Atlas FDA

2002

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

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RecordFirmDate
DIDECO ELECTA (K020647)Dideco S.P.A.2002-09-05
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM (K022647)Triad Medical, Inc.2002-09-05
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K021891)Zimmer, Inc.2002-09-05
MEDRAD TRANSFER SET (K022431)Medrad, Inc.2002-09-05
HRW-63-INT WRIST ARRAY COIL (K022588)Mri Devices Corp.2002-09-04
QUINTON Q-CATH, MODEL 000460 (K021906)Quinton, Inc.2002-09-04
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER (K022621)Boston Scientific Corp2002-09-04
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K021907)Igel Vision Care Pte , Ltd.2002-09-04
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE (K022092)Syntex Healthcare Products Co., Ltd.2002-09-03
CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 (K021848)Clarus Medical, LLC2002-09-03
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE (K022146)Syntex Healthcare Products Co., Ltd.2002-09-03
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) (K022042)Cardeon Corp.2002-09-03
EYEFEEL OPHTHALMIC WARMER (K021843)Bio-Lipid, Inc.2002-09-03
LUCIUS 62 (K021948)Lucius Metals Com.2002-09-03
SYNTHES MIDFACE DISTRACTOR (K022005)Synthes (Usa)2002-09-03
RAICHEM LIPID CALIBRATOR (K022767)Hemagen Diagnostics, Inc.2002-09-03
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE (K022088)Syntex Healthcare Products Co., Ltd.2002-09-03
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON (K002612)C.R. Bard, Inc.2002-09-03
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE (K022090)Syntex Healthcare Products Co., Ltd.2002-09-03
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES (K021847)Biopsy Sciences, LLC2002-09-03
MODIFICATION TO THE MAESTRO SYSTEM (K022795)BioHorizons Implant Systems, Inc.2002-08-30
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM (K022543)Arthrocare Corp.2002-08-30
PVP (POLYVINYLPYRROLIDONE) (K022590)<Genx> Intl., Inc.2002-08-30
ENDOSSEOUS IMPLANT (K021355)Branemark Integration AB2002-08-30
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST (K022564)Alfa Scientific Designs, Inc.2002-08-30
DATEX-OHMEDA HMEF 500 (K021265)Datex-Ohmeda2002-08-30
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S (K021493)Andersen Products, Inc.2002-08-30
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED (K021162)Sigma Diagnostics, Inc.2002-08-30
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS (K021781)Chay Medical, LLC2002-08-30
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) (K021837)Entific Medical Systems, Inc.2002-08-30
SLEEPFLO, MODEL 101501 (K020607)Biomec, Inc.2002-08-30
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 (K022563)Implex Corp.2002-08-30
VERACAM (K021083)Lumalite, Inc.2002-08-30
RANDOX LIPID CONTROL (K022591)Randox Laboratories, Ltd.2002-08-30
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 (K021916)Harmac Medical Products, Inc.2002-08-29
SAFEPRO SAFETY SYRINGE (K022063)Formosa Medical Devices, Inc.2002-08-29
NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS (K021080)Cardio Med Supplies, Inc.2002-08-29
ABR-2000 (K020360)Meridian Co., Ltd.2002-08-29
WS-501 HEAT LAMP (K013197)Lhasa Medical, Inc.2002-08-29
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654)Roche Diagnostics Corp.2002-08-29
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) (K013756)Argus Biomedical Pty, Ltd.2002-08-29
ACETAL (K022032)Inovativ, LLC2002-08-29
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM (K021807)Grass Instrument Co.2002-08-29
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS (K022569)Medical Bio Care Sweden AB2002-08-29
JENSEN GOLD FOIL (K022206)Jensen Industries, Inc.2002-08-29
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM (K021988)Medrad, Inc.2002-08-29
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR (K022568)Medical Bio Care Sweden AB2002-08-29
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 (K022031)Draeger Medical, Inc.2002-08-29
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (K022260)Isolation Systems, Inc.2002-08-29
RADIOSYSTEM/NT, MODEL 80-13020 (K020320)Styker Instruments2002-08-28
SR IVOCRON (K013869)Ivoclar Vivadent, Inc.2002-08-28
INTROCAN SAFETY IV CATHETER (K020785)B.Braun Medical, Inc.2002-08-28
POLY-CARB (K022030)Inovativ, LLC2002-08-28
SPERMASSIST (K022443)Nidacon International AB2002-08-28
HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS (K022334)<Genx> Intl., Inc.2002-08-28
MODIFICATION TO TENOR SPINAL SYSTEM (K022191)Medtronic Sofamor Danek, Inc.2002-08-28
THE AUTOTAC SYSTEM TITANIUM TACK (K022790)BioHorizons Implant Systems, Inc.2002-08-28
PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM (K021804)Medtronic Vascular2002-08-28
RF TENT (K022157)Odin Medical Technologies , Ltd.2002-08-28
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 (K022718)Guidant Corporation, Cardiac Surgery2002-08-28
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE (K021834)Mle, Inc.2002-08-28
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER (K013003)Advanced Sterilization Products2002-08-28
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) (K022352)<Genx> Intl., Inc.2002-08-28
ACIDIFIED TYRODES SOLUTION (K022547)<Genx> Intl., Inc.2002-08-28
7F LAUNCHER GUIDE CATHETER (K022764)Medtronic Vascular2002-08-28
REFLECTION MODIFIED ACETABULAR SHELLS (K022556)Smith & Nephew, Inc.2002-08-28
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX (K020550)Datascope Corp.2002-08-28
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K022491)Cliniqa Corporation2002-08-27
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 (K021760)Orthosoft, Inc.2002-08-27
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) (K022623)Depuyacromed2002-08-27
FONIX, MODEL 7000 (K022510)Frye Electronics, Inc.2002-08-27
3A DENTAL IMPLANT SYSTEM (K011879)Osseco Biosource, Ltd.2002-08-27
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 (K021759)Medcomp2002-08-27
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
APL IGA ELISA KIT (K021398)Louisville Apl Diagnostics, Inc.2002-08-27
TAILWIND (K022704)Deltaglide2002-08-27
PALMLIGHT (K020057)CAO Group, Inc.2002-08-27
PROTEIN S AC (K022290)Dade Behring, Inc.2002-08-27
VERTE-STACK SPINAL SYSTEM (K021791)Medtronic Sofamor Danek2002-08-26
CERANUM 87 (K021947)Lucius Metals Com.2002-08-26
TEMPFIX EXTERNAL FIXATION SYSTEM (K021933)DePuy Orthopaedics, Inc.2002-08-26
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 (K020529)A-Med Systems, Inc.2002-08-26
BNF (K021782)Aap Implantate AG2002-08-26
REPHRESH VAGINAL GEL (K021737)Columbia Laboratories, Inc.2002-08-26
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) (K021777)Gyrus Ent LLC2002-08-26
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) (K022601)Perusahaan Getah Asas Sdn. Bhd.2002-08-26
MODIFICATION TO AVALON CUP SYSTEM (K022711)Orthopedic Source, Inc.2002-08-26
AART CALF IMPLANT (K022511)Aesthetic and Reconstructive Technologies, Inc.2002-08-26
ALLGRAD 45 AND 90 CELL SEPARATION MEDIA (K022330)<Genx> Intl., Inc.2002-08-26
TITANIUM ANKLE ARTHRODESIS NAIL (K021786)Biomet, Inc.2002-08-26
2MM PEDIATRIC FLEX NAIL (K022531)Biomet, Inc.2002-08-26
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) (K022530)Hycare Intl. Co., Ltd.2002-08-26
S2 TIBIAL NAIL (K022481)Howmedica Osteonics Corp.2002-08-26
ACCOLADE C FEMORAL STEMS (K022555)Howmedica Osteonics Corp.2002-08-26
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K021819)Lifescan, Inc.2002-08-23
ALLGRAD AND ALLGRAD100 (K022335)<Genx> Intl., Inc.2002-08-23
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 (K022507)Datex-Ohmeda2002-08-23
ENOXAPARIN TEST CARD (K013305)Cardiovascular Diagnostics, Inc.2002-08-23
SURGISIS STAPLE LINE REINFORCEMENT (K022044)Cook Biotech, Inc.2002-08-23
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR (K020400)Meps, LLC2002-08-23
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Every clearance here is in the API, with alerts when new ones post.