Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) (K991324)Heinz Kurz1999-05-18
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT (K984022)Arrow Intl., Inc.1999-05-18
FLEXIBLE VASCULAR CLAMP, VERSION 2 (K991589)Allegiance Healthcare Corp.1999-05-18
LAMINOSS DENTAL IMPLANT (K982925)Impladent , Ltd.1999-05-18
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 (K990509)Implemed, Inc.1999-05-18
CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES (K990586)Conmedcorp1999-05-17
CVS PERSONAL LUBRICANT (K983216)San-Mar Laboratories, Inc.1999-05-17
IONOSIT BOND (K991172)Dmg Chemisch Pharmazeutische Fabrik GmbH1999-05-17
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (K990669)Dongkuk Techco Rubber Industries Sdn. Bhd.1999-05-17
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER (K990585)Idem (Int'L Dist. of Electronics For Medicine)1999-05-17
ORTHO-GLOW GLITTER (K990699)Harry J. Bosworth Co.1999-05-17
MANOMETRIC ASSEMBLIES (K983665)Dentsleeve Pty., Ltd.1999-05-17
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- (K983720)Asahi Medical Co., Ltd.1999-05-17
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT (K991461)Howmedica Osteonics Corp.1999-05-17
JACKSON ESOPHAGEAL DILATOR (K990935)Pilling Weck Surgical1999-05-17
GALLINI BYCUT NEEDLE (K990716)Gallini U.S., LLC1999-05-17
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER (K990652)Idem (Int'L Dist. of Electronics For Medicine)1999-05-17
SYNERGY IOM SYSTEM (K984052)Oxford Instruments Medical Systems1999-05-17
ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES (K990474)Oratec Interventions, Inc.1999-05-17
PRE POWDERED LATEX EXAMINATION GLOVES (K990879)Apl Products Sdn. Bhd.1999-05-17
NUGARD NITRIL NITRILE EXAMINATION GLOVE (K990841)Terang Nusa Sdn Bhd1999-05-17
TOTALBOND (K990381)Parkell, Inc.1999-05-17
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES (K991030)Ethicon Endo-Surgery, Inc.1999-05-17
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION (K990848)Immedica, Inc.1999-05-17
LATEX EXAMINATION GLOVES (POWDERED) (K984229)Sama Kejuruteraan Sdn.Bhd.1999-05-17
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 (K991627)Respironics, Inc.1999-05-17
BQ/BM INTEGRATED LASER DELIVERY SYSTEM (K990665)American Laser Corp.1999-05-17
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE (K990840)Terang Nusa Sdn Bhd1999-05-17
COPALIS EBV-M ANTIBODY ASSAY (K991459)DiaSorin, Inc.1999-05-14
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K983715)Bayer Corp.1999-05-14
KERATOME SYSTEM, MODEL K3000 (K984537)Insight Technologies Instruments, LLC1999-05-14
K-ASSAY CRP (K991224)Kamiya Biomedical Co.1999-05-14
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS (K991550)Wesley Jessen Corp.1999-05-14
CONSEAL F (K990650)Southern Dental Industries, Inc.1999-05-14
PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) (K991404)Itl Corporation Pty, Ltd.1999-05-14
BONE MULCH SCREW SYSTEM (K991298)Biomet, Inc.1999-05-14
EXCELART (K990620)Toshiba America Mri, Inc.1999-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK (K983875)Ortho-Clinical Diagnostics, Inc.1999-05-14
TAS ANALYZER, MODEL 1009 (K990566)Cardiovascular Diagnostics, Inc.1999-05-14
OPTICAL FORCEPS (K990561)Pilling Weck Surgical1999-05-14
FLEXNEEDLE PLUS (K990693)Act Medical, Inc.1999-05-14
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 (K991048)Pharmacia & Upjohn Co.1999-05-14
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 (K990568)Synergetics, Inc.1999-05-14
NOVUS VERDI DELIVERY SYSTEMS (K991258)Lumenis, Inc.1999-05-13
UROMED BRACHYTHERAPHY IODINE-125 SOURCES (K982226)Uromed Corp.1999-05-13
LORENZ IMF SCREW (K983728)Walter Lorenz Surgical, Inc.1999-05-13
PULSEMASTER DENTAL LASER SYSTEM (K984486)American Dental Technologies, Inc.1999-05-13
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX (K983575)Datascope Corp.1999-05-13
ITI DENTAL IMPLANT SYSTEM (K984104)Straumann USA1999-05-13
IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 (K991094)Diagnostic Products Corp.1999-05-13
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE (K990698)Omnigrace (Thailand) , Ltd.1999-05-13
IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 (K991096)Diagnostic Products Corp.1999-05-13
3M CLINPRO PROPHY PASTE, MODEL 12611 (K990482)Minnesota Mining and Mfg. Co.1999-05-13
HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR (K990479)Hygenitek, Inc.1999-05-13
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM (K990515)International Medical Systems1999-05-13
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE (K990696)Omnigrace (Thailand) , Ltd.1999-05-13
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES (K990729)Acc Intl.1999-05-13
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 (K991484)Allegiance Healthcare Corp.1999-05-13
ACCLAIM INFUSION PUMP (K991501)Abbott Laboratories1999-05-13
PHILIPS TOMOSCAN AV-NT (K991278)Philips Medical Systems North America, Inc.1999-05-13
DMD DIGITAL X-RAY SYSTEM (K990087)Dental/Medical Diagnostic Systems, Inc.1999-05-13
HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL (K991129)Hitachi Medical Corp. of America1999-05-13
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU (K991363)Sorenson Medical, Inc.1999-05-13
1000 PRESSURE INFUSION SIGMACON 1000 (K990447)Valley West, Inc.1999-05-12
ROCS ULTRASEED (K984241)Radiation Oncology Computer Systems1999-05-12
CALCIUM SCORING (K990426)Siemens Medical Solutions USA, Inc.1999-05-12
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION (K990455)Philips Medical Systems, Inc.1999-05-12
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (K990441)Sandhill Scientific, Inc.1999-05-12
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM (K990550)Ge Medical Systems, Inc.1999-05-11
K-ASSAY CRP CALIBRATOR SET (K991210)Kamiya Biomedical Co.1999-05-11
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW (K990093)Agilent Technologies1999-05-11
TRACER O-T-W MAPPING DEVICE (K972803)Cardima, Inc.1999-05-11
ABBOTT ARCHITECT CEA (K990774)Abbott Laboratories1999-05-11
COULTER Z2 ANALYZER (K991070)Coulter Corp.1999-05-11
AIA-PACK FT3 ASSAY (K991252)Tosoh Medics, Inc.1999-05-11
DBEST OCCULT BLOOD TEST KIT (K984269)Ameritek, Inc.1999-05-11
CALCITONIN (K990073)Kmi Diagnostics, Inc.1999-05-11
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM (K991136)Olympus America, Inc.1999-05-11
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K (K990957)Astoria-Pacific, Inc.1999-05-11
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 (K990442)Vital Images, Inc.1999-05-11
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K990011)Continental Soft Lens, Inc.1999-05-11
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE (K990411)Karl Storz Endoscopy1999-05-11
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480)Alcon Laboratories1999-05-10
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE (K990671)Hurricane Medical1999-05-10
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS (K984098)Adventures IN Color Technology, Ltd.1999-05-10
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY (K991369)Germaine Laboratories, Inc.1999-05-10
SAS ONE-STEP PREGNANCY (K990741)Sa Scientific, Inc.1999-05-10
ATLAST GLUCOSE CONTROL SOLUTION (K991075)Amira Medical, Inc.1999-05-10
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983408)Dade Microscan, Inc.1999-05-10
MODIFICATION OF SAS SERUM/URINE HCG (K990684)Sa Scientific, Inc.1999-05-10
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF (K983039)Schneider/Namic1999-05-07
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) (K990678)Salter Labs1999-05-07
TTCGHI-T AND TTCTN3-T-T (K982451)Tinnitus Treatment Centers, Inc.1999-05-07
FLOW LINE (K990756)Heraeus Kulzer, Inc.1999-05-07
STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION (K991436)Sterngold1999-05-07
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER (K990507)Althin Biopharm, Inc.1999-05-07
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991134)Vistakon, Johnson & Johnson Vision Products, Inc.1999-05-06
FALCON IVF ONE WELL DISH (K991251)Becton Dickinson Labware1999-05-05
FALCON IVF FOUR WELL PLATE (K991249)Becton Dickinson Labware1999-05-05
APOLLO 5, APOLLO 10 (K990383)Precitron A.B.1999-05-05
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Every clearance here is in the API, with alerts when new ones post.