Atlas FDA

2004

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

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RecordFirmDate
MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY (K033005)Barco NV Barcoview2004-04-19
ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE (K040876)Vital Images, Inc.2004-04-19
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 (K040509)Spire Biomedical, Inc.2004-04-19
SENOGRAPHIC STEREO (K040125)Ge Medical Systems, Inc.2004-04-19
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED (K032447)Linvatec Biomaterials, Ltd.2004-04-16
MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY (K033004)Barco NV Barcoview2004-04-16
MGD 2621L MEDICAL GREYSCALE DISPLAY (K033103)Barco NV Barcoview2004-04-16
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 (K032976)Biovalve Technologies, Inc.2004-04-16
FREEDOM HP (K040622)Freedom Designs, Inc.2004-04-16
KATALYST RADIAL HEAD IMPLANT (K032806)Kinetikos Medical, Inc.2004-04-16
PACKAGING TRAY AND COMPONENTS (K040707)Vygon Us, LLC2004-04-16
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (K040068)Ohmeda Medical2004-04-16
IM TOTAL FEMUR (K033871)Biomet, Inc.2004-04-16
INSTRUMED LAPAROSCOPE AND ACCESSORIES (K040855)Instrumed International, Inc.2004-04-16
EBI ESL SPINE SPACER SYSTEM (K040482)Ebi, L.P.2004-04-16
MICROVASCULAR ANASTOMOTIC DEVICE (K040163)Synovis Micro Companies Alliance, Inc.2004-04-16
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K040261)Stryker Spine2004-04-16
VARIANT II HEMOGLOBIN A1C (K040872)Bio-Rad Laboratories, Inc.2004-04-15
AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T (K040528)Ya Horng Electronic Co., Ltd.2004-04-15
EP DEFLECTABLE CATHETERS (K033963)Ep Medsystems, Inc.2004-04-15
PIGGYBACK IRRIGATING SYSTEM (K040094)Kosin Technologies, LLC2004-04-15
RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 (K033183)Curelight, Ltd.2004-04-15
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 (K023916)Bio-Medical Research, Ltd.2004-04-15
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM (K040814)Abbott Laboratories2004-04-15
ANSPACH MRI SAFE SURGICAL DRILL SYSTEM (K040186)The Anspach Effort, Inc.2004-04-15
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM (K040215)Vision-Sciences, Inc.2004-04-15
GE SIGNA 3.0T WITH EXCITE MR SYSTEM (K040444)General Electric Co.2004-04-14
ALTIUS OCT SYSTEM (K033961)Interpore Cross Intl.2004-04-14
FELCARE POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES (K040793)Hl Rubber Products Sdn Bhd2004-04-14
TERATECH MODEL 10V5 SMART PROBE (K040840)Teratech Corp.2004-04-14
MAYO CLINIC BC-10 3.0T (K040122)Mayo Clinic2004-04-14
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (K040415)Synovis Surgical Innovations2004-04-14
CARDIOVIT AT-102 (K031557)Schiller AG2004-04-14
MODIFICATION TO SURGICAL MESH POLYMERIC (K040787)Boston Scientific2004-04-14
SYNTHES MANDIBLE EXTERNAL FIXATOR (K040169)Synthes (Usa)2004-04-14
ACELL UBM SURGICAL MESH (K040621)Acell, Inc.2004-04-14
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS (K040331)Smith & Nephew, Inc.2004-04-14
INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE (K040188)Draeger Medical Systems, Inc.2004-04-14
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (K033186)King Systems Corp.2004-04-14
TELECARE D.R. SERVER SOFTWARE SYSTEM (K033133)Healthcare Vision, Inc.2004-04-13
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU (K033710)Fisher & Paykel Healthcare, Ltd.2004-04-13
INTERLOCKING DETACHABLE COIL SYSTEM (IDC) (K040342)Boston Scientific Corp2004-04-13
E-Z SCAN AB5500+ (K040668)Sonomed, Inc.2004-04-13
ORTHOCORD SUTURE (K040004)Depuy Mitek2004-04-13
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES (K040593)Zimmer, Inc.2004-04-12
NUVASIVE SPINAL SYSTEM (K033546)Nuvasive, Inc.2004-04-12
SYNTHES (USA) TIBIAL NAIL SYSTEM EX (K040762)Synthes (Usa)2004-04-12
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS (K040765)Synthes (Usa)2004-04-12
MEDSAFE SYSTEM INSERTER (K032848)Medsolve Technologies, LLC2004-04-12
VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER (K040285)Chattanooga Group2004-04-12
TALON INFUSION SET, MODEL IP XXXX (K033290)Icu Medical, Inc.2004-04-12
SCORPIO TOTAL KNEE SYSTEM (K033972)Howmedica Osteonics Corp.2004-04-12
MFCD 2320 (K040158)Barco N.V.2004-04-12
QUIESCENCE (K040330)Spectral Visualization & Development, Inc.2004-04-12
TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR (K031310)Tai Sheng Electrical Machinery Co., Ltd.2004-04-12
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM (K040336)Synthes (Usa)2004-04-12
OPTI-RIDER DELUXE (K033116)Hansung Econet Co., Ltd.2004-04-12
ART ANTERIOR SPINAL SYSTEM (K033148)Advanced Medical Technologies AG2004-04-12
CERAMIC TIPPED SKULL PIN (K040363)The Jerome Group, Inc.2004-04-12
LANX ANTERIOR CERVIAL PLATE SYSTEM (K040401)Lanx, LLC2004-04-12
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 (K040056)Bio-Detek, Inc.2004-04-09
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (K040773)Bionix Development Corp.2004-04-09
PARKELL RESIN GLAZE (K040599)Parkell, Inc.2004-04-09
FINE SURGICAL CIRCUMCISION CLAMP (K040052)Fine Surgical Instrument Corp.2004-04-09
HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT (K040714)Innova Corp.2004-04-09
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML (K033907)Becton, Dickinson & CO2004-04-09
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 (K040256)Bio-Detek, Inc.2004-04-09
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE (K033362)Becton, Dickinson & CO2004-04-09
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY (K033397)Avita Corporation2004-04-09
RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE (K040763)Resect Medical, Inc.2004-04-08
GEL MARK IV (K040706)Senorx, Inc.2004-04-08
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 (K040692)Olympus America, Inc.2004-04-08
BRACHYTHERAPY STRAND DEVICE (K040339)Bebig Isotopen-Und Medizintechnik GmbH2004-04-08
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 (K033157)Tanita Corp. of America2004-04-08
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD (K040644)DePuy Orthopaedics, Inc.2004-04-08
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE (K040133)Dade Behring, Inc.2004-04-08
CONVATEC FECAL MANAGEMENT SYSTEM (K032734)Convatec, A Bristol-Myers Squibb Co.2004-04-08
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C (K040061)Medtronic Minimed2004-04-08
MODIFICATION TO GEO STRUCTURE (K040168)Interpore Cross Intl.2004-04-08
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A (K033770)Isoaid, LLC2004-04-08
EASY MED TN-28 C (K040253)Easy Med Instrument Co., Ltd.2004-04-08
ONEVIEW INTERFACE (K040074)Nxstage Medical, Inc.2004-04-08
BLUEWAND LED DENTAL CURING WAND SYSTEM (K040614)J.L. Blosser, Inc.2004-04-07
MODIFICATION TO GE DISCOVERY LS SYSTEM (K040172)GE Medical Systems2004-04-07
CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM (K040195)Witt Biomedical Corp2004-04-07
BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES (K040643)Branemark Integration AB2004-04-07
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 (K040385)Quest Medical, Inc.2004-04-07
PHOENIX INFUSION CATHETER (K033017)Phoenix Biomedical2004-04-07
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569)Oscor, Inc.2004-04-07
DOSI-FUSER (K040752)Leventon, S.A.2004-04-07
BIOFREE (K033925)Dental Components, Inc.2004-04-07
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040619)Trek Diagnostic Systems, Inc.2004-04-07
PROTAB ECG TABB ELECTRODE (K040784)Bio Protech, Inc.2004-04-07
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (K040367)Electromed, Inc.2004-04-07
POLYLASE LP (K040055)Ddc Technologies, Inc.2004-04-07
YUE PFONG SAFETY SYRINGE (3ML) (K040105)Yue Pfong International Industrial Co., Ltd.2004-04-07
MASTERSCREEN CPX AND OXYCON CPX (K040698)Viasys Healthcare GmbH2004-04-07
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY (K040556)Eastman Kodak Company2004-04-07
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) (K033866)Lin-Zhi International, Inc.2004-04-07
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 (K040667)Abbott Laboratories2004-04-07
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Every clearance here is in the API, with alerts when new ones post.