Atlas FDA

2006

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

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RecordFirmDate
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648)DePuy Orthopaedics, Inc.2006-09-11
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC (K061471)Microlife Intellectual Property GmbH2006-09-11
HOSPIRA ENTERAL FEEDING SET, MODEL 20640 (K061432)Hospira, Inc.2006-09-11
VOYAGER PACS SYSTEM (K062062)Voyager Imaging2006-09-11
RENALSOFT (K061515)Baxter Healthcare Corp2006-09-11
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 (K062058)Bayer Healthcare2006-09-11
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH (K061802)Dade Behring, Inc.2006-09-11
BOSWORTH DENTIN RESIN (K061611)Harry J. Bosworth Co.2006-09-11
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062022)Trek Diagnostic Systems, Inc.2006-09-11
SYNTHES 3.5MM SPRING PLATE (K061973)Synthes (Usa)2006-09-11
SFX SNAP-FIT CROSS CONNECTOR (K062196)Depuy Spine, Inc.2006-09-11
CTC WORKSTATION, MODEL 2200 (K062229)Medical Diagnostic Technologies, Inc.2006-09-11
GLUCOSE HK NEW FORMULATION TEST SYSTEM (K062239)Roche Diagnostics Corp.2006-09-11
BIOPSY DIGIT-AM (K062039)Giotto USA, LLC2006-09-11
INFIBRA, MODEL 1200 (K061735)Global Dental Products, Inc.2006-09-08
SYNTHES LCP ANKLE ARTHRODESIS PLATES (K061940)Synthes (Usa)2006-09-08
MINI POWER CHAIR, MODEL MN 5000 (K062483)Line Ind.(Shanghai) Co., Ltd.2006-09-08
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML (K062206)Becton, Dickinson & CO2006-09-08
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM (K060333)Dialysis Services, Inc.2006-09-08
VPAP MALIBU WITH H2I (K062291)Resmed, Ltd.2006-09-08
MODIFICATION TO: ORLUS MINI SCREW (K052968)Ortholution Co., Ltd.2006-09-08
SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT (K061410)Zimmer Dental, Inc.2006-09-08
TIMESH SELF DRILLING SCREW (K062348)Medtronic Neurosurgery2006-09-08
ANTI-SNORING / SLEEP APNEA DEVICE (K061688)Tomed Dr. Toussaint GmbH2006-09-08
SUPERDIMENSION/BRONCHUS PREMIUM 2 (K062315)Superdimension, Ltd.2006-09-08
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. (K060700)Euroimmun Us, LLC2006-09-08
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K062522)Jiangsu Jaysun Glove Co., Ltd.2006-09-08
QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 (K061008)Quidel Corp.2006-09-08
FORMCORE DC, MODEL 28-700100 (K061664)J. Morita USA, Inc.2006-09-08
5F SHERPA ACTIVE NX GUIDE CATHETER (K062420)Medtronic Vascular2006-09-08
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE (K061835)Stryker Instruments2006-09-08
INCORIS AL (K062506)Sirona Dental Systems GmbH2006-09-08
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061591)Medtronic Sofamor Danek, Inc.2006-09-08
TRANSEAR BONE CONDUCTION HEARING AID (K062404)Ear Technology Corp.2006-09-08
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED (K061717)Zimmer Dental, Inc.2006-09-08
KLS MARTIN STERNAL TALON (K051165)KLS-Martin L.P.2006-09-07
PROXIS SYSTEM (K052523)Velocimed, Inc.2006-09-07
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM (K062048)Aesthera Corporation2006-09-07
CYL-FIL OXYGEN SYSTEM (K061785)Responsive Respiratory, Inc.2006-09-07
TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE WITH 3-METRE TUBING, DOUBLE (K060182)Australian Surgical Devices2006-09-07
ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465)Bausch & Lomb, Inc.2006-09-06
PHILIPS MP5 INTELLIVUE PATIENT MONITOR (K062392)Philips Medizin Systeme Boeblingen GmbH2006-09-06
SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) (K061394)Busse Hospital Disposables, Inc.2006-09-06
URYXXON RELAX URINE ANALYZER (K061742)Macherey-Nagel GmbH & Co. KG2006-09-06
XCELERA (K061995)Philips Medical Systems North America Co.2006-09-06
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (K062316)Dade Behring, Inc.2006-09-06
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 (K061884)Bovie Medical2006-09-06
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE (K060623)Cook Ireland, Ltd.2006-09-06
ART LAB SOFTWARE (K061961)Pie Medical2006-09-06
AIE REGION OF INTEREST IMAGE ENHANCEMENT (K062059)Advanced Image Enhancement2006-09-06
GATEWAY THORACOLUMBAR PLATE SYSTEM (K062407)Globus Medical, Inc.2006-09-06
BIOSET XC (K060180)Regeneration Technologies, Inc.2006-09-06
SYNTHES OC FUSION SYSTEM (K053418)Synthes Spine Co.Lp2006-09-06
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR (K062067)Shen Wei (Usa), Inc.2006-09-06
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) (K062034)Dade Behring, Inc.2006-09-06
MEDGRAPHICS ULTIMA SYSTEM (K061731)Medical Graphics Corp.2006-09-06
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (K062042)Plethora Solutions2006-09-06
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH (K061825)Dade Behring, Inc.2006-09-06
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (K062199)Dade Behring, Inc.2006-09-06
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES (K061663)Rtc Inc.-Memcath Technologies, LLC2006-09-06
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE (K053540)Intermedic Arfran, SA2006-09-06
MEDIBYTE, MODEL MP8 (K061764)Braebon Medical Corp.2006-09-06
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 (K060765)Hemocue AB2006-09-06
MEDTRONIC EXPORT XT CATHETER (K061958)Medtronic Vascular2006-09-05
REPROCESSED EXTERNAL FIXATION DEVICE (K061759)Ascent Healthcare Solutions2006-09-05
PILOT POSTERIOR LUMBAR PLATING SYSTEM (K061364)Life Spine2006-09-05
PULSE OXIMETER, MODEL PM-50 (K061442)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-09-05
LIFESOUND ESOPHAGEAL STETHOSCOPE (K062020)Novamed, LLC2006-09-05
CORONIS COLOR 3MP AND MDCC 3120-DL (K061927)Barcoview2006-09-05
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) (K060734)Fresenius Medical Care North America2006-09-05
CORONIS 3MP AND MDCG 3120-CB (K061924)Barcoview2006-09-05
IMAX 9.5 STERILIZERS (K052532)Dental X Srl2006-09-05
LAPDOC I (K061224)Robodent GmbH2006-09-05
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 (K062281)Zimmer Dental, Inc.2006-09-05
PORTRAIT PSR3 (K060948)Rhytec Incorporated2006-09-05
CORONIS COLOR 2MP AND MDCC 2121 (K061928)Barcoview2006-09-05
INVACARE'S TWILIGHT II NASAL MASKS (K061874)Invacare Corp.2006-09-05
RB12 SUCTION RECTAL BIOPSY SYSTEM (K062159)Aus Systems Pty , Ltd.2006-09-05
AIRNERGY+STREAM (K052492)Natural Energy Solutions AG2006-09-05
MSD BIPOLAR FORCEPS (K061635)Medtronic Sofamor Danek2006-09-05
CERAMAX (K062504)Alphadent Co., Ltd.2006-09-05
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 (K061960)Cas Medical Systems, Inc.2006-09-05
MULTILINK SPRINT (K061781)Ivoclar Vivadent, Inc.2006-09-05
HEMOSIL LIQUID ANTITHROMBIN (K062431)Instrumentation Laboratory CO2006-09-01
GE VANTAGE PET NEURO SOFTWARE (K062393)GE Healthcare2006-09-01
BOOMERANG WIRE (K061075)Cardiva Medical, Inc.2006-09-01
SM IMPLANT SYSTEMS (K061797)Dio Department Dsi, Inc.2006-09-01
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH (K061649)Power Medical Interventions, Inc.2006-09-01
AGFA MODEL CR30-X (K062223)Agfa Corporation2006-09-01
HEMOSIL PROTEIN C (K062430)Instrumentation Laboratory CO2006-09-01
MODIFICATION TO NUVASIVE SPHERX II SYSTEM (K062317)Nuvasive, Inc.2006-09-01
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS (K062307)Anulex Technologies, Inc.2006-09-01
EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES (K061134)Efs Eberle Feinwerktechnische Systeme2006-09-01
AXYAFLEX POLYESTER SUTURE (K060165)Axya Medical, Inc.2006-09-01
EXCEL BOND DC, MODEL 28-200100 (K060882)J. Morita USA, Inc.2006-09-01
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) (K062290)Dade Behring, Inc.2006-09-01
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD (K061564)Portland Orthopaedics Pty. , Ltd.2006-09-01
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE (K062326)United States Surgical, A Division of Tyco Healthc2006-09-01
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS (K060288)Spire Biomedical, Inc.2006-09-01
WELLFLEX BILIARY RX STENT SYSTEM (K061231)Boston Scientific Corp2006-09-01
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Every clearance here is in the API, with alerts when new ones post.