Atlas FDA

2004

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

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RecordFirmDate
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K031142)Shanghai Palomar Mountain Industries, Inc.2004-03-17
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 (K032671)Gebauer Co.2004-03-17
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM (K030624)Draeger Medical, Inc.2004-03-17
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (K033291)Radi Medical Systems AB2004-03-17
CAAS II RVA (K033920)Pie Medical Imaging BV2004-03-17
COLLAGEN DENTAL WOUND DRESSINGS (K033729)Collagen Matrix, Inc.2004-03-17
PLV CONTINUUM VENTILATOR, MODEL P2000 (K034032)Respironics California, Inc.2004-03-16
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K034012)Smith & Nephew, Inc.2004-03-16
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR (K040503)Wrp Asia Pacific Sdn. Bhd.2004-03-16
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K040550)Orbus Medical Technologies2004-03-16
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER (K040492)Boston Scientific Corp2004-03-16
ZILVER 635 BILIARY STENT (K040505)Cook, Inc.2004-03-16
POWERLITE 600 EX SYSTEM (K033933)Preswede AB2004-03-16
CORRESTORE PATCH SYSTEM (K040162)Somanetics Corp.2004-03-16
ANSPACH ADVANCED MICRO SAW ATTACHMENTS (K040076)The Anspach Effort, Inc.2004-03-15
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS (K040286)Ethox Corp.2004-03-15
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE (K040472)Teleflex Medical2004-03-15
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS (K040298)Acist Medical Systems, Inc.2004-03-15
APEX NRG (K032743)Medicnrg , Ltd.2004-03-15
SERRALAPG (K033762)Serral, S.A. DE C.V.2004-03-15
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES (K034052)Latexx Manufacturing Sdn.Bhd.2004-03-15
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING (K040355)Gish Biomedical, Inc.2004-03-15
RESTFUL NIGHTS, IST-APPLIANCE (K021569)Ottawa Dental Laboratory2004-03-15
COLTOLUX LED CURING LIGHT (K040551)Coltene/Whaledent, Inc.2004-03-15
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (K033944)Stelkast Company2004-03-12
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS (K033919)Ciba Vision Corporation2004-03-12
IMAGE MANAGEMENT SYSTEM (K033870)Welch Allyn, Inc.2004-03-12
RFS VACUUM GAUGE SCAVENGING CIRCUIT (K033503)Accutron, Inc.2004-03-12
MODIFICATION TO ORIA TOP CLIP SYSTEM (K040346)Ortho Tec, LLC2004-03-12
INVACARE POLARIS EX CPAP, MODEL ISP3000 (K031064)Invacare Corp.2004-03-12
SINON POWER WHEELCHAIR, SN-P401 (K040320)Sinon Corporation2004-03-12
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR (K032936)Stanbio Laboratory2004-03-12
ENDOFLEX TRACHEAL TUBE (K031794)Merlyn Associates, Inc.2004-03-12
EMU128S, MODEL EX-NW-128S (K040360)Excel Tech. , Ltd.2004-03-12
TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE (K040112)Tri-Med, Inc.2004-03-12
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM (K040022)Stryker Leibinger2004-03-12
IMMUNICON CELLTRACKS AUTOPREP SYSTEM (K040077)Immunicon Corp.2004-03-12
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 (K040447)Boston Scientific Corp2004-03-12
RANDOX LIQUID CRP CONTROLS (K040351)Randox Laboratories, Ltd.2004-03-12
SPECTRUM MODULAR SYSTEM (K033893)DePuy Orthopaedics, Inc.2004-03-12
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS (K040295)Applied Medical Resources Corp.2004-03-12
KAEN YIH UMBILICAL CORD CLAMP (K033846)Kaen Yih Enterprise Co., Ltd.2004-03-11
PROGREAT (K033913)Terumo Medical Corp.2004-03-11
ATH FEMORAL STEM (K034028)Wrightmedicaltechnologyinc2004-03-11
WBR-FHR, WBR-FWB (K040370)Ultraspect , Ltd.2004-03-11
MEDIPACS (K040486)Neobit Co., Ltd.2004-03-11
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE (K033351)Global Orthopaedic Technology, USA, Inc.2004-03-11
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE (K040106)Becton, Dickinson & CO2004-03-11
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K040453)Revivant Corp.2004-03-11
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 (K033894)Matsushita Electric Works, Ltd.2004-03-11
VITALAB AMYLASE REAGENT (K040534)Clinical Data, Inc.2004-03-11
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX (K033177)Gunter Bissinger Medizintechnik GmbH2004-03-11
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 (K033876)Dolphin Medical, Inc.2004-03-11
NAVIPRO KNEE SOFTWARE MODULE (K033668)Kinamed, Inc.2004-03-11
EL-ANA PROFILES: ANTI-CHROMATIN (K040291)Theratest Laboratories, Inc.2004-03-11
FREELITE HUMAN KAPPA AND LAMBDA KITS (K040009)The Binding Site, Ltd.2004-03-11
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS (K040280)Roche Diagnostics Corp.2004-03-11
FLIGHT SOCK (K040353)Ssl Americas, Inc.2004-03-11
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000)Clinical Data, Inc.2004-03-10
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 (K040471)Olympus America, Inc.2004-03-10
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434)Roche Diagnostics Corp.2004-03-10
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K032803)Datex-Ohmeda2004-03-10
VIDAPORT INTRAOSSEOUS INFUSION SYSTEM (K032885)Vidacare Corporation2004-03-10
POGS 33 (K030920)On Site Gas Systems, Inc.2004-03-10
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431)Roche Diagnostics Corp.2004-03-10
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER (K033080)Portex, Inc.2004-03-10
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 (K033518)Custom Plastic Products2004-03-10
RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 (K034046)Rnk Products2004-03-10
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435)Roche Diagnostics Corp.2004-03-10
ORAVIVE TOOTH REVITALIZING PASTE (K040473)Novamin Technology, Inc.2004-03-10
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM (K030797)Resmed Corp2004-03-10
R&D GLU-LINE HEMATOLOGY CONTROL (K034048)R&D Systems, Inc.2004-03-10
LIQUICHEK CARDIAC MARKER CONTROL LT (K040277)Bio-Rad Laboratories, Inc.2004-03-10
STARLUX PULSED LIGHT SYSTEM (K033549)Palomar Medical Products, Inc.2004-03-10
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (K033921)Diagnostic Chemicals , Ltd.2004-03-10
ELECTRO-LUBE (K033880)Mectra Labs, Inc.2004-03-10
HEALTH BUDDY WITH BUDDYLINK (K040086)Health Hero Network, Inc.2004-03-10
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (K032932)Stanbio Laboratory2004-03-10
RESMED S8 PRIME CPAP SYSTEM (K033841)Resmed, Ltd.2004-03-10
MODIFICATION TO HRW-127 WRIST ARRAY COIL (K040349)Mri Devices Corp.2004-03-09
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE (K034059)Sectra AB2004-03-09
LACRYTEST (K034057)Adiatec SA2004-03-09
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE (K033496)Industrial Clothings, Ltd.2004-03-09
INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (K033807)Draeger Medical Systems, Inc.2004-03-09
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P (K033967)Flir Systems2004-03-09
SOHNIKS (K033191)Sohniks Endoscopy, Inc.2004-03-09
ULTRAFLEX INFUSION SET (K033892)Disetronic Medical Systems AG2004-03-09
VERSAPOINT RESECTOSCOPIC SYSTEM (K040302)Gynecare, A Div. of Ethicon, Inc.2004-03-09
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS (K040502)Siemens Medical Solutions USA, Inc.2004-03-09
STEERABLE STYLET (K040001)Synovis Surgical Innovations2004-03-09
BONESAVE BONE VOID FILLER (K033258)Howmedica Osteonics2004-03-09
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY (K033861)Becton, Dickinson & CO2004-03-09
ARROWHEAD SPINAL SYSTEM (K032560)Medtronic Sofamor Danek2004-03-09
PROFILE 1320 LASER SYSTEM (K032459)Sciton, Inc2004-03-09
THERILINK BONE VOID FILLER (K040134)Therics, Inc.2004-03-09
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL (K040348)Mri Devices Corp.2004-03-09
FLEBOSET MULTIPLE (K040456)Laboratorios Grifols, S.A.2004-03-09
SIREMOBIL ISO-C 3D (K040347)Siemens Medical Systems, Inc.2004-03-09
VITALAB URIC ACID REAGENT (K040467)Clinical Data, Inc.2004-03-08
AMEDITECH IMMU TEST DRUG SCREEN PANEL (K040092)Ameditech, Inc.2004-03-08
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Every clearance here is in the API, with alerts when new ones post.