Atlas FDA

2002

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

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RecordFirmDate
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (K020979)Dade Behring, Inc.2002-06-27
SOFT PLUG ABSORBABLE PLUG-SA (K013613)Oasis Medical, Inc.2002-06-27
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (K021801)Bio-Logic Systems Corp.2002-06-27
H12+HOLTER RECORDER (K021373)Mortara Instrument, Inc.2002-06-27
RDI HS CRP KIT (K021609)Reference Diagnostics, Inc.2002-06-27
EXTENSION SET LIGHT-SAFE, MODEL BC565 (K021480)Codan US Corp.2002-06-27
RDI HS CRP CALIBRATOR SET (K021607)Reference Diagnostics, Inc.2002-06-27
L.E.DEMETRON (K021797)Sybron Dental Specialties, Inc.2002-06-27
ENDIUS ATAVI SYSTEM (K021748)Endius, Inc.2002-06-26
CEMENTED FEMORAL HEAD RESURFING DEVICE (K021799)Biomet Orthopedics, Inc.2002-06-26
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 (K021036)Intuitive Surgical, Inc.2002-06-26
DUET SUTURE ANCHOR (K020056)Bionx Implants, Ltd.2002-06-26
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER (K021832)Biomet, Inc.2002-06-26
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) (K021879)Depuyacromed2002-06-26
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX (K014114)Nipro Diabetes Systems, Inc.2002-06-26
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM) (K021880)Depuyacromed2002-06-26
T2 FEMORAL NAIL (K021744)Howmedica Osteonics Corp.2002-06-26
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM (K021137)Sanarus Medical, Inc.2002-06-26
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K021684)Bioplate, Inc.2002-06-26
GARD FILTER, COMBIGARD FILTE / HME (K014281)Munktell Filter AB2002-06-26
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER (K020974)Environmental Tectonics Corp.2002-06-26
WARMER 2000LD (K021289)O.R. Solutions, Inc.2002-06-26
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM (K021211)Sanarus Medical, Inc.2002-06-26
AUTOPAL 50 (K021733)Wieland Dental + Technik GmbH & Co. KG2002-06-26
JUMP START, MODEL 970300 (K021168)Medical Research Laboratories, Inc.2002-06-26
BACSTOP FILTER,BACSTOP FILTER/HME (K014282)Munktell Filter AB2002-06-26
KAVO QUATTROCARE (K012308)Kavo America2002-06-26
ERA IMPLANT (K021045)Sterngold2002-06-26
CONMED HEATWAVE HAND-CONTROLLED ELETRODE (K021299)Conmedcorp2002-06-26
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K021034)Tfx Medical, Inc.2002-06-26
KSEA NEUROENDOSCOPES AND ACCESSORIES (K021050)KARL STORZ Endoscopy-America, Inc.2002-06-26
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM (K021227)Zap Lasers, LLC2002-06-26
CRITERTION, MODEL #1067511 (K021741)Sterngold2002-06-26
BELIMED STEAM STERILIZER, MODEL TOP 5000 (K021223)Sauter AG2002-06-26
BMN I TYPE MARROW ASPIRATION NEEDLE (K020987)H.S. Hospital Service S.R.L.2002-06-25
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K020985)Tfx Medical, Inc.2002-06-25
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL (K021930)Bionostics, Inc.2002-06-25
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM (K021012)Quality Medical Solusions, LLC2002-06-25
TITANIUM CANNULATED INTERFERENCE SCREW (K021030)Future Medical Systems, Inc.2002-06-25
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I (K021241)Sysmex Corporation of America2002-06-25
UHI-3 HIGH FLOW INSUFFLATION UNIT (K014166)Olympus Optical Co., Ltd.2002-06-25
MODIFICATION TO PARA 5X (K021922)Streck Laboratories, Inc.2002-06-25
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (K020296)Apothecary Products, Inc.2002-06-25
REPROCESSED EXTERNAL FIXATION DEVICE (K012623)Alliance Medical Corp.2002-06-24
CHOLESTEROL 1, 2, 3 (K014018)Imi2002-06-24
REPROCESSED EBI EXTERNAL FIXATION DEVICES (K012645)Alliance Medical Corp.2002-06-24
REPROCESSED EXTERNAL FIXATION DEVICE (K012634)Alliance Medical, Inc.2002-06-24
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES (K012648)Alliance Medical Corp.2002-06-24
GLUCOPRO EVO INFUSION PUMP (K013309)Nipro Diabetes Systems, Inc.2002-06-24
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE (K014009)Tanita Corp. of America2002-06-24
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL (K020996)Medefil, Inc.2002-06-24
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML (K020666)Baxter Healthcare Corp2002-06-24
M2376 DEVICELINK SYSTEM (K021912)Philips Medical Systems, Inc.2002-06-24
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT (K020205)Getinge/Castle, Inc.2002-06-24
MEDICA EASYQC HEMATOCRIT CONTROL (K021924)Bionostics, Inc.2002-06-24
CARDEON AEGIS CATHETER (K013593)Cardeon Corp.2002-06-24
SUBDURAL STRIP ELECTRODE (K021144)Nicolet Biomedical, Inc.2002-06-24
DIMENSION TPSA CALIBRATOR, MODEL #RC459 (K020980)Dade Behring, Inc.2002-06-21
QUPID PLUS E.R. (K020378)Stanbio Laboratory2002-06-21
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (K021043)Gramsmed, LLC2002-06-21
ABSORBENT ANTIMICROBIAL WOUND DRESSING (K013814)Convatec, A Division of E.R. Squibb & Sons2002-06-21
VISUCAM (K021787)Carl Zeiss Ophthalmic Systems, Inc.2002-06-21
CANDELA CBEAM PULSED DYE LASER SYSTEM (K020958)Candela Corp.2002-06-21
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K021729)Sulzer Intratherapeutics, Inc.2002-06-21
HORIZONS HOT BIOPSY FORCEPS (K021706)Horizons Intl. Corp.2002-06-21
CINESCAN S (K021683)Quantel Medical2002-06-21
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 (K021701)Power Medical Interventions, Inc.2002-06-21
RT-PLUS PE INSERT CLAMP (K021714)Plus Orthopedics2002-06-21
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN (K021184)Dade Microscan, Inc.2002-06-20
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL (K020999)Medefil, Inc.2002-06-20
TIPOWER POWERDRIVE AND RIMPOWER X & SX (K020539)Tisport2002-06-20
NIVEOUS LIQUID DAM (K021613)Shofu Dental Corp.2002-06-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K021627)Trek Diagnostic Systems, Inc.2002-06-20
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM (K021695)Ebi, L.P.2002-06-20
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER (K020639)Tisport2002-06-20
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (K020967)Terumo Cardiovascular Systems Corp.2002-06-20
EQUALIZER BALLOON CATHETER (K021721)Boston Scientific Corp2002-06-20
FOREX CORPORATION, OPTIMA, SPINAL SYSTEM (K020279)Forex Corp.2002-06-20
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL (K021008)Advanced Orthopaedic Solutions, Inc.2002-06-20
EQUATION FIXATION SYSTEM (K013962)Medtronic Sofamor Danek, Inc.2002-06-20
WORKBENCH BY <GENX> (K020560)Genx Intl., Inc.2002-06-19
SLEEP PAT 200 DEVICE (K010156)Itamar Medical (C.M.) 1997 , Ltd.2002-06-19
DEVILBISS PD1000 (K020329)Sunrise Medical Hhg, Inc.2002-06-19
PALOMAR LUXG HANDPIECE (K020941)Palomar2002-06-19
OXYGEN TREATMENT HOOD (K011592)Amron International Diving Supply, Inc.2002-06-19
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA (K013896)Defibtech, LLC2002-06-19
LEESPEC DISPOSABLE VAGINAL SPECULUM (K021017)Itl Corporation Pty, Ltd.2002-06-19
HANSATOME EXCELLUS MICROKERATOME (K021640)Bausch & Lomb, Inc.2002-06-19
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P (K021886)Olympus Optical Co., Ltd.2002-06-19
ELEMENTS DIAGNOSTIC UNIT (K021298)Sybron Endo/Analytic2002-06-19
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 (K021567)Arrow Intl., Inc.2002-06-19
UNIDRIVE II PLUS DISPOSABLE TUBING SET (K021811)Mtp Medical Technical Promotion GmbH2002-06-19
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR (K021089)Nellcor Puritan Bennett, Inc.2002-06-19
REMSTAR PRO WITH C-FLEX CPAP SYSTEM (K021861)Respironics, Inc.2002-06-19
GLO-SPEC I, II AND III (K020959)Sol Weiss MD, Inc.2002-06-19
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K021449)Lin-Zhi International, Inc.2002-06-18
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (K020335)Olympic Medical Corp.2002-06-18
VIVAWAVE MICROWAVE SYSTEM (K011676)Vivant Medical, Inc.2002-06-18
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM (K021066)Micro Therapeutics, Inc.2002-06-18
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 (K021680)Invacare Corp.2002-06-18
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Every clearance here is in the API, with alerts when new ones post.