Atlas FDA

2003

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

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RecordFirmDate
VIATORR ENDOPROSTHESIS (K024178)W. L. Gore & Associates, Inc.2003-03-07
TRUEZONE PEAK FLOW METER (K023097)Monaghan Medical Corp.2003-03-07
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM (K022167)Pall Corp.2003-03-07
URS-1B (BLOOD TEST) (K023297)Teco Diagnostics2003-03-06
INTERA FAMILY (K030520)Philips Medical Systems North America Co.2003-03-06
NEO 76 (K024141)Sb Lucius, Inc.2003-03-06
MODIFICATION TO SYNTHES CERVIFIX SYSTEM (K030377)Synthes (Usa)2003-03-06
KMEDIC EXTERNAL FIXATION DEVICES (K030336)Teleflex Medical Group2003-03-06
AIGIS-A (K024140)Sb Lucius, Inc.2003-03-06
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 (K022855)Bio-Medical Research, Ltd.2003-03-06
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES (K030483)Emerald Medical, Inc.2003-03-06
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM (K030372)Ebi, L.P.2003-03-06
REPICCI LOCKED KEEL TIBIAL BEARING (K030446)Biomet, Inc.2003-03-06
SURGICAL PATIENT WARMER, MODEL PW820 JHU (K022609)Fisher & Paykel Healthcare, Ltd.2003-03-06
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K024353)Trek Diagnostic Systems, Inc.2003-03-06
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM (K030373)Centerpulse Orthopedics, Inc.2003-03-06
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES (K030484)Emerald Medical, Inc.2003-03-06
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (K030462)Cobe Cardiovascular, Inc.2003-03-06
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) (K021533)Creative Contract (M) Sdn Bhd2003-03-05
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS (K021539)Creative Contract (M) Sdn Bhd2003-03-05
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING (K024065)Gish Biomedical, Inc.2003-03-05
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) (K030075)Best Manufacturing Company-Distribution Center2003-03-05
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR (K030449)Terumo Corp.2003-03-05
3.0T TORSO PHASED ARRAY COIL (K030495)Ge Medical Systems, Inc.2003-03-05
SMEARCLEAR (K024198)Sybron Dental Specialties, Inc.2003-03-05
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR (K022412)Fresenius Medical Care North America2003-03-05
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR (K021546)Creative Contract (M) Sdn Bhd2003-03-05
CIMOFLUOR (K023888)Global Dental Products, Inc.2003-03-05
IVD CRYPTO/GIARDIA DFA (K024113)Ivd Research, Inc.2003-03-05
VIDAR BONE TRACK SYSTEM SOFTWARE (K024171)Vidar Systems Corp.2003-03-04
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES (K022917)Home Care Technology Co., Ltd.2003-03-04
MIIG II BONE GRAFT SUBSTITUTE (K024336)Wrightmedicaltechnologyinc2003-03-04
SKINTACT ECG TAB ELECTRODE (K030509)Leonhard Lang GmbH2003-03-04
THE MULTILIFT (K024346)Services Industriels Savaria, Inc.2003-03-04
NUVASIVE MASH (K023319)Nuvasive, Inc.2003-03-04
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 (K030265)Zimmer, Inc.2003-03-04
SELF SEAL STERILIZATION POUCH (K023025)Granton Medical , Ltd.2003-03-04
IGLIDE MANUAL ASSIST WHEELCHAIR (K030250)Independence Technology, LLC2003-03-04
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS (K030344)Smith & Nephew, Inc.2003-03-04
ORIA CERVICAL PLATES (K023377)Ortho Tec, LLC2003-03-04
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K024015)Alliance Medical Corp.2003-03-04
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT (K023852)Services Industriels Savaria, Inc.2003-03-04
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A (K030408)Beckman Coulter, Inc.2003-03-04
ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A (K030105)Nihon Kohden America, Inc.2003-03-04
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS (K021878)Eska America Corp.2003-03-04
TENSCARE ULTIMA NMS/EMS (K023997)Tenscare, Ltd.2003-03-03
MS PAED-BABY BODY (K023796)Erich Jaeger GmbH2003-03-03
TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 (K030380)Tissuelink Medical, Inc.2003-03-03
BABYCARE (K023082)Bionet Company, Ltd.2003-03-03
TITANIUM OSSICULAR REPLACMENT SYSTEM (K030492)Invotec International, Inc.2003-03-03
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (K021537)Vermont Medical, Inc.2003-03-03
BAYER LIGAND PLUS 1, 2, 3 CONTROLS (K030452)Bayer Diagnostics Corp.2003-03-03
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE (K024338)General Gloves Corp.2003-03-03
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (K030163)Aseptico, Inc.2003-03-03
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED (K030335)Perusahaan Getah Asas Sdn. Bhd.2003-03-03
XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM (K024004)Friadent GmbH2003-03-03
CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN (K030524)Cd Leycom BV2003-03-03
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (K024182)Precision Systems, Inc.2003-03-03
PROMOTOR FINAL RINSE SPERM WASH MEDIUM (K024290)Ceres Fertility, Inc.2003-03-03
ASCENSIA BREEZE BLOOD GLUCOSE METER (K024062)Bayer Corp.2003-03-03
MIDMARK M9 ULTRACLAVE STEAM STERILIZER (K023348)Midmark Corp.2003-03-03
NYLON SUTURE (K024090)Aurolab2003-02-28
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K023455)Ciba Vision Corporation2003-02-28
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 (K023083)Mettler Electronics Corp.2003-02-28
SILK SUTURES (K024091)Aurolab2003-02-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (K030091)Bd Diagnostic Systems2003-02-28
CATHETER CONNECTOR (K023690)World Metals, Inc.2003-02-28
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE (K023985)Rockwell Medical Technologies, Inc.2003-02-28
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K022980)Given Imaging , Ltd.2003-02-27
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES (K030324)Radiant Innovation, Inc.2003-02-27
ALIBI BIOLOGICAL INDICATOR, MODEL WS (K024079)Arden Laboratories, Incorporated2003-02-27
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB (K030112)Pt. Smartglove Indonesia2003-02-27
AUTOMED 3200 INFUSION PUMP (K023973)Help Technologies2003-02-27
STARTOX DRUG OF ABUSE SCREENING TEST (4) (K022388)Starplex Scientific, Inc.2003-02-27
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET (K024050)Cook Urological, Inc.2003-02-27
DISPOSABLE BI-POLAR CABLE (K023966)Modern Medical Equipment Mfg., Ltd.2003-02-27
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM (K030315)Ultroid, LLC2003-02-27
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR (K030406)Pt. Smartglove Indonesia2003-02-27
TOP GLOVE VINYL EXAMINATION GLOVE (K024216)Top Glove (Zhangjiagang) Co. , Ltd.2003-02-27
0.55% ORTH-PHTHALALDEHYDE SOLUTION (K030004)Advanced Sterilization Products2003-02-27
HEM-O-LOK XL CLIP (K030311)Weck2003-02-26
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K030431)Ge Medical Systems Information Technologies2003-02-26
VERTE-SPAN SPINAL SYSTEM (K024049)Medtronic Sofamor Danek, Inc.2003-02-26
SCLERAL PLUGS, 19 AND 20 GAUGE (K022186)Microvision, Inc.2003-02-26
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (K030054)Fci Ophthalmics, Inc.2003-02-26
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023989)Contamac, Ltd.2003-02-26
CALCIGEN PSI BONE GRAFT SUBSTITUTE (K030178)Biomet, Inc.2003-02-26
INTERFERENTIAL STIMULATOR, MODEL RTM1000 (K030254)Ryan Telemedicine2003-02-26
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N (K030289)Integra Lifesciences Corp.2003-02-26
B.07 STAIRWAY CHAIRLIFT (K024345)Services Industriels Savaria, Inc.2003-02-26
STRYKER XCEL ANCHOR SYSTEM (K023013)Stryker Endoscopy2003-02-26
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR (K023917)Kawasumi Laboratories, Inc.2003-02-26
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (K030264)Jostra AG2003-02-26
MODIFICATION TO THE MAESTRO SYSTEM (K030463)BioHorizons Implant Systems, Inc.2003-02-26
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) (K023637)Tytan Medical Corp.2003-02-26
SMITH & NEPHEW FEMORAL HEADS (K024340)Smith & Nephew, Inc.2003-02-26
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER (K022214)Mechidyne Systems, Inc.2003-02-26
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (K030141)Cardiovention, Inc.2003-02-26
VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 (K030246)Victus, Inc.2003-02-26
PALABOND (K022251)Heraeus Kulzer GmbH & Co. KG2003-02-26
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Every clearance here is in the API, with alerts when new ones post.