Atlas FDA

2002

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

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RecordFirmDate
BACTEC MGIT 960 SIRE KITS (K014123)Becton, Dickinson & CO2002-04-19
BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (K020079)Blade Works, Inc.2002-04-19
QAB2A IGM ELISA KIT (K020694)Cheshire Diagnostics , Ltd.2002-04-19
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (K020919)AtriCure, Inc.2002-04-19
XR PRIMER 2 (K020303)Kerr Dental Materials Center2002-04-19
BACT/ALERT FN CULTURE BOTTLE (K020815)bioMerieux, Inc.2002-04-18
VERSALAB APM (K013281)Nicolet Biomedical2002-04-18
BACT/ALERT PF CULTURE BOTTLE (K020923)bioMerieux, Inc.2002-04-18
BACT/ALERT SA CULTURE BOTTLE (K020931)bioMerieux, Inc.2002-04-18
NXSTAGE THERAPY SYSTEM (K020858)Nxstage Medical, Inc.2002-04-17
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 (K020864)Edwards Lifesciences, LLC2002-04-17
EMULATE FAST SET AND EMULATE REGULAR SET (K020242)Cavex Holland BV2002-04-17
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (K014274)Nidek, Inc.2002-04-17
PULPDENT POST CEMENT (K020481)Pulpdent Corporation2002-04-17
COMPEX SPORT (K011880)Compex S.A.2002-04-17
TRULINE REINFORCED VALVED INFUSION CATHETER (K021139)Micro Therapeutics, Inc.2002-04-17
UTERINE INJECTOR (K020292)Catheter Research, Inc.2002-04-17
MYALLERGYTEST SYSTEM (K020387)Immunetech Corporation2002-04-17
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD (K021077)Megadyne Medical Products, Inc.2002-04-17
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049)Ge Oec Medical Systems2002-04-17
TAMPONADE UTERINE BALLOON CATHETER SET (K013597)Cook Ob/Gyn2002-04-17
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X (K020940)Sutura, Inc.2002-04-17
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) (K020506)Dade Microscan, Inc.2002-04-17
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER (K020890)St Jude Medical2002-04-17
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) (K020319)Dade Behring, Inc.2002-04-17
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS (K020947)Smith & Nephew, Inc.2002-04-17
PULPDENT GLAZE (K020432)Pulpdent Corporation2002-04-17
NICOLET ELECTROCAUTERY DETECTOR (K020955)Nicolet Biomedical, Inc.2002-04-17
4 ALL (DW286A) (K020253)Ivoclar Vivadent, Inc.2002-04-17
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (K013882)OraSure Technologies, Inc.2002-04-17
KSEA FIBERSCOPE (K011793)KARL STORZ Endoscopy-America, Inc.2002-04-17
BACT/ALERT FA CULTURE BOTTLE (K020813)bioMerieux, Inc.2002-04-17
CHIN ELECTRODE (K020468)Dymedix, Inc.2002-04-16
ACTICHROME HEPARIN (ANTI-FIIA) (K013637)American Diagnostica, Inc.2002-04-16
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (K020951)Ackrad Laboratories2002-04-16
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM (K021076)Primeline Medical Products, Inc.2002-04-16
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM (K020963)Biomet Orthopedics, Inc.2002-04-16
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 (K013621)Becton Dickinson Infusion Therapy Systems, Inc.2002-04-16
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM (K013300)Technology Delivery Systems, Inc.2002-04-16
INTRASTENT LD (LARGE DIAMETER) STENT (K020528)Sulzer Intratherapeutics, Inc.2002-04-16
COBRA COOLED SURGICAL PROBE, MODEL 1596X (K021046)Boston Scientific Corp2002-04-16
ROCHE ONLINE THEOPHYLLINE (K020740)Roche Diagnostics Corp.2002-04-16
SYNTHES VERTEBRAL SPACER TI (K020152)Synthes (Usa)2002-04-16
NBX - NON-BRIDGING EXTERNAL FIXATOR (K020905)Biomet Orthopedics, Inc.2002-04-15
LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878)Bio-Rad2002-04-15
WOUND PROTECTOR/RETRACTOR (K020435)Applied Medical Resources Corp.2002-04-15
SYNTHES DUAL-OPENING USS (K020517)Synthes (Usa)2002-04-15
L.A.M. IPM WOUND GEL (K020325)L.A.M. Pharmaceutical, Corp.2002-04-15
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM (K020145)Orthopaedic Innovations, Inc.2002-04-15
CARESIDE TRGLYCERIDE (K020488)Careside, Inc.2002-04-15
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM (K003916)Scandia Manufacturing , Ltd.2002-04-15
CONSENSUS ACETABLAR SHELL, TI COATED (K020153)Hayes Medical, Inc.2002-04-15
SERRALNYL (K020146)Serral, S.A. DE C.V.2002-04-15
SPIRAL RADIUS 90-D RODDING SYSTEM (K020134)United States Surgical, A Division of Tyco Healthc2002-04-15
DENTITION INTEGRATING MATERIAL (K020287)Pulpdent Corporation2002-04-12
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP (K012650)Hygia Health Services, Inc.2002-04-12
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE (K011903)Vivometrics, Inc.2002-04-12
APC PLUS ADHESIVE (K020394)3M Unitek2002-04-12
LIQUICHEK URINE CHEMISTRY CONTROL (K020817)Bio-Rad Laboratories, Inc.2002-04-12
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP (K012657)Hygia Health Services, Inc.2002-04-12
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (K020575)Elan Diagnostics2002-04-12
CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 (K020135)Conmedcorp2002-04-12
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K020809)Cordis Corp.2002-04-12
RPI SKIN OR AIR TEMPERATURE PROBE (K020219)Replacement Parts Industries, Inc.2002-04-12
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 (K020276)Ethicon Endo-Surgery, Inc.2002-04-12
DEPILASE TWIN YAG LASER SYSTEM (K020697)Depilase Group , Ltd.2002-04-12
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS (K020662)Ortho-Clinical Diagnostics2002-04-12
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 (K012654)Hygia Health Services, Inc.2002-04-12
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) (K020330)Pacific Consolidated Industries Llp2002-04-12
MITYVAC MERLIN, MODEL 10027 (K020447)Prism Enterprises, Inc.2002-04-12
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 (K012651)Hygia Health Services, Inc.2002-04-12
EFILM WORKSTATION WITH MODULES (K020995)Efilm Medical, Inc.2002-04-12
ABP-2000 G-3 (K021029)Biotrac, Inc.2002-04-12
CONMED SYSTEM 5000 ESU (K020186)Conmedcorp2002-04-12
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 (K020824)Boston Scientific Corp2002-04-12
STATIC CRANIOPLASTY ORTHOSIS (K020448)Eastern Cranial Affiliates2002-04-12
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY (K020496)Sysmex Corporation of America2002-04-12
AXILLARY ACCESS ARTERIAL CANNULA (K002578)Edwards Lifesciences, LLC2002-04-11
INTRAORAL CAMERA ME-15 (K020206)Dent Corp. Research & Development2002-04-11
MODIFICATION TO FOX PTA CATHETER (K020854)Jomed AG2002-04-11
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER (K013160)Spire Biomedical, Inc.2002-04-11
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (K011068)Rhigene, Inc.2002-04-11
ZOLL PAD WITH CPR AID (K011541)Zoll Medical Corp2002-04-11
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB (K012956)Hygia Health Services, Inc.2002-04-11
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE (K020099)Biolitec, Inc.2002-04-11
AVON PATELLAR COMPONENT (K020841)Howmedica Osteonics Corp.2002-04-11
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) (K020363)Great Glove Sdn Bhd2002-04-10
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER (K020106)Gish Biomedical, Inc.2002-04-10
BIOCELLECT -PERIO (K020396)Imtec Corp.2002-04-10
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR (K020089)The Kendall Company2002-04-10
UD-1000 ULTRASONIC A/B SCANNER (K020151)Tomey Corp. USA2002-04-10
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN (K020990)Sterling Medivations, Inc.2002-04-10
SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL (K020343)Power Medical Interventions, Inc.2002-04-10
SIMPLICITY EASY SOFT INFUSION SET (K020912)Sterling Medivations, Inc.2002-04-10
IMMEDIATE STABILIZING DEVICE (ISD) (K011524)O Co., Inc.2002-04-10
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS (K020832)Arthrocare Corp.2002-04-09
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER (K014025)Hommed, LLC2002-04-09
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, (K012758)Circon Video2002-04-09
ASTRONOMER PLUS SYSTEM (K013349)Ep Technologies, Inc.2002-04-09
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Every clearance here is in the API, with alerts when new ones post.