (K061253)Smith & Nephew, Inc.2006-05-31
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS (K060352)Health Line International Corporation2006-05-31
REMA SHAVER BLADES (K060172)Rema Medizintechnik GmbH.2006-05-31
AESCULAP BIPOLAR ACETABULAR CUP (K060707)Aesculap, Inc.2006-05-31
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION (K051104)Lapis Lazuli, NV2006-05-31
ACCUTECH ENDOLITE PROBE (K061025)Accutech Medical Technologies, Inc.2006-05-31
AUTOFUSER (K060258)Ace Medical Us, LLC2006-05-30
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (K061201)United States Endoscopy Group, Inc.2006-05-30
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (K060449)Guidant Corporation2006-05-30
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K060645)Roche Diagnostics Corp.2006-05-30
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) (K060189)Ives Eeg Solutions, Inc.2006-05-30
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES (K053363)Ad-Tech Medical Instrument Corp2006-05-30
DPOAE20 , ECLIPSE (K060539)Interacoustics A/S, Assens2006-05-30
NOD CHEMISTRY CONTROL (K060850)Bioresource Technology, Inc.2006-05-30
COMPREHENSIVE PRIMARY SHOULDER STEMS (K060692)Biomet Manufacturing Corp2006-05-30
CENTRICITY AW SUITE OPTION (K061372)Ge Healthcare Information Technologies2006-05-30
OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 (K060922)Oxlife, LLC2006-05-30
CARDIOIMMUNE XL CARDIAC MARKER CONTROL (K061196)Microgenics Corp.2006-05-30
CLEARADEX GEL (K060561)Cambridgemed2006-05-30
CARDIQ FUSION (K061370)GE Healthcare2006-05-30
REFA, PHYSIOLOGICAL AMPLIFIER (K060374)Tms International BV2006-05-30
QLAB QUANTIFICATION SOFTWARE (K061396)Philips Ultrasound, Inc.2006-05-30
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD (K060918)Aesculap, Inc.2006-05-26
RINSENDO (K052271)Air Techniques, Inc.2006-05-26
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT (K060722)Zimmer, Inc.2006-05-26
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (K061052)Philips Medical Systems North America, Inc.2006-05-26
LAPARO-THORACO VIDEOSCOPE XLTF-VAW (K053382)Olympus Medical Systems Corporation2006-05-26
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM (K060735)Axiom Worldwide, Inc.2006-05-26
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 (K060546)Breas Medical AB2006-05-26
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR (K061228)Bryan Keropian Dds2006-05-26
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 (K060811)Omron Healthcare, Inc.2006-05-25
MODIFICATION TO REBILDA DC (K060893)Voco GmbH2006-05-25
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 (K061295)Theralight, Inc.2006-05-25
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 (K061170)Resonance Innovations, LLC2006-05-25
CLEARBLUE EASY DIGITAL PREGNANCY TEST (K060128)Unipath , Ltd.2006-05-25
VANGUARD REMOVABLE MOLDED POLY TIBIA (K060525)Biomet Manufacturing Corp2006-05-25
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB (K061182)Cliniqa Corporation2006-05-25
BREAS, MODEL HA01 (K060790)Breas Medical AB2006-05-25
ACMI DUR-HL LASER SYSTEMS (K060752)Acmi Corporation2006-05-25
VENTURE ANTERIOR CERVICAL PLATE SYSTEM (K061274)Medtronic Sofamor Danek2006-05-25
PSL PORTABLE SLIT LAMP (K061330)Reichert, Inc.2006-05-25
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) (K060726)Smart Glove Corp. Sdn Bhd2006-05-25
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA (K060157)Immco Diagnostics, Inc.2006-05-25
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES (K053358)Ad-Tech Medical Instrument Corp2006-05-25
PURE-AID PREGNANCY TEST (K053452)Bio Focus Co., Lt.2006-05-25
MEMORY STAPLE (K060746)DePuy Orthopaedics, Inc.2006-05-25
RAPIDTOX (K053359)American Bio Medica Corp.2006-05-25
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM (K060506)Stryker Spine2006-05-25
PROCEED SURGICAL MESH (K060713)ETHICON, Inc.2006-05-25
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE (K061238)Dade Behring, Inc.2006-05-25
TRABECULAR METAL ACETABULAR AUGMENTS (K061067)Zimmer Trabecular2006-05-25
LTV 1200 VENTILATOR (K060647)Pulmonetic Systems, Inc.2006-05-25
MEDICAL DISPLAY, MDC1900-1LG (1LR) (K061305)Chi Lin Technology Co., Ltd.2006-05-25
MODIFIED MERCI RETRIEVER, MODEL 90092 (K061059)Concentric Medical, Inc.2006-05-25
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX (K061326)Barcoview Mis Edinburgh2006-05-25
ARCHITECT BNP ASSAY, MODEL 8K28 (K060964)Fujirebio Diagnostics,Inc.2006-05-25
SURGICAL FACE MASK (K060776)Hong YA Non-Woven Products Co., Ltd.2006-05-25
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Every clearance here is in the API, with alerts when new ones post.