Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K030552)Medtronic Surgical Navigation Technologies2003-03-19
HEMOSIL FACTOR XI DEFICIENT PLASMA (K030287)Instrumentation Laboratory CO2003-03-19
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (K030057)Spectral Diagnostics, Inc.2003-03-19
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES (K030005)Vanguard Medical Concepts, Inc.2003-03-18
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 (K023472)Class A Enterprises, Inc.2003-03-18
SIGHTFIX (K024251)World of Medicine Lemke GmbH2003-03-18
XYLOS SURGICAL MESH (K023237)Xylos Corporation2003-03-18
DUOMED, SERIES 500, (MODELS ID 500, FL 500) (K030140)Duomed, Inc.2003-03-18
DSG RELAXER SPLINT (K022627)Sentage Corporation D/B/A/ Dental Services Group2003-03-18
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES (K023954)Altus Medical, Inc.2003-03-18
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096)Bayer Diagnostics Corp.2003-03-18
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW (K030096)Arthrex, Inc.2003-03-18
SILVERLEAF CONTACT WOUND DRESSING (K013936)Silverleaf Technologies, Inc.2003-03-18
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 (K024305)Wiener Laboratories Saic2003-03-18
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 (K030626)Ortho-Clinical Diagnostics, Inc.2003-03-18
SUTURTEK FASTCLOSE SUTURING DEVICE (K030227)Suturtek Incorporated2003-03-17
ALTON PT STEPPER (K024183)Alton Design, LLC2003-03-17
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER (K024235)Dolphin Medical, Inc.2003-03-17
MODULEAF (K030609)Mrc Systems GmbH2003-03-17
SUPERBOND (K030161)American Dent-All, Inc.2003-03-17
FENESTRATED INFUSION CATHETER (K024190)Promedic, Inc.2003-03-17
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) (K024364)Synthes (Usa)2003-03-17
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K024357)Trek Diagnostic Systems, Inc.2003-03-17
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER (K023694)Biopsy Sciences, LLC2003-03-17
NEOSPORIN SCAR SOLUTION (K024160)Warner-Lambert Co.2003-03-17
BARD AQUAGUIDE URETERAL CONDUIT (K030438)C.R. Bard, Inc.2003-03-17
MODIFICATION TO CONTOUR POLARIS URETERAL STENT (K030503)Boston Scientific Corp2003-03-17
SAS RSV CONTROL KIT (K030628)Sa Scientific, Inc.2003-03-17
IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP (K024199)Osteobiologics, Inc.2003-03-14
GDC STRETCH RESISTANT DETACHABLE COIL (K030475)Boston Scientific, Target2003-03-14
MAS LIPID LEVEL 1 AND 2 (K030679)Medical Analysis Systems, Inc.2003-03-14
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES (K030228)Pt. Medisafe Technologies2003-03-14
GISH TUBING AND CONNECTORS WITH GBS COATING (K030077)Gish Biomedical, Inc.2003-03-14
GEM, MODEL 004110 (K030464)Collins Medical, Inc.2003-03-14
SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (K024124)Chf Solutions, Inc.2003-03-14
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER (K024275)United States Surgical, A Division of Tyco Healthc2003-03-14
CPCA2000 COUNTERPULSATION SYSTEM (K030532)Cpca2000, Inc.2003-03-14
ORAMAGICRX ORAL WOUND RINSE (K024180)Mpm Medical., Inc.2003-03-14
GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET (K030467)Iv Medical, Inc.2003-03-14
EXPRESS MINI GLAUCOMA SHUNT (K030350)Optonol, Ltd.2003-03-13
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM (K030455)Philips Ultrasound, Inc.2003-03-13
MICROFIX QUICKANCHOR PLUS (K024115)Mitek Worldwide2003-03-13
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS (K030566)Cliniqa Corporation2003-03-13
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (K023105)Elan Diagnostics2003-03-13
GYRUS PLASMA SKIN RESURFACING SYSTEM (K023111)Gyrus Medical, Inc.2003-03-13
CANDELA GENTLE YAG LASER SYSTEM (K022923)Candela Corp.2003-03-13
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K024335)Candela Corp.2003-03-12
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 (K023693)Airex, Inc.2003-03-12
KAVO EVEREST TITANBLANK (K024214)Kavo America2003-03-12
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT (K030036)Pulpdent Corporation2003-03-12
MSI TA ELECTRODES (K024266)Medsphere International, Inc.2003-03-12
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR (K030038)Philips Medical Systems, Inc.2003-03-12
NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (K024201)Image-Guided Neurologics, Inc.2003-03-12
GAMMAMED 212 AND 232 SOURCE ASSEMBLY (K030745)Varian Medical Systems2003-03-12
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE (K024138)Olympus Optical Co., Ltd.2003-03-12
OPTIMA, SPINAL SYSTEM (K024096)U&I Corp., America2003-03-12
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 (K022004)Biosensors International-USA2003-03-12
MODIFICATION TO VNUS CLOSURE SYSTEM (K030557)Vnus Medical Technologies, Inc.2003-03-11
CCD CAMERA, MODEL PKP-06000-000 (K024085)Perkins Electronics Co.2003-03-11
VICTOREEN THEBES II, MODEL 7020 (K024284)Syncor Radiation Management2003-03-11
OPTIDOS (K010705)Ptw-New York Corp.2003-03-11
REPROCESSED COMPRESSION SLEEVES (K024087)Alliance Medical Corp.2003-03-11
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 (K030476)Concentric Medical, Inc.2003-03-11
OSSE-LIGN (K023564)Osseus, LLC2003-03-11
ENDOS AC/ACP (K030185)Villa Sistemi Medicali S.P.A.2003-03-11
IMBIBE BONE MARROW ASPIRATION SYRINGE (K023074)Orthovita, Inc.2003-03-11
RAPID PROGRAMMAR (K030118)Advanced Neuromodulation Systems2003-03-11
VACUFLASH BIOPSY SYSTEM (K024089)Bip USA, Inc.2003-03-11
TRACERS BONE CEMENT OPACIFIER (K023445)Parallax Medical, Inc.2003-03-11
C.T.M. MOBILITY SCOOTER, MODEL HS-890 (K030387)C.T.M. Homecare Product, Inc.2003-03-11
FYRELINK (K030242)Mpacs, LLC2003-03-10
RMO PLASMA CURING LIGHT (K024374)Lokki Lasers Medicaux2003-03-10
AIGIS-SOFT (K024136)Sb Lucius, Inc.2003-03-10
KENDRO HERACELL 240 INCUBATOR (K023465)Kendro Laboratory Products, L.P.2003-03-10
AIGIS-FINE (K024143)Sb Lucius, Inc.2003-03-10
ATAC PAK MAGNESIUM REAGENT (K030010)Elan Diagnostics2003-03-10
IRRIGATION SETS (K023808)International Medsurg Connection2003-03-10
AIGIS-PLUS (K024135)Sb Lucius, Inc.2003-03-10
AMERICAN CATHETER, MODEL W3 (K030538)Catheter, LLC2003-03-10
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM (K030420)GE Medical Systems2003-03-10
DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR (K024077)Zewa, Inc.2003-03-10
LIFESTENT BILIARY ENDOPROSTHESIS (K023121)Orbus Medical Technologies2003-03-10
AIGIS-SUPER (K024142)Sb Lucius, Inc.2003-03-10
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM (K030409)Cordis Corp.2003-03-10
STRYKERWARE SYSTEM (K024159)Stryker Endoscopy2003-03-10
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN (K030164)Yty Industry (Manjung) Sdn Bhd2003-03-07
XYLOS XCELL ANTIMICROBIAL DRESSING (K024054)Xylos Corporation2003-03-07
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
AIGIS-XO (K024145)Sb Lucius, Inc.2003-03-07
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS (K030551)Arthrocare Corp.2003-03-07
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX (K030460)Brennen Medical, Inc.2003-03-07
CAUTERY TIP CLEANER, MODEL-TC-100 (K030339)Aspen Surgical Products, Inc.2003-03-07
AIGIS-INLAY (K024139)Sb Lucius, Inc.2003-03-07
REPROCESSED COMPRESSION SLEEVES (K024074)Alliance Medical Corp.2003-03-07
AIGIS-PT (K024144)Sb Lucius, Inc.2003-03-07
ATAC PAK ALBUMIN REAGENT (K030006)Elan Diagnostics2003-03-07
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 (K024061)Peregrine Surgical , Ltd.2003-03-07
NAUTICA MICRO CATHETER, MODEL 105-5094-153 (K024122)Micro Therapeutics, Inc.2003-03-07
AUDIOSCREENER OAE+ABR (K024205)Everest Biomedical Instruments Co.2003-03-07
IM2001 PULSE OXIMETER (K012706)Imagyn Medical Technologies, Inc.2003-03-07
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Every clearance here is in the API, with alerts when new ones post.