Atlas FDA

2002

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

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RecordFirmDate
PULPDENT SEMI-GEL ETCH (K022492)Pulpdent Corporation2002-10-11
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT (K022620)Spire Biomedical, Inc.2002-10-11
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM (K023130)Mri Devices Corp.2002-10-11
COMFORT WINDJOY SCOOTER, MODEL LY-EW302 (K022369)Comfort Orthopedic Co., Ltd.2002-10-11
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS (K023100)General Electric Medical Systems Information Techn2002-10-11
VINYL EXAMINATION GLOVES, PRE-POWDERED (K023145)Shandong Jiazhan Plastic Products Co., Ltd.2002-10-11
COBRASCAN CR-1 FILMLESS (K022810)Radiographic Digital Imaging, Inc.2002-10-11
KOWA AUTOMATED TONOMETER KT-500 (K013805)Kowa Optimed, Inc.2002-10-11
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL (K020839)Lumenis, Inc.2002-10-11
VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION (K022562)Nobel Biocare AB2002-10-11
AUDIOTRAVELLER, MODEL AA222 (K022728)Interacoustics A/S, Assens2002-10-11
KIMAX QMA (K022585)Medical Metrics, Inc.2002-10-11
SMARTPACS (K022710)Taiwan Electronic Data Processing Corporation2002-10-11
TGDC-01 PRA (K021937)Truevision Instruments2002-10-11
STOCKERT CORONARY PERFUSION CANNULAE (K022280)Stockert Instrumente GmbH2002-10-11
HITACHI ALTAIRE (K022390)Hitachi Medical Systems America, Inc.2002-10-11
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD (K022336)Tangshan Zhonghong Pulin Group Co., Ltd.2002-10-11
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K022897)Computer Motion, Inc.2002-10-11
SPIFE CK KIT, MODEL 3332, 3333 (K022757)Helena Laboratories2002-10-11
BBC-63-GE BREAST ARRAY COIL (K023164)Mri Devices Corp.2002-10-11
CONTACT LASER & DIAGNOSTIC LENSES (K023221)Volk Optical, Inc.2002-10-11
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (K022716)Med-Logics, Inc.2002-10-11
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL (K021752)Lucid Korea Co., Ltd.2002-10-11
10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL (K020936)Medcomp2002-10-11
NITRILE POWDER-FREE EXAMINATION GLOVES (K022765)Allegiance Healthcare Corp.2002-10-11
ACUITY RADIATION THERAPY SIMULATOR (K023052)Varian Medical Systems, Inc.2002-10-11
HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE (K021087)Erecords Limited2002-10-11
REUSABLE BRONCHIAL BIOPSY FORCEPS (K022398)Ballard Medical Products2002-10-11
EMS 400 (K022493)Body Clock Health Care, Ltd.2002-10-11
AART SILICONE TUBING (K022306)Aesthetic and Reconstructive Technologies, Inc.2002-10-10
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K022316)Vanguard Medical Concepts, Inc.2002-10-10
TWINKY STAR (K022797)Voco GmbH2002-10-10
CLEAR-IT ANTI-FOG, MODEL PS003 (K022826)Preservation Solutions, Inc.2002-10-09
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238)Medtronic Vascular2002-10-09
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) (K022472)Nichols Institute Diagnostics2002-10-09
EZ-SCOPE AN, EZ-SCOPE LIGHT (K022342)Anzai Medical Co., Ltd.2002-10-09
MODIFICATION TO FOCUS (K022630)Instrumentarium Corp.2002-10-09
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) (K023207)Toshiba America Medical Systems, In.C2002-10-09
REPROCESSED DISPOSABLE TROCARS (K022743)Medical Device Services2002-10-09
BOSWORTH CORACO-CLAVICULAR SCREW (K023294)Howmedica Osteonics Corp.2002-10-09
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA (K023285)Axis-Shield Diagnostics, Ltd.2002-10-09
NITRILE POWDER-FREE EXAMINATION GLOVES (K023170)Allegiance Healthcare Corp.2002-10-09
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM (K023102)Howmedica Osteonics Corp.2002-10-09
W-5 (K022811)Ivoclar Vivadent, Inc.2002-10-09
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM (K022580)Becton, Dickinson & CO2002-10-09
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS (K022748)Medical Device Services2002-10-09
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (K022785)Axon Systems, Inc.2002-10-09
FRYE ADJUSTING INSTRUMENT (K021238)Frye Health Systems2002-10-09
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 (K022489)Summit Medical , Ltd.2002-10-09
JET-X TIN COATED HALF PINS (K023134)Smith & Nephew, Inc.2002-10-09
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE (K022665)Hohenstein Enterprises, Inc.2002-10-09
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM (K022581)Becton, Dickinson & CO2002-10-09
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. (K022666)Arc Medical Supplies (Beijing) Co, Ltd.2002-10-09
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II (K020948)Smith & Nephew, Inc.2002-10-09
RITA SYSTEM (K021329)Rita Medical Systems2002-10-09
STOCKERT V172-28 VENOUS FEMORAL CANNULA (K022321)Stockert Instrumente GmbH2002-10-09
OCO DENTAL IMPLANT (5.0MM DIAMETER) (K023336)O Co., Inc.2002-10-09
VITA IN-CERAM YZ CUBES FOR CEREC (K022996)Vident2002-10-09
FOCUS RADIATION TREATMENT PLANNING SYSTEM (K020027)Computerized Medical Systems, Inc.2002-10-08
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 (K020507)Olympus Winter & Ibe GmbH2002-10-08
MODEL 4310 PSARRAY2 EEG ELECTRODE (K020670)Physiometrix, Inc.2002-10-08
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL (K023032)Bioresource Technology, Inc.2002-10-08
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 (K022565)Stereotaxis, Inc.2002-10-08
INNOVA AND INNOVA 2000 S (K022322)Ge Medical Systems, Inc.2002-10-08
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K022656)Trek Diagnostic Systems, Inc.2002-10-08
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES (K022228)Iridex Corp2002-10-08
STERRAD SEALSURE CHEMICAL INDICATOR TAPE (K022441)Advanced Sterilization Products2002-10-08
GETTIG DISPOSABLE SYRINGES (K022495)Gettig Pharmaceutical Instrument Co.2002-10-08
KONRAD, MODEL V.2.0 (K022307)Mrc Systems GmbH2002-10-08
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE (K022781)Industrial Clothings, Ltd.2002-10-08
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES (K021955)Datex-Ohmeda, Inc.2002-10-08
SIMPLIFY COMPACT RESUSCITATOR (K021716)Polymed (Xiamen) Plastic Industrial Co., Ltd.2002-10-08
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS (K022226)Altus Medical, Inc.2002-10-08
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST (K022946)Princeton BioMeditech Corp.2002-10-08
ARTEMIS (K021333)Ultralink, LLC2002-10-08
PULPDENT CALCIUM HYDROXIDE PREPARATION (K022734)Pulpdent Corporation2002-10-07
TRILUX, Z-TONE, ACRY ROCK (K022299)Ruthibras Imp. Exp. Com. DE Materiais Odontologico2002-10-07
EXOMIO, MODEL 1.1 (K022219)Medcom GmbH2002-10-07
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS (K022373)Cantor & Nissel , Ltd.2002-10-07
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM (K022207)Axya Medical, Inc.2002-10-04
ACUTEVENTILATOR (K012271)Impoex International, Ltd.2002-10-04
RHINOSTREAM RHINOMANOMETER MODULE (K022311)Rhino Metrics A/S2002-10-04
CANDELA SMOOTHBEAM LASER SYSTEM (K014128)Candela Corp.2002-10-04
PMX COMPACT RESUCITATOR (K021390)Cheen Houng Ent. Co. , Ltd.2002-10-04
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (K013525)Coloplast Corp.2002-10-04
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 (K022210)Cardiac Science, Inc.2002-10-04
KOKOMATE (K022276)Ferraris Respiratory, Inc.2002-10-04
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX (K022257)Vomed Volzer Medizintechnik GmbH & Co.2002-10-04
NBD CEMENT RESTRICTOR DEVICE (K021788)New Business Development, LLC2002-10-04
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT (K023124)Canon, Inc.2002-10-04
NUGEN FX SCREW (K023022)Bionx Implants, Inc.2002-10-04
PSA4000 EEG MONITOR WITH FRONTAL PSI (K020671)Physiometrix, Inc.2002-10-04
SYNCHRON LX I 725 CLINICAL SYSTEM (K023049)Beckman Coulter, Inc.2002-10-04
RHS ACETABULAR COMPONENT (K022382)Signal Medical Corp.2002-10-04
VANGUARD REPROCESSED PULSE OXIMETER SENSORS (K012344)Vanguard Medical Concepts, Inc.2002-10-04
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T (K023021)Smith & Nephew, Inc.2002-10-04
CLASSIC GREAT TOE IMPLANT (K023086)Nexa Orthopedics, Inc.2002-10-04
OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES (K022939)Osypka Medical, Inc.2002-10-03
RADIANALYZER, MODEL 12710 (K022188)Radi Medical Systems AB2002-10-03
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B (K022234)Arthrex, Inc.2002-10-03
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Every clearance here is in the API, with alerts when new ones post.