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Home > 483 Reports > FDAnews Form 483s FDAnews Form 483s STORE BOOKS CONFERENCES NEWSLETTERS FORM 483s DVDs Apieron Issued: 8/28/09 Category: Device 483s Inspector(s): Timothy C. Grome SpineMatrix, Inc. Issued: 8/27/09 Category: Device 483s Inspector(s): Laureen M. Geniusz Rush Pin, LLC Issued: 8/27/09 Category: Device 483s Inspector(s): Amanda K. Willey, Sidney M. Smith Naviscan, Inc. Issued: 8/27/09 Category: Device 483s Inspector(s): Yvette E. Guillermo BD Medical Surgical Issued: 8/27/09 Category: Device 483s Inspector(s): Matthew J. Morrison, Julie N. Vosilus American Contract Systems, Inc. Issued: 8/27/09 Category: Device 483s Inspector(s): Rodney D. Combs Symbios Medical Products, LLC Issued: 8/26/09 Category: Device 483s Inspector(s): Charles M. Spyr Erickson Labs Northwest Issued: 8/26/09 Category: Device 483s Inspector(s): Catherine J. Laufmann Sleep Devices, Inc. Issued: 8/25/09 Category: Device 483s Inspector(s): Joshua J. Silvestri Clearwater Products, LLC Issued: 8/25/09 Category: Device 483s Inspector(s): Richard K. Vogel So-Low Environmental Equipment Co., Inc. Issued: 8/21/09 Category: Device 483s Inspector(s): Rosanna M. Vaccaro Lumenis, Inc. Issued: 8/21/09 Category: Device 483s Inspector(s): Bryan J. Love CAO Group, Inc. Issued: 8/21/09 Category: Device 483s Inspector(s): Neira Acevedo-Ramos, Thai Duong Premier Products Issued: 8/20/09 Category: Device 483s Inspector(s): Melissa I. Michurski, Darren D. Holiday SMT Health Systems, Inc. Issued: 8/19/09 Category: Device 483s Inspector(s): Melissa I. Michurski Nexcore Technology, Inc. Issued: 8/18/09 Category: Device 483s Inspector(s): Alberto A. Viciedo, Li Li General Econopak, Inc. Issued: 8/18/09 Category: Device 483s Inspector(s): Michael J Nerz Bard Access Systems Issued: 8/14/09 Category: Device 483s Inspector(s): Thai Duong Panoramic Corp. Issued: 8/13/09 Category: Device 483s Inspector(s): James E Frye Monster Medic, Inc. Issued: 8/13/09 Category: Device 483s Inspector(s): Michelle J. Glembin, Aaron L. Dunbar, Jeffry A. Bernhardt Go to page: 1234567891011121314151617181920212223242526272829303132333435363738394041424344454647 Previous123.........40.........454647Next

483s Search Search by Date Issued From To Search by Category Drug Manufacturers Device Manufacturers Search by Company- Please Select -220 Laboratories, Inc.3CPM Company, Inc.3M CompanyA & Z Pharmaceutical, Inc.A R Custom Medical Products, LtdA&Z Pharmaceutical, Inc.A-OX Welding Supply, Inc.A.I.G. Technologies, Inc.A.P. Deauville, LLCA.R. Medicom, Inc.ABBE Laboratories, Inc.ABC Compounding Company, Inc.ABL Manufacturing, LLCAL&S, LLCALK Abello A/SAMCO International Manufacturing & Design, Inc.AMO Puerto Rico Manufacturing, Inc.AMPAC Fine Chemicals, LLCANIP Acquisition, Inc.API, Inc.APP Pharmaceuticals, LLCARJ Medical, Inc.ASI Marketing Group, LLCASI Medical, Inc.ASO, LLCAVEVA Drug Delivery Systems, Inc.Aaron Industries, Inc.Abaxis, Inc.Abba Pharma, Inc.Abbey Color, Inc.Abbott Diabetes Care, Inc.Abbott Diagnostics International Ltd.Abbott Diagnostics International, Ltd.Abbott Laboratories, Inc.Abbott MolecularAbbott Molecular, Inc.Abbott Pharmaceuticals PR, Ltd.Abbott Point of Care, Inc.Abbott Vascular, Inc.Abc Compounding Company, Inc.Access Bio, Inc.AccessClosure, Inc.Accumed, Inc.Accupac, Inc.Accuray, Inc.Acra Cut, Inc.Acra cut, Inc.Actavis Elizabeth, LLCActiTech, LPActigraph, LLCAcuLux, Inc. Acuderm, Inc.Ad-Tech Medical Instrument Corp.AdDent, Inc.Adhesives Research, Inc.Advance Pharmaceutical, Inc.Advanced Imaging Research, Inc.Advanced Medical Instruments, Inc. Advanced Medical Isotope Corp.Advanced Medical Technologies AGAdvanced Monitored CaregivingAdvanced Neuromodulation Systems, Inc.Advanced Pharmaceutical, Inc.Advanced Rehabilitation TechnologiesAdvanced Renal Technologies, Inc.Advanced Skin Technologies, Inc.Advanced Sterilization Products, Division of Johnson & Johnson Medical, Inc.Advantageous Md, LLCAerocrine, Inc.Aerscher Diagnostics, LLCAerus, LLCAesculap, Inc.Afton Scientific Corp.Ag IndustriesAgropharma Laboratories, Inc.Aionex, Inc.Air Techniques, Inc.AirSep Corp.Aire-Master of America, Inc.Ajinomota Amino Science, LLCAkers Biosciences, Inc.Akorn, Inc.Akron Coating & Adhesives, Inc.Alarm Electronics Mfg. Co., Inc.Alcon Grieshaber AGAlcon Research, Ltd.Alex C. 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Products, Inc.American Laboratories, Inc.American National Mfg, Inc.American Peptide Company, Inc.American Red Cross Diagnostic Manufacturing DivisionAmerican Thermal Instruments, Inc.Ames Goldsmith Corp.Amgen Manufacturing Ltd., Inc.Amgen Manufacturing, Ltd.Amgen, Inc.Amicas, Inc.Amigo Mobility International, Inc.Amneal PharmaceuticalsAmneal Pharmaceuticals of New York, LLCAmpac Fine Chemicals, LLCAmphastar Pharmaceuticals, Inc.Amylin Ohio, LLCAmylin Pharmaceuticals, Inc.Anchor Products Company, Inc.Andapharm, LLCAnesthetic Gas Reclamation, LLCAngioScore, Inc.Angiodynamics, Inc.Angiologica B.M. srlAnika Therapeutics, Inc.Apheresis Technologies, Inc.ApieronApnea Sciences, Inc.Apotex Research Private Ltd.Apothecary Products, Inc.Applied Diabetes Research, Inc.Applied Laboratories, Inc.Applied Medical Technology, Inc.Applied Neuroscience, Inc.Applied Ozone SystemsApria Healthcare, Inc.Apter Industries, Inc.Apteryx, Inc.Aptuit, Inc.Aqueduct Medical, Inc.Aringer, Inc.Arkema, Inc.Arnold Tuber Industries dba ScidArnold Tuber Industries, LLCArrow Chemical Products, Inc.Arrow International, Inc.Artegraft, Inc.Arteriocyte Medical Systems, Inc.Arthrex, Inc.Ascension Orthopedics, Inc.Aseptico, Inc.Ash Stevens, Inc.Asthmatx, Inc.Atlas Spine, Inc.Aubrey Inc.Aubrey Organics, Inc.Audifon-USA, Inc.Augustine Biomedical & Design, LLCAurora Imaging Technology, Inc.Aus Systems Pty Ltd.AutoCenomics, Inc.Avid Bioservices, Inc.Avid Radiopharmaceuticals, Inc.Avinger Inc.Avon Products, Inc.Axelgaardf Manufacturing Company, Ltd.Axon Systems, Inc.B&G Labs, Inc.B. 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Benson Hood Laboratories, Inc.EDDA Technology, Inc.EMD Chemicals, Inc.ENDO Pharmaceuticals, Inc.Eagle Diagnostics, Inc.Eastern Cranial Affiliates, LLCEaton Manufacturing Corp.Eaton Manufacturing Corporation dba Eaton MedicalEdwards Lifesciences Technology SARLEidosmed, LLCElectric Mobility Corp.Electro Kinetic Technologies, LLCElectro-Cap International, Inc.Electro-Diagnostic Imaging, Inc.Electromedical Products International, Inc.Elge, Inc.Eli Lilly and CompanyElite Laboratories, Inc. Elixir Research, LLCEllman International, Inc.Emcure Pharmaceuticals USA, Inc.Emerald 3 Enterprises, Inc.Emerald Kalama Chemical, LLCEminent Spine, LLCEncision, Inc.Encompas Unlimited, Inc.Encompass Group, LLCEndogastric Solutions, Inc.EndoplusEndotec, Inc.Enthermics Medical Systems, Inc.Enzon Pharmaceuticals, Inc.Enzymatic Therapy, Inc.Enzyme Solutions, Inc.Epien Medical, Inc.Erickson Labs NorthwestErie Medical, division of Ocenco, Inc.Essex Cryogenics of Missouri, Inc.Estee Lauder, Inc. 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Inc.Guidewire Technologies, Inc.Gulf Medical Fiberoptics, Inc.Guy & O'Neill, Inc.H & P Industries, Inc.H&P IndustriesH2O Plus, L.P.HAI Laboratories, Inc.HMI Industries, Inc. HRC Laboratories dba Dynamic RemediesHaemonetics Corp.Haemoscope Corp.Hammill Manufacturing CompanyHanger Prosthetics & Orthotics, Inc.Hans Rudolph, Inc.Hansen Medical, Inc.Hard Manufacturing Company, Inc. Harmar Summit, LLCHarvest Technologies Corp.Hausser Scientific Co.Haven Innovation, Inc.Hawkeye Jansen, Inc.Hawkeye Jensen, Inc.Hawknad Manufacturing Industries, Inc.Hayward Laboratories, Inc.Healex Products, Inc.`Healing WaysHealth Advances USA, Inc.Health Line International Corp.Health Science Products, Inc. Healthcare Equipment & SupplyHealthline Medical Products, Inc.Heartsine Technologies, Inc.Heartware, Inc.Heavenly Harvest, Inc.Helena Laboratories, Inc.Hema Metrics, LLCHemcare of Oregon, Inc.Hemcon Medical Technologies, Inc.Hercon Laboratories Corp.Heritage Medical Products, Inc.Hi-Tech Pharmacal Co., Inc.Hi-Tech Pharmacal Co., Inc. Hill Dermaceuticals, Inc.Hitachi Chemical Diagnostics, Inc.Hitachi Medical Systems America, Inc.Hoffmann La Roche, Inc.Holland Company, Inc.Hologic, Inc.Home Medical Supply of Poplar Bluff, Inc.Horizon Pharmaceuticals, Inc.Hospira Boulder, Inc.Hospira Boulder, Inc. Hospira, Inc.Hospira, Inc. Hot Dog USA, LLCHoward Instruments, Inc.Howmedica Osteonics Corp.Hu-Friedy Mfg. Co., Inc.Human Biosciences, Inc.Human Genome Sciences, Inc.Humco Holding Group, Inc.Hurricane Medical, Inc.Hyaluron, Inc.Hydrogel Vision Corp.Hydrox Chemical Company, Inc.Hyperbaric Technologies, Inc.I Shay Cosmetics, Inc.I-Flow, LLCI2s Micro Implantable Systems, LLCIBA MolecularIBA Molecular North America, Inc.ICU Medical, Inc.ID Biomedical Corporation dba GlazoSmithKline BiologicalsIGI, Inc.IKI Mfg. Co., Inc.INO TherapeuticsIPR Pharmaceuticals, Inc.ISO Tex DiagnosticsISP Freetown Fine Chemicals, Inc.Idaho Technology, Inc.Imaging Biometrics, Inc.Immco Diagnostics, Inc.Impact Instrumentation, Inc.Impax Laboratories, Inc.Implantable DevicesInceptio Medical Technologies, LCIncisive, Inc.Industrial & Biomedical Sensors Corp.Industrial Municipal Equipment, Inc.Infimed, Inc.Innotech USAInnovative Med, Inc.Innovative Medical EquipmentInnovia, LLCInopak, Ltd.Inovise Medical, Inc.Insight Instruments, Inc.Insightra Medical, Inc.Instituto Bioclon S.A. de C.V.Integra LifeSciencies Corp.Integra Neurosciences PR, Inc.Integrated Biomedical Technology, Inc.Integrated Medical Devices, Inc.IntelliCell Biosciences, Inc.Intelligent Hearing Systems Corp.Interlectric Corp.Internal Fixation Systems, Inc.International Immuno-Diagnostics, Inc.International Medical Development Corp.Intersect ENT, Inc.Intersurgical, Inc.Interventional Spine, Inc.Intra-Lock InternationalIntravena, LLCInvaGen Pharmaceuticals, Inc.Invacare Corp.Invivo Corp.Irenda Corp.Iridex Corp.Irisys, Inc.Iso-Tex DiagnosticsIsolux, LLCIvoclar Vivadent, Inc.J F Labs, Inc.J R Rand Corp.J T Posey CompanyJ. Strickland and Co.JAS Diagnostics, Inc.JCF Engineering, Inc.JFC TechnologiesJHP Pharmaceuticals, LLCJK Products & Services, Inc.JWP & Associates, Inc.Jacobus Pharmaceutical Co., Inc.James Alexander Corp.James Consolidated, Inc.James E. Shenberg, D.D.S., Inc. dba TherozoneJanssen Biotech, Inc.Janssen Ortho, LLCJanssen-Cilag Manufacturing, LLCJerome Stevens Pharmaceuticals, Inc.Jeropa Swiss Precision, Inc.Johnson & Johnson Merck ConsumerJohnson & Johnson Pharmaceutical Research & Development, LLCJohnson Creek Enterprises, Inc.Johnson Laboratories, Inc.Johnson Matthey Pharma ServicesJubilant Cadista Pharmaceuticals, Inc.June Jacobs Labs, LLCK C Pharmaceuticals, Inc.KBD, Inc.KDS NailKP Pharmaceutical TechnologyKT Medical, Inc.KV Pharmaceutical Co.KVK-Tech, Inc.Kapp Surgical Instrument, Inc.Karl Storz GMBH & Co. KGKarl Storz Video Endoscopy Estonia OuKasios Bone SubstitutesKaypentaxKedrion S.p.A.Keller LaboratoriesKem Medical Prod Corp.Kem Tech Chemical CompanyKendall, a division of TycoHealthcare Group LPKenwick, Inc.Kerma Medical Products, Inc.Kerr Corp.Keystone Laboratories, Inc.Kimball Electronics TampaKing Pharmaceuticals, IncKing Systems Corp.Kirk Pharmaceuticals, LLCKlinge Chemicals, Ltd.Knoll, LLC (dba Abbott Laboratories, Inc.)Knoll, LLC dba Abbott LaboratoriesKonsyl Pharmaceuticals, Inc.Koros USA, Inc.Kova Laboratories, Inc.Kramer DetergentsKremers Urban Pharmaceuticals, Inc.Kub TechnologiesKutol Products Co.Kutol Products Co., Inc.L'Oreal USA Products, Inc.L. Perrigo Co.LAR Manufacturing, LLCLCR-Hallcrest, LLCLED Technologies, LLCLNK International, Inc.LTS Lohmann Therapy Systems Corp.Lab Vision Corp.Laclede, Inc.Lacrimedics, Inc.Lannett Company, Inc.LaserSight Technologies, Inc. dba TechniLaserLechnologies Research, Inc.Lee Pharmaceuticals, Inc.Lehigh Valley Technologies, Inc.Levitronix, GmbHLevlad, LLCLex, Inc.Lexington International, LLCLibby Laboratories, Inc.Lidco, Ltd.Life-Tech, Inc.Lifeline Systems, Inc.Lifetech Resources, LLCLifewatch Services, Inc.Lilly del Caribe, Inc.Limerick, Inc.Lin-Zhi International, Inc.Lincare, Inc.Linde Gas Puerto Rico, Inc.Linet Spol. S.r.o.Linvatec Corp.Lisa Laser Products OHGLloyd, Inc. of IowaLone Star Medical Products, a CooperSurgical CompanyLonza, Inc.Lornamead Brands, Inc.Lucero Medical, LLC Luitpold Pharmaceuticals, Inc.LumaSense TechnologiesLumen Photon Therapy, Inc.Lumenis, Inc.LumiQuick Diagnostics, Inc.Luna Innovations, Inc.Lyne Laboratories, Inc.M.D.R. Fitness Corp.MAC MedicalMEAS US, LLCMEDICAMAT S.A.MEM, Inc.MIM Software, Inc.MOOG Medical Devices GroupMP Biomedicals Diagnostics DivisionMPM Medical, Inc.MSD International GMBH (Puerto Rico Branch), LLCMalem MedicalMallinckrodt, Inc.Maloney's Custom Ocular ProstheticsMana Products, Inc.Mannkind Corp.Maple Industries, LLCMaquet Cardiovascular, LLCMarCal MedicalMarcus Research Labs, Inc.Marina Medical Instruments, Inc.Marlen Manufacturing & Development Co.Marlin Company, Inc.Massco DentalMatech, Inc.Materialise USA, LLCMcNeil Consumer HealthcareMcNeil Consumer Healthcare, Div. of McNeil-PPC, Inc.McNeil Healthcare, LLCMcPherson Enterprises, Inc. dba Implantable DevicesMecta Corp.Med Torque, Inc.Med-DyneMed-Hot Thermal Imaging, Inc.MedImmune Vaccines, Inc.MedImmune, LLCMedMira Laboratories, Inc.MedX Limited Corp.Meda Pharmaceuticals, Inc.Medefil, Inc.Medela, Inc.Medi Physics, Inc. dba GE Health Care, Inc.Mediana Technologies Corp.Medical Accessories, Inc.Medical Concepts, Inc.Medical Depot, Inc.Medical Equipment Device SpecialistsMedical Instrumentation & Diagnostics Corp.Medical Laser Systems, Inc.Medical Products Laboratories, Inc.Medical Quant USAMedical Supplies Corp.Medical Technology, Inc.Medical Technology, Inc. Medivation, Inc.Mediwatch UK Ltd.Medrad, Inc. d.b.a. Pathway Medical Technologies, Inc.Medro Systems, Inc.Medrx, Inc.Medspring Group, Inc.Medtronic Ablation Frontiers, LLCMedtronic Navigation, Inc.Medtronic Puerto Rico Operations Co.Medtronic Spine LLC, formerly Kyphon, Inc.Medtronic, Inc.Megadyne Medical Products, Inc.Melaleuca, Inc.Mercedes Medical, Inc.Merck & Company, Inc.Merck Sharp & Dohme Corp.Mericon Industries, Inc.Meridian Medical TechnologiesMeridian Medical Technologies, Inc.Merit Medical Systems, Inc.Metrics, Inc.Mick Radio Nuclear Instruments, Inc.Micro Surgical Technology, Inc.Micro Tool Engineering, Inc.Micro Typing Systems, Inc.Microfit, Inc. Micron Technologies, Inc.Micrus Endovascular Corp.Midmark Corp.Milbar Laboratories, Inc.Milestone Scientific, Inc.Millar Instruments, Inc.Millennium Pharmaceuticals, Inc.Millstone Medical Outsourcing, LLCMindray North AmericaMini Lap Technologies, Inc.Minntech Corp.Mission Pharmacal Co. Mizuho Orthopedic Systems, Inc.Mobius Therapeutics, LLCMolteno Opthalmic Ltd.Monster Medic, Inc.Morton Grove Pharmaceuticals, Inc.Morton Salt InternationalMountain Meadow HerbMova Pharmaceutical Corp.Mueller Water Conditioning, Inc.Multi-Med, Inc.Mycone Dental Supply Co., Inc.Myerson, LLCMylan Pharmaceuticals, Inc.Mylan, Inc.N K Medical Products, Inc.N.M. Beale Company, Inc.NDI Medical, Inc.NDS Surgical Imaging, LLCNatural Essentials, Inc.Naturich Labs, Inc. Naturopatch of Vermont, Inc.Natus Europe GmbHNavilyst Medical, Inc.Naviscan, Inc.Needletech Products, Inc.Neo Imagery Technologies, Inc.NeoMPS, Inc.Neochild, LLCNeoprobe Corp.Neos Therapeutics, Inc.Neoteric Cosmetics, Inc.Nephron Pharmaceuticals Corp.Netech Corp.NeuroVasix, Inc.Neurocybernetics, Inc.Neurodyne Medical Corp.Neuromechanical Innovations, LLCNeurotron Medical, Inc.Neurotronics, Inc.Neurovision Medical Products, Inc.Neurowave Systems, Inc.Neutraderm, Inc.New Leaf Medical, Inc.New Star Lasers, Inc.New Vistas, Inc.Newport Medical Instruments, Inc.Newton Laboratories, Inc.NexAir, LLCNexcore Technology, Inc.Nexcore Technology, Inc. Nexgen Pharma, Inc.Next Mobility, Inc.Niche Medical, Inc. Nomax, Inc.Non-Invasive Monitoring Systems, Inc.Norac, Inc.Noramco, Inc.Norman Noble, Inc.Northeast Resins & Silicones, LLCNostrum Laboratories, Inc.Nova Biomedical Corp.Nova Biomedical Corp. Diabetes ProductsNovamed USA, Inc.Novarad Corp.Novartis Consumer HealthNovartis Pharma Stein AGNovartis Pharmaceuticals Corp.NovartisPharma Schweizerhalle AGNovel Laboratories, Inc.Noven Pharmaceuticals, Inc.Novo Nordisk Pharmaceutical Industries, Inc.Novus Fine Chemicals, LLCNoxell Corp.Nsprire, Inc.Nu-World Corp.NuSil Technology, LLCNuaire, Inc.Nuclear Cardiology Systems, Inc.Nucletron Corp.Numia Medical Technology, LLCNustar, Inc.Nycomed US, Inc.OHM Pharma, Inc.OMT, LLCONC Solutions, Inc.ONCOlog Medical QA ABOakwood Laboratories, LLCObagi Medical ProductsOceanic Medical ProductsOcu-Ease Optical Products, Inc.Ocular Concepts, LLCOcular Instruments, Inc.Ohio Medical Corp.Ohio Valley Herbal Products, Inc.Ohm LaboratoriesOhm Laboratories, Inc.Omega & Delta Co., Inc.Omega Medical Imaging, Inc.Omega Packaging Corp.Omega Tech Labs, LLCOmega and Delta Co., Inc.Omni Surgical, L.P.Omnilife Science, Inc.Opthalmic Imaging SystemsOraLabs, Inc.Orchid Bio-Coat, LLCOrganics Corporation of America dba Ambix LaboratoriesOrigio MidAtlantic DevicesOrion Corp.Ormco Corp.OroScience, Inc.Ortheon MedicalOrtho Pharmaceutical Division of Janssen Ortho, LLCOrtho Pharmaceutical, Division of Janssen Ortho, LLCOrthoHelix Surgical Designs, Inc.Orthomerica Products, Inc.Orthopedic Designs North America, Inc.OsteoSymbionics, LLCOsteogenics Biomedical, Inc.Osteotech, Inc.Otovation, LLCOxygen Development, LLCOy Ajat Ltd.P-Ryton Corp.P.M.T. Corp.P4X, Inc.PCAS-Nanosyn, LLCPDS Manufacturing, Inc.PETNET Solutions Inc.PETNET Solutions, Inc.PSI Health SolutionsPT Products, LLCPace Tech, Inc.Pacira Pharmaceuticals, Inc.Pacira Pharmaceuticals, Inc. 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