Atlas FDA

2003

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

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RecordFirmDate
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (K030383)Depuyacromed2003-02-26
V.A.C. ABDOMINAL DRESSING (K022011)Kinetic Concepts, Inc.2003-02-26
SENORX ES-300 (K030473)Senorx, Inc.2003-02-26
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023987)Contamac, Ltd.2003-02-26
ZEPHIR ANTERIOR CERVICAL SYSTEM (K030327)Medtronic Sofamor Danek2003-02-26
U2 ACETABULAR CUP (K022520)United Orthopedic Corp.2003-02-25
JAX (K010555)Smith & Nephew, Inc.2003-02-25
MICROSURGICAL BIPOLAR HANDPIECE (K024304)Neomedix Corp.2003-02-25
UNICONDYLAR FEMORAL COMPONENT (K030301)Smith & Nephew, Inc.2003-02-25
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (K023949)Image-Guided Neurologics, Inc.2003-02-25
MODIFICATION TO TSRH SPINAL SYSTEM (K030285)Medtronic Sofamor Danek, Inc.2003-02-25
FIRST RESPONSE PREGNANCY TEST (K030258)Armkel, LLC2003-02-25
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND (K024100)Theratech, Inc.2003-02-25
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX (K030299)Oriental System Technology, Inc.2003-02-25
WAKO L-TYPE GLUCOSE 2 (K024281)Wako Chemicals USA, Inc.2003-02-24
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 (K030182)Bio-Rad2003-02-24
MEDCOMP SC4 (K022678)Medcomp2003-02-24
PREMIER III PHASED ARRAY CTL SPINE COIL (K030042)Usa Instruments, Inc.2003-02-24
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR (K024210)Beckman Coulter, Inc.2003-02-24
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A (K023931)Philips Medical Systems, Inc.2003-02-24
OXYBOX SYSTEM (K023456)Oxyfast Corporation2003-02-24
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 (K023942)Yamato Corp.2003-02-24
BIORAPID MONONUCLEOSIS (K030215)Instrumentation Laboratory CO2003-02-24
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 (K030253)Ortho Tec, LLC2003-02-21
COAXIA FLOCONTROL CATHETER (K023914)Coaxia, Inc.2003-02-21
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES (K030190)Suzhou Sen Sen Medical Supplies , Ltd.2003-02-21
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 (K024309)Advanced Respiratory2003-02-21
LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL (K023982)Usa Instruments, Inc.2003-02-21
AUTOCON II 200 ELECTROSURGICAL GENERATOR (K023924)Karl Storz Endoscopy2003-02-21
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (K030045)Olympus America, Inc.2003-02-21
TERUMO SURGUARD SAFETY SYRINGE (K024249)Terumo Medical Corp.2003-02-21
PMH 1000 HEATED HUMIDIFIER (K013856)Pegasus Research Corp.2003-02-21
SABER TECH IMPLANTS SYSTEM (K024044)Imtec Corp.2003-02-21
SYNTRA + DIALYZER, MODEL 200 (K023664)Baxter Healthcare Corp2003-02-21
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) (K030252)Ortho Tec, LLC2003-02-21
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K030240)Computer Motion, Inc.2003-02-21
PRIMELUNG (K024149)Accuimage Diagnostics Corp.2003-02-21
JASUN, MODELS DT-01F AND DT-11F (K030361)Hangzhou Hua'An Medical & Health Instruments Co.,2003-02-21
JEROME GLASS RING (K023959)The Jerome Group, Inc.2003-02-21
MERIT MEDICAL 1-ML SYRINGE (K024052)Merit Medical Systems, Inc.2003-02-21
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL (K030286)Biosite Incorporated2003-02-21
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS (K024193)Ortho-Clinical Diagnostics2003-02-21
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (K021945)Planmed OY2003-02-21
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM (K030241)Blackstone Medical, Inc.2003-02-21
MACROPORE SURGICAL BARRIER FILM (K023643)Macropore Biosurgery, Inc.2003-02-21
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K023929)Advanced Imaging Research, Inc.2003-02-21
GELBFISH FLEX VASCULAR DILATOR (K030260)Vascumetrix, LLC2003-02-20
MEDLITE Q-SWITHCED LASER (K022709)Continuum Electro-Optics, Inc.2003-02-20
ADVANCE LESS CONFORMING TIBIAL COMPONENT (K030193)Wrightmedicaltechnologyinc2003-02-20
SMALL BARD VENTRALEX PATCH (K024008)C.R. Bard, Inc.2003-02-20
MAGIC INFUSION CATHETER (K023351)Advanced Interventional Technologies, LLC2003-02-20
DUAL YELLOW LASER, MODEL D10B (K023899)Norseld Pty., Ltd.2003-02-20
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595)Xenotope Diagnostics, Inc.2003-02-20
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT (K030236)Exactech, Inc.2003-02-20
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE (K023903)Wilson-Cook Medical, Inc.2003-02-20
CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ (K030266)Berkeley Advanced Biomaterials, Inc.2003-02-20
LUNEAU STERILE TONOMETER SEPARATION PRISMS (K023838)Luneau SA2003-02-20
ACCOUSONIC PLUS, MODEL AP-170 (K030410)Metron Medical Australia, Pty, Ltd.2003-02-20
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 (K023630)Guidant Corporation, Cardiac Surgery2003-02-20
DYONICS POWER CONTROL UNIT (K030196)Smith & Nephew, Inc.2003-02-20
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (K024162)Helena Laboratories2003-02-19
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER (K030354)Bisco, Inc.2003-02-19
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K030148)Shanghai Palomar Mountain Industries, Inc.2003-02-19
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 (K030137)Avail Medical Products, Inc.2003-02-19
ENDO-GLIDE GUIDEWIRE (K023603)Endo-Therapeutics, Inc.2003-02-19
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM (K023906)The Prometheus Group2003-02-19
CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT (K023463)Cryo Vascular Systems, Inc.2003-02-19
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) (K022814)Pt. Smartglove Indonesia2003-02-19
PRECISION CAPILLARIES FOR MICROMANIPULATION (K024302)Brinkmann Instruments, Inc.2003-02-19
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (K030157)Wrp Asia Pacific Sdn. Bhd.2003-02-19
THE BREATHE EZ ANTI-SNORING DEVICE (K022891)D&S Redhage2003-02-19
MCPULSE (K023238)Meridian Co., Ltd.2003-02-19
NEXUS INJECTION SITE (NIS), MODEL NIS-1 (K024363)Nexus Medical, LLC2003-02-19
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM (K023882)Implex Corp.2003-02-19
TRAVELAIR PORTABLE COMPRESSION SYSTEM (K022340)Dynamic Air, Inc.2003-02-19
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES (K023787)Lhasa Medical, Inc.2003-02-14
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE (K023843)Opus Medical, Inc.2003-02-14
4 SEASONS (K024094)Ivoclar Vivadent, Inc.2003-02-14
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (K023407)Elan Diagnostics2003-02-14
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K024045)Contamac, Ltd.2003-02-14
SAMARITAN AED, MODEL SAM-01 (K023854)Heartsine Technologies, Inc.2003-02-14
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI (K023050)Reliant Technologies, Inc.2003-02-14
SURGICAL TITANIUM MESH SYSTEM (K030249)Depuyacromed2003-02-14
STEERABLE GUIDEWIRE (K022813)Lake Region Mfg., Inc.2003-02-14
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K024071)Guidant Corporation, Cardiac Surgery2003-02-14
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: (K023848)Igc-Medical Advances, Inc.2003-02-14
ALBUMIN COBALT BINDING TEST (ACB TEST) (K023824)Ischemia Technologies, Inc.2003-02-14
PLATELETWORKS, MODELS PW-A, PW-C (K023761)Helena Laboratories2003-02-14
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 (K022071)Embol-X, Inc.2003-02-14
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE (K023953)St. George Technology, Inc.2003-02-14
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 (K024097)Summit Medical , Ltd.2003-02-14
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR (K023072)Arista Latindo Industrial Ltd. P.T2003-02-13
SMARTSET HV BONE CEMENT (K023012)DePuy Orthopaedics, Inc.2003-02-13
6203 (K022865)Contemporary Products, Inc.2003-02-13
DAVOL ARTHROVENT OUTFLOW TUBING (K030307)Davol, Inc.2003-02-13
N LATEX IGA (K024038)Dade Behring, Inc.2003-02-13
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES (K023974)Top Glove Sdn. Bhd.2003-02-13
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 (K021588)Biomedical Life Systems, Inc.2003-02-13
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX (K022815)Pt. Smartglove Indonesia2003-02-13
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 (K021580)LeMaitre Vascular, Inc.2003-02-12
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Every clearance here is in the API, with alerts when new ones post.