Atlas FDA

2007

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

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RecordFirmDate
NEOSS VARIOUS TITANIUM ABUTMENTS (K071838)Neoss, Ltd.2007-10-19
LTM-RC SURGICAL MESH (K071986)Lifecell Corp.2007-10-19
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE (K072016)Technomed Europe2007-10-19
MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR (K072516)Midmark Diagnostics Group2007-10-18
AEQUALIS REVERSED ADAPTER (K071948)Tornier2007-10-18
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS (K072050)Life-Tech, Inc.2007-10-18
TRU RSV (K071101)Meridian Bioscience, Inc.2007-10-18
REDSENSE (K071013)Redsense Medical AB2007-10-18
COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011)Copd Partners, Inc.2007-10-18
ALPHARD CONE BEAM CT, MODEL X178 (K072574)Takara Belmont Corp.2007-10-18
SYNOSS SYNTHETIC BONE GRAFT MATERIAL (K072397)Collagen Matrix, Inc.2007-10-18
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS (K070930)Sterilmed, Inc.2007-10-18
HDC STERILE SPIDER SCREW (K071851)Hdc S.R.L.2007-10-18
RESTORATION ADM SYSTEM (K072020)Howmedica Osteonics Corp.2007-10-18
PERFECT TISSUE CONTOURING SYSTEM II (K071632)Coltene/Whaledent, Inc.2007-10-18
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R (K071909)Barkey GmbH & Co. KG2007-10-18
MINRAD INC. NASAL SCAVENGING CIRCUIT (K072255)Minrad, Inc.2007-10-18
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (K072125)Ndo Surgical, Inc.2007-10-18
PULSION PICCO-2, MODEL 8500 (K072735)Pulsion Medical Systems AG2007-10-18
MODIFICATION TO PASSMED SPINAL SYSTEM (K070530)Medicrea Technologies2007-10-18
RAPHAEL COLOR ASV VENTILATOR (K071194)Hamilton Medical AG2007-10-18
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H (K072435)Dade Behring, Inc.2007-10-17
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 (K070438)Medtronic Minimed, Inc.2007-10-17
T-PORT HP INFUSION PORT (K071993)Pfm Medical, Inc.2007-10-17
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM (K072046)Brainlab AG2007-10-17
GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND (K072797)General Electric Co.2007-10-17
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT (K070405)Cook Biotech, Inc.2007-10-17
SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM (K072365)Siemens Medical Solutions USA, Inc., Ultrasound DI2007-10-17
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (K063145)Thermo Electron OY2007-10-17
NEUVIZ SPIRAL CT SCANNER SYSTEM (K072841)Neusoft Medical Systems Co., Ltd.2007-10-16
RESOLVE UVB PHOTOTHERAPY SYSTEM (K072035)Allux Medical2007-10-16
LIGHT SABRE SPINAL ACCESS DEVICE (K071814)Minrad, Inc.2007-10-16
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING (K071087)STERIS Corporation2007-10-16
REALHAND HIGH DEXTERITY INSTRUMENTS (K072715)Novare Surgical Systems, Inc.2007-10-16
QUIKCLOT EX (K072474)Z-Medica Corporation2007-10-16
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS (K072454)Integra Radionics, Inc.2007-10-16
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (K071049)Tyco Healthcare2007-10-16
SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, (K071382)Shinchang Medical Co., Ltd.2007-10-16
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (K070751)Isotis Orthobiologics, Inc.2007-10-15
MODIFICATION TO TRIATHLON TS KNEE SYSTEM (K072221)Howmedica Osteonics Corp.2007-10-15
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT (K072597)Wrightmedicaltechnologyinc2007-10-15
SMITH & NEPHEW ARTHROSCOPE (K072675)Smith & Nephew, Inc.2007-10-15
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B (K070195)Broadsound Corporation2007-10-15
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR (K072401)Xuzhou Full Sun Medical Products , Ltd.2007-10-15
PHENIX VERTEBRAL BODY REPLACEMENT (K072029)New Business Development, LLC2007-10-15
TRAVERSE OCT SPINAL FIXATION SYSTEM (K062447)Medtronic Sofamor Danek, Inc.2007-10-15
VITEK 2 GRAM POSITIVE VANCOMYCIN (K072668)bioMerieux, Inc.2007-10-15
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K063788)Ascent Healthcare Solutions2007-10-15
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES (K071888)Straumann USA2007-10-15
QUASAR BLUE LIGHT THERAPY SYSTEM (K072767)Silver Bay, LLC2007-10-15
PTS PANELS CHOL+HDL PANEL TEST STRIPS (K071593)Polymer Technology Systems, Inc.2007-10-15
AMNISCREEN HOME DETECTION LINER KIT (K071100)Common Sense , Ltd.2007-10-15
ACID ETCHED LAG SCREWS (K070955)Biomet Orthopedics, Inc.2007-10-12
SOUNMED COLOPOSCOPE COLPO-99/99PLUS (K070845)Sounmed, Inc.2007-10-12
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM (K070601)Intra-Lock International2007-10-12
ION DENTAL RESIN SYSTEM (K072713)Dentsply International, Inc.2007-10-12
ANGIOSCULPT PTA SCORING BALLOON CATHETER (K072225)Angioscore, Inc.2007-10-12
P.004 ABUTMENTS (K072679)Institut Straumann AG2007-10-12
VIS-U-ALL II SELF SEAL POUCH (K070765)STERIS Corporation2007-10-12
ACON UTI URINARY TRACT INFECTION TEST STRIPS (K063295)ACON Laboratories, Inc.2007-10-12
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR (K071713)Medical Decisions Network2007-10-12
GAMBRO CARTRIDGE BLOOD SETS (K070414)Gambro Renal Products2007-10-12
PIONEER LOWTOP SPINAL ROD SYSTEM (K072187)Pioneer Surgical Technology2007-10-12
CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) (K070212)Ovalum , Ltd.2007-10-12
MERCURY SPINAL SYSTEM (K071914)Spinal Elements, Inc.2007-10-12
VECTOR VISION HIP (K072716)Brainlab AG2007-10-12
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D (K071561)Beijing North Pole Dental Handpiece Co., Ltd.2007-10-12
SYNFIX-LR SPACER (K072253)Synthes Spine Co.Lp2007-10-12
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (K070146)Horiba Abx2007-10-12
VACU-MED BLOOD COLLECTION NEEDLES (K071947)Shina Corp.2007-10-12
PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)Innovative Spinal Technologies, Inc.2007-10-11
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE (K072295)Oridion Capnography, Inc.2007-10-11
VECTORVISION HIP AND HIP SR (K072573)Brainlab AG2007-10-11
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (K071934)Biomet Manufacturing Corp2007-10-11
INION BIORESTORE (K070998)Inion OY2007-10-11
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST (K070597)Nanosphere, Inc.2007-10-11
WIDE SPACED QUATTRODE LEADS (K072462)Advanced Neuromodulation Systems2007-10-11
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR (K070773)Axya Medical, Inc.2007-10-11
VIDAS B.R.A.H.M.S. PCT ASSAY (K071146)bioMerieux, Inc.2007-10-11
NAVIGATOR APPLICATIONS SUITE (K071097)GE Healthcare Finland Oy2007-10-10
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM (K071638)BioHorizons Implant Systems, Inc.2007-10-10
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 (K072113)Integra Lifesciences Corp.2007-10-10
CARDIOP-B SYSTEM, VERSION 2.1 (K072591)Paieon, Inc.2007-10-10
MIRAGE MICRO (K071808)Resmed, Ltd.2007-10-10
SHARPS AWAY DISPOSABLE CONTAINER (K072667)Solutions, Inc.2007-10-10
MASTERSCREEN & OXYCON CPX (K072323)Viasys Healthcare GmbH2007-10-10
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 (K071484)Glustitch, Inc.2007-10-10
MAGNETOM VERIO (K072237)Siemens Medical Solutions USA, Inc.2007-10-10
ARROW INTERNATIONAL, INC., SURGICAL DRAPES (K071491)Arrow Intl., Inc.2007-10-10
SCANSCOPE XT SYSTEM (K071128)Aperio Technologies2007-10-10
SKIN CARE LIGHT (K070870)Transverse Industries Co.2007-10-10
DCA VANTAGE, MODEL 5075 (K071466)Siemens Medical Solutions Diagnostics2007-10-09
PROBE HOLDER SYSTEM (K071405)Intuitive Surgical, Inc.2007-10-09
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES (K071621)Reliant Technologies, Inc.2007-10-09
TRIATHLON PKR SYSTEM (K071881)Howmedica Osteonics Corp.2007-10-09
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 (K071384)Nihon Seimitsu Sokki Co., Ltd.2007-10-09
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL (K063705)Thermo Electron OY2007-10-09
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 (K072087)Belimed Sauter AG2007-10-05
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH (K072117)Vascular Solutions, Inc.2007-10-05
SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM (K072546)Depuy Spine, Inc.2007-10-05
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Every clearance here is in the API, with alerts when new ones post.