Atlas FDA

2006

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

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RecordFirmDate
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K060227)Vision Biosystems, Inc.2006-05-25
MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR (K061303)Chi Lin Technology Co., Ltd.2006-05-25
40 L HIGH FLOW INSUFFLATOR F113 (K060723)W.O.M. World of Medicine AG2006-05-25
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE (K060324)Becton, Dickinson & CO2006-05-25
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES (K061074)Bright Element Sdn Bhd2006-05-24
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 (K061132)Neusoft Medical Systems Co., Ltd.2006-05-24
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT (K051442)Cynosure, Inc.2006-05-24
BC100 BODY COMPOSITION ANALYSIS SYSTEM (K060552)Athletic Iq, Inc.2006-05-24
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 (K053539)Baxter Healthcare Corporation2006-05-24
CARDIOFAX CE, MODEL ECG-1500 A (K052511)Nihon Kohden America, Inc.2006-05-24
MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 (K060977)Hoya Conbio, Inc.2006-05-24
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM (K061098)Ebi, L.P.2006-05-24
CONTACT LENS OPHTHALMODYNAMOMETER (K052674)Meditron, GmbH2006-05-24
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K060909)Jiangsu Everyguard Plastic Products Co., Ltd.2006-05-24
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K060805)Given Imaging , Ltd.2006-05-24
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (K060381)Renal Solutions, Inc.2006-05-24
BIO 1-KIT BIOSORB FILLED CARTRIDGE (K061022)Science For Biomaterials2006-05-24
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (K050367)Hyphen Biomed2006-05-24
SPACER-S TEMPORARY SHOULDER SPACER (K060535)Tecres S.P.A.2006-05-24
REPROCESSED ENDOSCOPIC TROCAR (K052299)Sterilmed, Inc.2006-05-23
DVTCARE CA5 (K061125)Doctors Orders2006-05-23
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 (K061072)Maquet Cardiopulmonary, AG2006-05-23
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES (K061175)Sota Precision Optics, Inc.2006-05-23
DENALI DEFORMITY SYSTEM (K052404)K2m, LLC2006-05-23
FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR (K061010)Future Mobility Healthcare, Inc.2006-05-23
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R (K061127)Medtronic Vascular2006-05-23
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES (K061192)Ethicon Endo-Surgery, LLC2006-05-23
ORTHOMON (K061113)Axon Systems, Inc.2006-05-23
7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L (K061273)Nova Ortho-Med, Inc.2006-05-23
VANTAGE INDIRECT OPHTHALMOSCOPE (K060822)Keeler Instruments, Inc.2006-05-23
TEMPFX ESTHETIC PROVISIONAL SYSTEM (K061264)Dentsply International, Inc.2006-05-23
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 (K060995)Duckworth & Kent, Ltd.2006-05-22
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M (K061112)Conmed Corporation2006-05-22
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. (K060530)Lifecore Biomedical, Inc.2006-05-22
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 (K061191)Measurement Specialties, Inc.2006-05-22
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 (K060649)Tyco Healthcare Group LP2006-05-22
CRYOSHAPE (K060928)Etgar Group H.M.Y.A. , Ltd.2006-05-22
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM (K061128)Medrad, Inc.2006-05-22
MONDIAL (K060994)Heraeus Kulzer, Inc.2006-05-22
MANI NEEDLE & SUTURE PACK (NYLON) (K053637)Mani, Inc.2006-05-19
TURKOM-CERA (K060860)Dental Suppliers of America, Inc.2006-05-19
ARTHREX BIO-COMPRESSION SCREW (K060478)Arthrex, Inc.2006-05-19
XIA TITANIUM AND 4.5 SPINAL SYSTEMS (K060979)Stryker Spine2006-05-19
AXSOS PLUS LOCKING PLATE SYSTEM (K061012)Howmedica Osteonics Corp.2006-05-19
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM (K060704)Zimmer, Inc.2006-05-19
MANI NEEDLE & SUTURE PACK (SILK) (K053638)Mani, Inc.2006-05-19
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES (K061078)Bright Element Sdn Bhd2006-05-19
ARGUS, MODEL LCM (K053207)Schiller AG2006-05-19
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 (K053337)Dade Behring, Inc.2006-05-19
SLEEP SPLINT (K060122)Nakagawa Dental Clinic2006-05-19
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM (K061118)Lifescan, Inc.2006-05-19
MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 (K060827)Esaote, S.p.A.2006-05-19
DEPUY SOLUTION SYSTEM HIP PROSTHESIS (K060581)DePuy Orthopaedics, Inc.2006-05-19
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA (K053552)<Genx> Intl., Inc.2006-05-19
TRIPOD (K060926)Freedom Designs, Inc.2006-05-19
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100 (K060240)K-Jump Health Co., Ltd.2006-05-19
LEGACY ABUTMENT SYSTEM (K060063)Implant Direct, LLC2006-05-19
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 (K061260)Intuitive Surgical, Inc.2006-05-18
3MATIC (K060950)Materialise NV2006-05-18
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES (K060821)Specialeyes, LLC2006-05-18
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 (K061063)Foxhollow Technologies, Inc.2006-05-18
TRABECTOME HIGH FREQUENCY GENERATOR/LP (K061258)Neomedix Corp.2006-05-18
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 (K060502)Dade Behring, Inc.2006-05-18
DIMENSION TACR CALIBRATOR, MODEL DC107 (K060503)Dade Behring, Inc.2006-05-18
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS (K053193)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-05-18
ENPATH MEDICAL STEERABLE SHEATH (K061119)Enpath Medical, Inc.2006-05-18
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND (K061259)Arthrocare Corp.2006-05-18
COSMATRIX (K060829)Tei Biosciences, Inc.2006-05-17
LAPIDUS PLATE (K060476)New Deal, S.A.2006-05-17
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 (K060880)Zimmer Dental, Inc.2006-05-17
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER (K060036)Smiths Medical MD, Inc.2006-05-17
TTC PLATE (K060473)New Deal, S.A.2006-05-17
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS (K050032)Euromed, Inc.2006-05-17
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE (K053579)Aesculap, Inc.2006-05-17
SINCLAIR ORAL RINSE (K053166)Sinclair Pharmaceuticals Limited2006-05-17
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES (K052691)Suretek Medical2006-05-17
XENFORM SOFT TISSUE REPAIR MATRIX (K060984)Tei Biosciences, Inc.2006-05-17
DEKNA-LOK MODEL BP1000V2L (K060801)Teleflex Medical2006-05-17
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM (K060412)Australian Surgical Design & Manufacture2006-05-17
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 (K061064)Beckman Coulter, Inc.2006-05-17
HAEMONETICS 40U RBC FILTER BAG (K061103)Haemonetics Corp.2006-05-17
MIDIVIEW SERIES OF MICROENDOSCOPES (K051073)Millennium Devices, Inc.2006-05-17
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM (K061048)Roche Diagnostics Corp.2006-05-17
HEMOHALT HEMOSTASIS PAD (K060409)Vanson-Halosource, Inc.2006-05-17
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT (K060388)Airway Management, Inc.2006-05-17
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) (K060724)Smart Glove Corp. Sdn Bhd2006-05-17
OPTYSE OPHTHALMOSCOPE (K061278)Ophthalmos , Ltd.2006-05-16
PROVIDE TEMPORARY CYLINDER (K061177)Implant Innovations, Inc.2006-05-16
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL (K060783)Trek Diagnostic Systems, Inc.2006-05-16
ABSOANCHOR MICROIMPLANT (K060126)Dentos, Inc.2006-05-16
TINNITUS PHASE-OUT (K061111)Tinnitus Control, Inc.2006-05-16
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF (K060775)Kossan Latex Industries(M)Sdn Bhd2006-05-16
MIM 4.0 (NEURO (K060816)Mimvista Corp.2006-05-16
TEMPORARY CROWN & BRIDGE RESIN (K060881)Cosmedent, Inc.2006-05-16
SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM (K061213)Medison Co., Ltd.2006-05-16
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS (K053230)Merits Health Products Co., Ltd.2006-05-16
MODIFICATION TO POWERHEART ECD (K060934)Cardiac Science Corporation2006-05-15
AVANZA (K060870)Mds Nordion2006-05-15
BISCEM TRANSLUCENT, BISCEM OPAQUE (K060701)Bisco, Inc.2006-05-15
USGI TRANSPORT ENDOSCOPIC GUIDE (K061216)Usgi Medical2006-05-15
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