Atlas FDA

2008

3,053 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BEAUTIFIL OPAQUER (K080068)Shofu Dental Corp.2008-02-28
Q-PLUS T (K073549)Quanta System Spa2008-02-28
EBI INTERNAL IMPLANT SYSTEM (K073116)Ebi, Inc.2008-02-28
ENVOYCEM, MODEL 1640 (K080032)Envoy Medical Corporation2008-02-28
CALCIUM, SCAL, NORTROL, ABTROL (K073355)Thermofisher Scientific OY2008-02-28
PETERIO UNIVERSAL LASER SCANNING HANDPIECE (K073048)Scilex, Ltd.2008-02-28
ELLMAN NOBLE ALLOY ELECTRODES (K071343)Ellman International, Inc.2008-02-28
EI DOWNPAK BARRIER SLEEVES (K073369)Hu-Friedy Mfg. Co., Inc.2008-02-27
APEX-LNK POLY ACETABULAR CUP LINERS (K073150)Omni Life Science, Inc.2008-02-27
ELECSYS PROBNP II CALCHECK (K080147)Roche Diagnostics Corp.2008-02-27
SOCT COPERNICUS, MODEL 15205 (K071839)Reichert, Inc.2008-02-27
GUARDIAN HEMOSTASIS VALVE (K073620)Zerusa Limited2008-02-27
15W CERALAS D 1470NM DIODE LASER (K073063)Biolitec, Inc.2008-02-27
HEARTWAY POWER MOBILITY SCOOTER, PF7 (K080242)Heartway Medical Products Co., Ltd.2008-02-27
CHARLOTTE CLAW 3.5 (K080295)Wrightmedicaltechnologyinc2008-02-27
C.T.M. POWER CHAIR, MODEL HS-1500 (K073686)C.T.M. Homecare Product, Inc.2008-02-27
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM (K073266)Boston Scientific Corp2008-02-27
QUIKCLOT NOSEBLEED (K080247)Z-Medica Corporation2008-02-27
VENA CAVA FILTER (K073528)Cook Incorporated2008-02-27
MEDICAL GLOVE SERIES (K072145)Zhanjiang Jiali Glove Products Co., Ltd.2008-02-26
1500 PRO (K080289)Omron Healthcare, Inc.2008-02-26
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR (K073561)Dade Behring, Inc.2008-02-26
LAVA FRAME, LAVA FRAME SHADE (K072055)3M Espe AG Dental Products2008-02-26
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (K080206)Radi Medical Systems AB2008-02-26
MICRUS MICROCOIL SYSTEMS (K073442)Micrus Endovascular Corporation2008-02-26
PHILIPS HEARTSTART SMARTPADS III (K072812)Philips Medical Systems2008-02-26
KIMBERLY-CLARK INTRODUCER KITS (K080253)Kimberly-Clark Corp.2008-02-26
MANDREL GUIDEWIRES OR M-WIRES (K080144)Lake Region Mfg., Inc.2008-02-26
CARDIQ EXPRESS VERSION 2.0 (K073138)GE Medical Systems2008-02-26
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (K080342)Nihon Kohden America, Inc.2008-02-26
CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338)Veridex, LLC2008-02-26
CARDIQ FUNCTION XPRESS (K073153)GE Medical Systems SCS2008-02-26
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 (K072860)Ya Horng Electronic Co., Ltd.2008-02-25
MINITAPE URETHRAL SLING (K073646)Mpathy Medical Devices, Ltd.2008-02-25
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 (K073046)Ethicon Endo-Surgery, Inc.2008-02-25
FORE-SIGHT, MC-2000 SERIES (K073036)Cas Medical Systems, Inc.2008-02-25
BIOMERIX SURGICAL MESH, MODEL: RCR-01 (K070961)Biomerix Corporation2008-02-25
FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322)A.R.C Laser GmbH2008-02-22
XVIEWNET (K080290)American Radiologist Network, Inc.2008-02-22
IMAGEGRID (K080333)Candelis, Inc.2008-02-22
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM (K073466)Smith & Nephew, Inc.2008-02-22
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (K073576)Harod Enterprises, Inc.2008-02-22
NOBELACTIVE ZIRCONIA ABUTMENT (K072129)Nobel Biocare AB2008-02-22
NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596)Neomed, Inc.2008-02-22
NONCON ROBO PACHY F&A (K062763)Konan Medical, Inc.2008-02-22
FOX 940, MODEL 940 (K071896)Valam, Inc.2008-02-22
ZIMMER MIS LIGHT (K080367)Zimmer Spine, Inc.2008-02-22
LEONE ORTHODONTIC MINI IMPLANT (K071490)Leone S.P.A.2008-02-22
ENSPLINTRX BONE FIXATION SYSTEM (K071809)Sonoma Orthopedic Products, Inc.2008-02-21
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR (K073516)Kyphon, Inc.2008-02-21
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES (K073460)Synthes (Usa)2008-02-21
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM (K073065)Osteomed LP2008-02-21
DEPUY TRI-LOCK BONE PRESERVATION STEM (K073570)DePuy Orthopaedics, Inc.2008-02-21
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072)Dade Behring, Inc.2008-02-21
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS (K073184)Bausch & Lomb, Inc.2008-02-21
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (K072988)Nipro Medical Corporation2008-02-21
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 (K080320)Nds Surgical Imaging2008-02-21
VINYL EXAMINATION GLOVE, POWDERED (K072223)Pinnacle Co., Ltd.2008-02-21
CLEARSCAN (K080119)Esi, Inc.2008-02-21
I-DIXEL (K073704)J. Morita USA, Inc.2008-02-21
AQUA PURE DEIONIZER EXCHANGE SERVICE (K072158)Staubach Barror Water Systems, Inc.2008-02-21
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (K070259)Bedfont Scientific, Ltd.2008-02-21
NEWDEAL TIBIAXYS SYSTEM (K073375)Newdeal Sas2008-02-21
HEANY INDUSTRIES INC DENTAL XIRCONIA (K073314)Heany Industries, Inc.2008-02-21
INSTARAD (K080334)Medsphere Technologies Pvt , Ltd.2008-02-21
POLYSTAR 79 DENTURE BASE RESIN (K072851)Cmp Industries, LLC2008-02-20
VITREA 4DCT (K072821)Vital Images, Inc.2008-02-20
GC GAM-100 (K073283)GC America, Inc.2008-02-20
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT (K072249)Medica Corp.2008-02-20
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX (K073232)Spinefrontier, Inc.2008-02-20
ALPHA INFUSION PUMP, MODEL A200, A450 (K071532)Advanced Infusion, Inc.2008-02-19
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM (K073426)Cayenne Medical, Inc.2008-02-19
UNICOMPARTMENTAL KNEE (K072704)Valpo Orthopedic Technology, Inc.2008-02-19
DVO EXTENDED ARTICULATION HUMERAL HEADS (K073331)Dvo Extremity Solutions, LLC2008-02-19
ORTHOPEDIATRICS PLATING SYSTEM (K073344)Orthopediatrics, LLC2008-02-19
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 (K071596)Nihon Seimitsu Sokki Co., Ltd.2008-02-15
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (K071702)Breas Medical AB2008-02-15
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS (K073067)Dentsply International, Inc.2008-02-15
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; (K080282)Arthrocare Corp.2008-02-15
VINYL EXAMINATION GLOVE POWDER FREE (K072227)Pinnacle Co., Ltd.2008-02-15
GC MODELS OPA-100 AND JC-50 (K073588)GC America, Inc.2008-02-15
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM (K073282)BioHorizons Implant Systems, Inc.2008-02-15
MODEL I-2000 MONITOR (K072382)Infinite Biomedical Technologies2008-02-15
3M ESPE ADULT CROWN (K072733)3M Company2008-02-15
HUAYI H035 BASIC WHEELCHAIR (K080114)Danyang Huayi Medical Supply & Equipment Co, Ltd.2008-02-15
SPI VARIOMULTI ABUTMENT (K072856)Thommen Medical AG2008-02-15
EXTENDED VERTIFLEX SPINAL SCREW SYSTEM (K073245)Vertiflex, Inc.2008-02-15
APEX DAL ELECTRONIC APEX LOCATOR (K080113)Medicnrg , Ltd.2008-02-15
VF GEL PLUS (K071663)Coapt Systems, Inc.2008-02-15
HOFFMANN LIGHT SYSTEM (K073076)Howmedica Osteonics Corp.2008-02-15
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114 (K080288)Mega Motion, Inc.2008-02-15
TRANSBOND SUPREME ADHESIVE (K073697)3M Unitek2008-02-15
GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE (K062991)Light Bioscience, LLC2008-02-15
PENTABORN (K072447)Mediscitec, Inc.2008-02-15
ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT (K073258)Atlantis Components, Inc.2008-02-14
THUMPER, MODEL: 1008 (K073079)Michigan Instruments, Inc.2008-02-14
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER (K070947)Intuitive Surgical, Inc.2008-02-14
BLACKSTONE ASCENT MULTIAXIAL SCREWS (K073420)Blackstone Medical, Inc.2008-02-14
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL (K073007)Barcoview, Medical Imaging Systems2008-02-14
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K080143)Stryker Spine2008-02-14
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Every clearance here is in the API, with alerts when new ones post.