Atlas FDA

2006

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

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RecordFirmDate
BLUE POWDER FREE NITRILE EXAMINATION GLOVES (K052583)Hartalega Sdn Bhd2006-06-14
DAN MONOPOLAR LAP ACCESSORIES (K052759)Dannoritzer Medizintechnik GmbH & Co. KG2006-06-14
SIGMA 5000 SERIES, IMAGIC (K061437)Kontron Medical Systems Sas2006-06-14
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING (K060630)Smith & Nephew, Inc.2006-06-14
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES (K061211)Zimmer GmbH2006-06-14
ENDOTOOL DRUG DOSE CALCULATOR (K053137)MD Scientific, LLC2006-06-14
DYNATRON ION IONTOPHORESIS ELECTRODE (K060814)Dynatronics Corp.2006-06-14
GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS (K061007)Good Medy Enterprise , Ltd.2006-06-14
ASTROTILT MANUAL WHEELCHAIR (K061475)Pdg Product Design Group, Inc.2006-06-14
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U (K061403)Microlife Intellectual Property GmbH2006-06-14
CARINA HOME (K060705)Draeger Medical B.V.2006-06-14
ABBOTT AXSYM TROPONIN-I ADV (K060875)Abbott Laboratories2006-06-14
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR (K061296)Diazyme Laboratories2006-06-13
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER (K061051)Sicel Technologies, Inc.2006-06-13
EPILONG KIT FOR ANESTHESIOLOGY (K060311)PAJUNK GmbH Medizintechnologie2006-06-13
ICHEM 100 URINE CHEMISTRY ANALYZER (K060280)Iris International, Inc.2006-06-13
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 (K061255)Kyron Clinical Imaging, Inc.2006-06-13
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) (K061328)E-San Limited2006-06-13
DAI-R (K060141)Shl Medical, USA2006-06-12
EASY X-TRAC SYSTEM (K060691)A. Titan Instruments, Inc.2006-06-12
VERSA-DIAL HUMERAL HEAD PROSTHESIS (K060716)Biomet Manufacturing Corp2006-06-12
ULTRATINE TRANSBLEPH (K060248)Coapt Systems, Inc.2006-06-12
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K052934)S.O.R. Internacional, S.A.2006-06-12
PALMLIGHT 10, MODEL 001-00030 (K061341)CAO Group, Inc.2006-06-12
ULTRATINE FOREHEAD (K060249)Coapt Systems, Inc.2006-06-12
OSOM INFLUENZA A&B TEST (K061508)Genzyme Corp.2006-06-12
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT (K061178)AngioDynamics, Inc.2006-06-12
EXACTECH EQUINOXE SHOULDER STEMS (K061454)Exactech, Inc.2006-06-12
SAFE TIP SYRINGE (K060668)Devon Safety Products, Inc.2006-06-12
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) (K060402)Brightway Holdings Sdn. Bhd.2006-06-09
CPIVISION DIGITAL IMAGING SYSTEM (K061173)Communications & Power Industries Canada, Inc.2006-06-09
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (K060896)Varian, Inc.2006-06-09
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 (K060766)Omron Healthcare, Inc.2006-06-09
SENTRY OTC MONITOR (K061088)Honeywell Hommed, LLC2006-06-09
GENESIS OTC MONITOR (K061087)Honeywell Hommed, LLC2006-06-09
M-VU CAD STATION (K061160)Vucomp, Inc.2006-06-09
TIPI (K060526)Contipi , Ltd.2006-06-09
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (K052197)W.H.P.M., Inc.2006-06-09
SOCKET GRAFT (K052493)Steiner Laboratories2006-06-09
UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) (K053172)Owandy Sas2006-06-09
ONLINE TDM TOBRAMYCIN (K060853)Roche Diagnostics Corp.2006-06-09
KOWA KT-800 (K053444)Kowa Co. , Ltd.2006-06-09
TRIDENT ANCHOR (K060914)Johnson & Johnson Company2006-06-09
AS101, BLOOD PRESSURE CUFF (K060871)Wenzhou Longwan Medical Instrument Company2006-06-09
GALILEOS IMPLANT, V 1.0 (K061472)Sicat GmbH & Co. KG2006-06-09
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC (K060686)Microlife Intellectual Property GmbH2006-06-09
DIACAP ULTRA DIALYSIS FLUID FILTER (K052764)B. Braun Medizintechnologie GmbH2006-06-09
MEDELA VARIO SUCTION PUMPS (K061435)Medela AG2006-06-08
ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. (K060916)Spinal Edge, LLC2006-06-08
DERMATECH IV HOLDER (K060488)Dermatech Medical, Inc.2006-06-08
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS (K060098)Ssl Americas, Inc.2006-06-08
KINSA SUTURE ANCHOR (K061154)Smith & Nephew, Inc.2006-06-08
LATEX POWDERED EXAMINATION GLOVE (K060858)High Momentum Sdn Bhd2006-06-08
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY (K061352)Smith & Nephew, Inc.2006-06-08
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 (K060537)Enginivity, LLC2006-06-08
SSP PEDICLE SCREW SYSTEM (K060118)Specialty Spine Products, LLC2006-06-08
RETAIN RADIOLUCENT SPACER (K061380)Globus Medical, Inc.2006-06-08
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (K061047)Hemocue AB2006-06-08
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT (K061144)DePuy Orthopaedics, Inc.2006-06-08
EBI ESL PEEK-OPTIMA SPINE SYSTEM (K061016)Ebi, L.P.2006-06-08
POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K060910)Jiangsu Everyguard Plastic Products Co., Ltd.2006-06-07
PRECISION THUNIS 800+ (K061028)Ge Medical Systems, LLC2006-06-07
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060 (K060820)Suntech Medical, Inc.2006-06-07
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML (K061355)Becton, Dickinson & CO2006-06-07
COHERENCE DOSIMETRIST, MODEL 2.2 (K061097)Siemens Medical Solutions USA, Inc.2006-06-07
BRIVANT GUIDEWIRE (K060551)Brivant Limited2006-06-07
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) (K061061)Tokotu Electric Co., Ltd.2006-06-07
GLUCOMMANDER PLUS (K061110)Collaborativemed, LLC2006-06-07
DUTECK BODY COMPOSITION ANALYZER (K060642)Duteck Industrial Co., Ltd.2006-06-07
TAG-IT CYSTIC FIBROSIS KIT (K060627)Tm Bioscience Corporation2006-06-07
QUIX DIGITAL RADIOGRAPHIC UPGRADE (K052661)Edge Medical Devices , Ltd.2006-06-07
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163)Ge Medical Systems, LLC2006-06-07
WIEDENT ESTETIC (K061337)Xpdent Corp2006-06-07
36MM BIOLOX DELTA CERAMIC HEADS (K061312)Biomet, Inc.2006-06-06
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 (K053033)Acro Biotech, LLC2006-06-06
MODIFICATION TO ENDIUS ATAVI SYSTEM (K061345)Endius, Inc.2006-06-06
SILKLINE SOFT RELINING KIT, MODEL 28-100100 (K060844)J. Morita USA, Inc.2006-06-06
CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C (K052798)Isovac Products, LLC2006-06-06
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 (K053034)Acro Biotech, LLC2006-06-06
VECTORVISION SPINE (K053159)Brainlab AG2006-06-06
ART BRACHYTHERAPY APPLICATOR (K060299)Advanced Radiation Therapy, LLC2006-06-06
STOCKERT HEATER-COOLER SYSTEM 3T (K052601)Sorin Group Deutschland GmbH2006-06-06
MUCOGRAFT (K061244)Ed. Geistlich Soehne AG Fuer Chemische Industrie2006-06-06
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS (K061019)Smith & Nephew, Inc.2006-06-06
CTS-7700 (K061083)Shantou Institute of Ultrasonic Instuments2006-06-06
K-SHIELD PORT ACCESS INFUSION SET (K060580)Kawasumi Laboratories, Inc.2006-06-06
MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR (K060693)Arthrotek, Inc.2006-06-06
FASTIN RC ANCHOR (K060664)Depuy Mitek2006-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 (K060632)Ortho-Clinical Diagnostics, Inc.2006-06-06
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. (K060201)Olympus America, Inc.2006-06-06
SERVICE MANAGER SM40SE (K053464)Conmed Integrated Systems, Canada, Ulc2006-06-06
LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM (K061384)Walter Lorenz Surgical, Inc.2006-06-06
HEMA SCREEN SPECIFIC IFOBT (K060463)Immunostics Inc.,2006-06-06
BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 (K060375)Bd Biosciences2006-06-06
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) (K060963)Twin Star Medical2006-06-06
WDS, SIZE 2 AND SIZE 2 (K061114)Cefla S.C.R.L.2006-06-06
CONFIDOSE IM AUTO-INJECTOR (K060389)Pharma-Pen, Inc.2006-06-06
TIGERVIEW PROFESSIONAL (K061035)Televere Systems2006-06-05
MODEL MI 44 TYMPANOMETER (K060885)Maico-Diagnostics2006-06-05
GE DATEX-OHMEDA ENGSTROM CARESTATION (K060862)Datex-Ohmeda, Inc.2006-06-05
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