Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (K021019)Genzyme Corp.2002-06-18
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM (K021009)Spinal Concepts, Inc.2002-06-18
300 PV COMPLETE ELECTROTHERAPY SYSTEM (K021100)Empi2002-06-18
NAKAO SNARE II AND NAKAO SNARE III (K020891)Granit Medical Innovations2002-06-17
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST (K021423)Alfa Scientific Designs, Inc.2002-06-17
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN (K021181)Dade Microscan, Inc.2002-06-17
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081)The Binding Site, Ltd.2002-06-17
CARDIOSPECT D90/CARDIO CAM (K021823)Nuclear Cardiology Systems, Inc.2002-06-17
AMX-4 PLUS MOBILE X-RAY SYSTEM (K021016)GE Medical Systems2002-06-17
BLOOD-PRESSURE METER (K021252)Idt Technology Limited2002-06-17
AIRCAST, MODEL #3011 (K013297)Millenium Reprocessing Services, Inc.2002-06-14
SECURE RELINE/PICKUP MATERIAL (K021586)Imtec Corp.2002-06-14
HEMOGLOBIN A1C CONTROL (K021484)Canterbury Scientific , Ltd.2002-06-14
RADIUS SNARE (K021441)Radius Medical Technologies, Inc.2002-06-14
ENDOMAP (K014113)Siemens Medical Solutions USA, Inc.2002-06-14
SOPRO LIGHT SOURCES AND ACCESSORIES (K020915)Sopro2002-06-14
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE (K020896)Osypka Medical, Inc.2002-06-14
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES (K020907)Medicotest A/S2002-06-14
MEDGEM (K021605)Healthetech, Inc.2002-06-14
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER (K020857)Vasomedical, Inc.2002-06-14
KARMA 800 SERIES MANUAL WHEELCHAIR (K021866)Vestil Manufacturing Corp.2002-06-14
ECHO-SCREEN T, TA, TD, TDA, TC (K013977)Fischer-Zoth Audiologic Systems, Inc.2002-06-14
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C (K021632)Uresil, L.P.2002-06-13
X-IMAGE DIGITAL X-RAY SYSTEM (K020588)Escape Technology, Inc.2002-06-13
HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 (K021656)Nuclear Diagnostics2002-06-13
EBV V VCA IGM ELISA KIT MODEL# EBM-200 (K020717)Pan Bio Pty. , Ltd.2002-06-13
SPATOUCH PHOTOEPILATION SYSTEM (K020856)Radiancy (Israel) , Ltd.2002-06-13
NUVASIVE MESH (K020853)Nuvasive, Inc.2002-06-13
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (K013022)Sulzer Carbomedics, Inc.2002-06-13
RPI REPLACEMENT HEATING ELEMENTS (K020966)Replacement Parts Industries, Inc.2002-06-13
EBV-VCA IGG ELISA TEST, MODEL EBG-100 (K020706)Pan Bio Pty. , Ltd.2002-06-13
EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (K020707)Pan Bio Pty. , Ltd.2002-06-13
DEROYAL SURGICAL, UMBILICUP (K020753)Deroyal2002-06-13
ORACAM (K020957)Video Dental Concepts, Inc.2002-06-13
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (K020603)Good Biotech Corp.2002-06-13
RS2MI MUSCLE STIMULATOR FAMILY (K021763)Rs Medical2002-06-13
MODIFICATION TO ENVOY AND VISTA BRITE TIP (K021593)Cordis Corp.2002-06-13
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER (K020630)Ultrasonix Medical Corporation2002-06-13
SYNGO MR 2002B (K020991)Siemens Medical Solutions USA, Inc.2002-06-13
MAMMOPATH (K021113)Fischer Imaging Corp.2002-06-13
MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL (K021433)Medical Advances, Inc.2002-06-13
PRECISET DAT PLUS (K021393)Quantimetrix Corp.2002-06-13
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 (K020835)Biolitec, Inc.2002-06-12
DOUBLE SPRINGERS NONOXNOL 9 CONDOM (K012969)Medtech Products , Ltd.2002-06-12
ESOP CO-CR FEMORAL HEADS (K021109)Fournitures Hospitalieres2002-06-12
DERMMATRIX SURGICAL MESH (K021160)Carbon Medical Technologies, Inc.2002-06-12
APEX MEDICAL DIGITAL TENS TS1211, TS1212 (K021755)Apex Medical Corp.2002-06-12
EXCELLITE LIGHT CURE UNIT (K020884)Rolence Ent., Inc.2002-06-12
OBC-127 BREAST ARRAY COIL (K021575)Mri Devices Corp.2002-06-12
HNC-127-TRIO NEUROVASCULAR ARRAY COIL (K021570)Mri Devices Corp.2002-06-12
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) (K012701)Accumetrics, Inc.2002-06-12
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL (K021715)Exactech, Inc.2002-06-12
ACUSTIM (K014273)S.H.P. Intl. Pty., Ltd.2002-06-12
BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I (K020834)Becton Dickinson Infusion Therapy Systems, Inc.2002-06-12
ULTRA-LITE 5 TURBO LIGHT CURE UNIT (K020874)Rolence Ent., Inc.2002-06-12
SYNTHES 3.5 MM BROAD LC-DCP PLATES (K020872)Synthes (Usa)2002-06-12
K-Y BRAND ULTRA GEL PERSONAL LUBRICANT (K020827)Personal Products Co., Div. of Mcneil Ppc, Inc.2002-06-12
AFB (ABSORBABLE FOAM BUTTRESS) (K014183)J&J Corporate Biomaterials Center2002-06-12
EXCELLITE TURBO LIGHT CURE UNIT (K020877)Rolence Ent., Inc.2002-06-12
CALCIGEN-S BONE VOID FILER (K013790)Biomet Orthopedics, Inc.2002-06-11
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) (K020869)Worldwide Medical Corp.2002-06-11
ACCU-CHEK ADVANTAGE MODULE (K021513)Roche Diagnostics Corp.2002-06-11
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K021667)Safehealth Medical Supply Corp.2002-06-11
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O (K021561)Wrp Specialty Products Sdn. Bhd.2002-06-11
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL (K021018)Dade Microscan, Inc.2002-06-11
BIOSCREW XTRALOK (K013131)Linvatec Corp.2002-06-11
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM (K020866)Abbott Diabetes Care, Inc.2002-06-11
OXYARM CO2 (K014211)Southmedic, Inc.2002-06-11
PLEXOLONG SETS (K013041)Pajunk GmbH2002-06-11
TOTAL HIP FEMORAL HEAD - 12/14 TAPER (K021673)Smith & Nephew, Inc.2002-06-11
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM (K012512)Radiant Medical2002-06-11
RABEA CEMENT RESTRICTOR (K020836)Signus Medical, LLC2002-06-11
COULTER CELLPREP (K021150)Beckman Coulter, Inc.2002-06-11
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) (K020410)Dade Behring, Inc.2002-06-11
TERUMO GAS FILTER (K021020)Terumo Cardiovascular Systems Corp.2002-06-10
STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K020297)Nova Biomedical Corp.2002-06-10
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 (K021381)Dade Behring, Inc.2002-06-10
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC (K014067)Princeton BioMeditech Corp.2002-06-10
SURGISIS GUIDED TISSUE REGENERATION MATRIX (K010952)Cook Biotech, Inc.2002-06-10
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC (K014066)Princeton BioMeditech Corp.2002-06-10
OPTAX SYSTEM (K020800)Optax Systems, Inc.2002-06-10
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS (K021850)Synthes (Usa)2002-06-10
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC (K014069)Princeton BioMeditech Corp.2002-06-10
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM (K021833)Blue Sky Bio2002-06-10
MARKNEW PRODUCTS ACUPUNCTURE NEEDLES (K020880)Marknew Products2002-06-10
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM (K021388)Seal Polymer Industries Bhd.2002-06-10
CEFAR MEDICAL AB CEFAR PRIMO (K020803)Cefar Medical AB2002-06-10
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE (K021598)Eci Medical Technologies, Inc.2002-06-10
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR (K021536)Wrp Specialty Products Sdn. Bhd.2002-06-10
STARTOX DRUG OF ABUSE SCREENING TEST (K021006)Starplex Scientific, Inc.2002-06-10
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (K021743)Copioumed Intl., Inc.2002-06-10
PORTABLE HDX INTRAORAL X-RAY (K021378)Dentalez Group2002-06-07
CLEARFIL SA PRIMER (K021427)Kuraray Medical, Inc.2002-06-07
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED (K021412)Arista Latindo Industrial Ltd. P.T2002-06-07
VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (K021372)J. Morita USA, Inc.2002-06-07
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB (K020783)Telesis Technologies, Inc.2002-06-07
INSIGHT, MODEL S980000 (K012232)Sandhill Scientific, Inc.2002-06-07
DUPLOREACH (K014088)Baxter Healthcare Corp2002-06-07
SECTRA OSTEOPOROSIS PACKAGE (K021527)Sectra-Imtec AB2002-06-07
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES (K013980)Safe Shield Co., Ltd.2002-06-06
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