Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK (K063356)Dade Behring, Inc.2007-03-23
K-Y BRAND WARMING LIQUID (K070545)Personal Products Co.2007-03-23
PET VCAR (K063324)GE Healthcare2007-03-23
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 (K061412)Thermo Electron Corp.2007-03-23
LINK TO ACUITY CLINICIAN NOTIFIER (K070204)Welch Allyn Protocol, Inc.2007-03-23
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K070097)Gx Corporation Sdn Bhd2007-03-23
CARDIOBELT ELECTRODE BELT (K063044)Monebo Technologies, Inc.2007-03-23
STRYKER T6 HOODS AND TOGAS (K063005)Stryker Instruments2007-03-23
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE (K063293)Edwards Lifesciences Services GmbH2007-03-23
PAINT- ON POLISH AGENT (K070306)Dentsply International, Inc.2007-03-22
FISSO HOLDING SYSTEM (K070509)Baitella AG2007-03-22
POWDERED (WHITE) VINYL PATIENT EXAMINATION (K070027)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-22
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB (K062014)Flaem Nuova S.P.A.2007-03-22
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 (K062282)Monebo Technologies, Inc.2007-03-22
RUIKE 3421 POWERED WHEELCHAIR (K070501)Shanghai Ruike Sports Goods Co., Ltd.2007-03-22
PORTI 7 PHYSIOLOGICAL AMPLIFIER (K063599)Tms International BV2007-03-22
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L (K070485)Cardiva Medical, Inc.2007-03-22
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (K062720)Richard Wolf Medical Instruments Corp.2007-03-22
HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL (K063568)Suzhou Medical Appliance Factory2007-03-22
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM (K063430)Stryker Spine2007-03-22
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 (K070134)Stockert GmbH2007-03-22
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (K063186)Zeus Scientific, Inc.2007-03-21
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP (K063043)Modern Healthcare Corp.2007-03-21
GENESIS DIODE LASER (K062258)Ivoclar Vivadent, Inc.2007-03-21
HASELMEIER PEN (K070100)Haselmeier Sarl2007-03-21
PERFORMER CBP SYSTEM (K070213)Rand S.R.L.2007-03-21
QUADRA BLOC TENS, MODEL 101 (K062547)Gradient Technologies, LLC2007-03-21
ALIGN URETHRAL SUPPORT SYSTEM (K070073)C.R. Bard, Inc.2007-03-21
ADVANCE SPIKED POROUS TIBIAL BASE (K063128)Wrightmedicaltechnologyinc2007-03-21
CLEARFIL MAJESTY ESTHETIC PLT (K070325)Kuraray Medical, Inc.2007-03-21
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K063663)Dade Behring, Inc.2007-03-21
MEMOMETAL FIXOS SCREWS (K070039)Memometal Technologies2007-03-21
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL (K063209)Thermo Electron OY2007-03-21
LMT-KATH-S; LMT-KATH-I (K062308)Licher Medizintechnologie GmbH2007-03-20
SPIROS (K070532)Icu Medical, Inc.2007-03-20
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K063627)Smart Glove Corp. Sdn Bhd2007-03-20
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 (K063347)Axis-Shield Diagnostics, Ltd.2007-03-20
C.T.M. MOBILITTY SCOOTER # HS-295 (K070603)C.T.M. Homecare Product, Inc.2007-03-20
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) (K070588)Philips Medical Systems2007-03-20
PERIPATCH ENDO-SLEEVE (K063556)Pm Devices, Inc.2007-03-20
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER (K063863)Advantage Medical Cables, Inc.2007-03-20
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) (K062919)Shen Wei (Usa), Inc.2007-03-20
ISIS (K070482)Galil Medical , Ltd.2007-03-20
ELECSYS PTH TEST SYSTEM (K070391)Roche Diagnostics Corp.2007-03-20
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS (K062873)E.C.I. USA Corporation2007-03-20
TOTAL ETCH BONDING AGENT (K063444)Dmg USA, Inc.2007-03-20
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER (K070011)Irvine Biomedical,Inc.(Ibi)2007-03-20
CONICAL ANGLED ABUTMENT (K063403)Implant Innovations, Inc.2007-03-20
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 (K070342)American I.V. Products, Inc.2007-03-19
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (K070420)United States Endoscopy Group, Inc.2007-03-19
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K063866)Bio-Rad Laboratories2007-03-19
POWDER FREE NITRILE BLUE EXAMINATION GLOVE (K061504)Liwe Trading2007-03-19
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP (K984204)Argentum International, LLC2007-03-19
TDM CONTROL SET, MODEL CAT# 04521536 (K070200)Roche Diagnostics Corp.2007-03-19
MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10 (K070033)Memometal Technologies2007-03-19
MEMOMETAL MEMORY STAPLES (K070031)Memometal Technologies2007-03-19
SILVERLON DIRECT PRESSURE WOUND DRESSING (K984207)Argentum International, LLC2007-03-19
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (K063150)Thermo Electron OY2007-03-19
REPROCESSED PHACOEMULSIFICATION TIPS (K060648)Alliance Medical Corp.2007-03-19
NIO 5MP-21 AND MDNG-5121 CB (K062621)Barcoview2007-03-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070188)Hong DI Plastic Products Co., Ltd.2007-03-19
SILVERLON ADHESIVE STRIP (K984205)Argentum International, LLC2007-03-19
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE (K063756)Dade Behring, Inc.2007-03-19
VARI-LASE BRIGHT TIP FIBER (K070216)Vascular Solutions, Inc.2007-03-16
ONDEMAND3D (K070464)Cybermed, Inc.2007-03-16
BIOMARC GOLD TISSUE MARKER (K070436)Carbon Medical Technologies, Inc.2007-03-16
POWERLED SURGICAL LIGHT SYSTEM (K070442)Maquet S.A.2007-03-16
VIDAR VISION 2000 (K070563)Vidar Systems Corp.2007-03-16
FUJINON MODEL EG-530N TRANS NASAL INSERTION (K063316)Fujinon, Inc.2007-03-16
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX (K070487)Volcano Corporation2007-03-16
BD HYPOINT NEEDLE (K070440)Becton, Dickinson & CO2007-03-16
ATRILAZE MI SURGICAL ABLATION SYSTEM (K061489)Medical Cv, Inc.2007-03-16
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K070214)Zimmer, Inc.2007-03-16
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) (K063432)Conformis, Inc.2007-03-16
LERADO, POWER WHEELCHAIR, PB (K070433)Lerado China Limited2007-03-16
XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 (DEN070004)Cepheid2007-03-16
PLASMACON N, PLASMACON L-1, PLASMACON L-2 (K062306)R2 Diagnostics, Inc.2007-03-16
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER (K062976)Ge Medical Systems Information Technologies2007-03-16
DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 (K063384)Hoya Conbio, Inc.2007-03-16
OXALATE URINE CONTROLS (NORMAL AND ELEVATED) (K062521)Thermo-Electron Corp.2007-03-16
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM (K062433)Diamics, Inc.2007-03-16
FREQUENCER, MODEL 1001 (K063645)Dymedso, Inc.2007-03-15
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (K070522)Inverness Medical Professional Diagnostics2007-03-15
SECURE ARTERIAL BLOOD SAMPLING SYSTEM (K070340)Smiths Medical Asd, Inc.2007-03-15
UNITIP HIGH RESOLUTION CATHETER (K062222)Unisensor AG2007-03-15
ADVACOAT SINUS GEL AND STENT (K070496)Carbylan Biosurgery2007-03-15
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K063581)Pt Mahakarya Inti Buana2007-03-15
EXACTECH NOVATION CROWN CUP AND LINERS (K070479)Exactech, Inc.2007-03-15
UNITY ALPHA SYSTEM (K062820)Bonutti Research, Inc.2007-03-15
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (K063490)Spacelabs Medical, Inc.2007-03-15
STRYKER FOOT PLATING SYSTEM (K063875)Howmedica Osteonics Corp.2007-03-15
REPROCESSED HEART STABILIZERS AND POSITIONERS (K063844)Sterilmed, Inc.2007-03-15
PROCHEM EXT CHEMICAL INTEGRATOR (K062651)Raven Biological Laboratories, Inc.2007-03-15
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 (K063210)Medtronic Inc. Cardiac Rhythm Management2007-03-15
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 (K070472)Taidoc Technology Corporation2007-03-15
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (K070448)Cardiomems, Inc.2007-03-15
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (K070048)Marian Medical, Inc.2007-03-15
MORTARA ELI 10 ELECTROCARDIOGRAPH (K070539)Mortara Instrument, Inc.2007-03-15
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES (K070072)Medtexx Manufacturing Sdn. Bhd.2007-03-15
ALPHA BIO DENTAL IMPLANT SYSTEM (K063364)Alpha-Bio Tec , Ltd.2007-03-14
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