Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CRANEX BASEX D OR CRANEX EXCEL D (K040382)Soredex Palodex Group OY2004-07-13
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A) (K041737)Totoku Electric Co., Ltd.2004-07-13
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY (K041221)Accu-Stat Diagnostics, Inc.2004-07-13
PHYSICIAN INDUSTRIES' DURAMETER SYRINGE (K033739)Physician Industries, Inc.2004-07-12
XPS 3000 SYSTEM (K041413)Medtronic Xomed, Inc.2004-07-12
DIAPHARMA FACTOR X KIT (K040362)Diapharma Group, Inc.2004-07-12
ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER (K033448)John Mfg., Ltd.2004-07-12
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574)Guidant Corporation2004-07-12
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE (K033858)European Custom Manufacturing BV2004-07-12
SHARPSAWAY II LOCKING DISPOSABLE CUP (K041153)Arrow Intl., Inc.2004-07-12
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K041391)Hartalega Sdn Bhd2004-07-09
PROFEMUR S HIP STEM (K041586)Wrightmedicaltechnologyinc2004-07-09
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) (K040281)DePuy Orthopaedics, Inc.2004-07-09
DDS-ZR (K041645)Charles Scharf2004-07-09
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A (K041454)Kyphon, Inc.2004-07-09
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES) (K040999)Procter & Gamble Co.2004-07-09
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) (K041738)Baxter Healthcare Corporation2004-07-09
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM (K041321)Richard Wolf Medical Instruments Corp.2004-07-09
BIOPORE BALLOON DILATION CATHETER (K041293)Bipore, Inc.2004-07-09
CORE NEEDLE BIOPSY (K040266)Remington Medical, Inc.2004-07-09
LEONARDO (K040970)Siemens Medical Systems, Inc.2004-07-08
KINETDX (K041029)Siemens Medi Cal Solutions, Inc.2004-07-08
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM (K031701)Osteomed LP2004-07-08
CRONO AND CRONO, MODEL 30 (K041414)Cane S.R.L.2004-07-08
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K041622)Draeger Medical, Inc.2004-07-08
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K040841)Medline Industries, Inc.2004-07-08
INJECTOR NEEDLE/SNARE (K040961)United States Endoscopy Group, Inc.2004-07-08
ACUMEN SURGICAL NAVIGATION SYSTEM (K031454)Biomet, Inc.2004-07-08
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 (K041688)General Electric Co.2004-07-08
MDI TRIGGER GUARD (K040439)North American Technical Services (Nats) Corp.2004-07-08
SYNTHES (USA) CHRONOS (K041350)Synthes (Usa)2004-07-08
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001 (K041101)Medical Adhesiveonline, LLC2004-07-07
DOVER RED RUBBER ROBINSON CATHETER (K041243)Tyco Healthcare2004-07-07
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 (K040007)Biomedical Life Systems, Inc.2004-07-07
COPSIOS BONE VOID FILLER (BVF) (K033679)Centerpulse Spine-Tech, Inc.2004-07-07
HOURGLASS VERTEBRAL BODY SPACER (K033926)Medtronic Sofamor Danek2004-07-07
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K040237)Intuitive Surgical, Inc.2004-07-07
MODIFICATION TO TRIPTER X-1 COMPACT DUET (K041582)Direx Systems Corp.2004-07-07
EXTRACTOR RX RETRIEVAL BALLOON (K041606)Boston Scientific Corp2004-07-07
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) (K041551)MicroVention, Inc.2004-07-07
ZIRCON-F PROPHYLAXIS PASTE (K040988)Pascal Co., Inc.2004-07-07
SUILE OINTMENT WOUND DRESSING (K041013)Hedonist Biochemical Technologies Co., Ltd.2004-07-07
KYPHX HV-R BONE CEMENT, MODEL C01A (K041584)Kyphon, Inc.2004-07-07
ACELL UBM SURGICAL MESH ML AND MLPLUS (K041140)Acell, Inc.2004-07-07
WATERLASE (K031140)Biolase Technology, Inc.2004-07-07
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS (K041608)Unilens Corp., USA2004-07-07
CMI MAGNETOCARDIOGRAPH (K033488)Cmi Cardiomag Imaging, Inc.2004-07-07
CADSTREAM VERSION 3.1 (K041020)Confirma, Inc.2004-07-07
3DKNEE POROUS COATED FEMORAL COMPONENT (K032905)Encore Orthopedics, Inc.2004-07-06
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (K041241)Alaris Medical Systems, Inc.2004-07-06
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL (K041561)Bio-Rad2004-07-06
BIS PEDIATRIC SENSOR (K041670)Aspect Medical Systems, Inc.2004-07-06
EBI XFIX DFS SYSTEM (K040935)Ebi, L.P.2004-07-06
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS (K040459)Biosite Incorporated2004-07-06
OPTIMESH 500E CEMENT RESTRICTOR (K033953)Spineology, Inc.2004-07-06
PTS PANELS LDL CHOLESTEROL TEST STRIPS (K040693)Polymer Technology Systems, Inc.2004-07-06
EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (K041416)Deroyal2004-07-02
H&S-CONDUCTIVITY STANDARD SOLUTION (K041636)H & S Technical Services2004-07-02
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133)Bayer Healthcare, LLC2004-07-02
GE VIVID 7 BT04 (K041552)General Electric Co.2004-07-02
NXSTAGE SYSTEM ONE (K041424)Nxstage Medical, Inc.2004-07-02
SOURCELINK (K041576)C.R. Bard, Inc.2004-07-02
STOCKERTIR PURGE CONTROL (APC) SYSTEM (K041558)Stockert Instrumente GmbH2004-07-02
ZILVER BILIARY STENT SYSTEM USW (K040930)Wilson-Cook Medical, Inc.2004-07-02
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) (K041004)Purna Bina Sdn Bhd2004-07-02
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (K040416)Philips Oral Healthcare, Inc.2004-07-02
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 (K041043)Pharmacia Deutschland GmbH2004-07-02
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE (K041325)Est International Corporation2004-07-02
MYSHELL (K040498)Sedat S.A.2004-07-02
VARILUX VISIONPRINT SYSTEM (VPS) (K033949)Essilor Intl.2004-07-02
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 (K041494)Olympus Corporation2004-07-01
CADWELL LIMB MOVEMENT MODULE (K040986)Cadwell Laboratories, Inc.2004-07-01
ATRICURE DISSECTOR (K041681)AtriCure, Inc.2004-07-01
DAVOL DELIVERY SYSTEM (K041641)C.R. Bard, Inc.2004-07-01
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT (K041656)DePuy Orthopaedics, Inc.2004-07-01
OMEGA 2 SYSTEM (K041001)Howmedica Osteonics Corp.2004-07-01
CD HORIZON SPINAL SYSTEM (K041460)Medtronic Sofamor Danek USA, Inc.2004-07-01
FAST START TENS, MODEL FS 3001 (K041092)Vision Quest Industries, Inc.2004-07-01
PERIPHERAL CUTTING BALLOON (K040155)Boston Scientific Corp2004-07-01
RESMED S8 PIONEER CPAP SYSTEM (K041209)Resmed, Ltd.2004-07-01
REVISION KNEE SYSTEM (K041106)Smith & Nephew, Inc.2004-07-01
ARTHREX SMALL FRAGMENT PLATES AND SCREWS (K040907)Arthrex, Inc.2004-07-01
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (K022823)Geister Medizin Technik GmbH2004-07-01
LIFEPAK 12 DEFIBRILLATOR/MONITOR (K041459)Medtronic Emergency Response Systems, Inc.2004-07-01
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 (K032937)Stereotaxis, Inc.2004-07-01
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT (K041449)Interpore Cross Intl.2004-07-01
MICROMESAM BASIC-SET (K040576)Map Medizintechnik Fur Arzt Und Patient GmbH2004-07-01
POWERHEART AED G3A (K040438)Cardiac Science, Inc.2004-07-01
ANKYLOS DENTAL IMPLANT SYSTEM (K040946)Friadent GmbH2004-07-01
RADIX CERVICAL PLATE (K033951)Pisharodi Surgicals, Inc.2004-07-01
ORTHOPEDIC ALLIANCE SPINE SYSTEM (K033826)Orthopedic Alliance, LLC2004-07-01
RADIAL NAIL SYSTEM (K040938)Wrightmedicaltechnologyinc2004-07-01
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (K041081)Hand Innovations, Inc.2004-07-01
EASYNET BODY POSITION MODULE (K040932)Cadwell Laboratories, Inc.2004-07-01
REFUGE SOUND GENERATOR (K041302)Micro-Ear Technology, Inc.2004-07-01
NASALCEASE (K041446)Les Laboratorires Brothier, S.A.2004-07-01
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) (K041466)Biomet Manufacturing Corp2004-07-01
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM (K040096)Spinal Concepts, Inc.2004-07-01
LPS (K033959)Depuy, Inc.2004-07-01
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K041556)Medtronic Sofamor Danek2004-07-01
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Every clearance here is in the API, with alerts when new ones post.