Atlas FDA

2002

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

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RecordFirmDate
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) (K013596)Accumetrics, Inc.2002-05-16
IMMIX BONE GRAFT EXTENDER (K013764)Osteogenics Biomedical, Inc.2002-05-16
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) (K020608)Poly Vue Technolgies, Inc.2002-05-16
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES (K021001)Shanghai Glovmax Enterprise Co.,Ltd2002-05-16
EBI XFIX RAIL SYSTEM (K021031)Ebi, L.P.2002-05-16
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (K020956)Microtek Medical, Inc.2002-05-16
QACA IGG/IGM ELISA KIT HRP (K021192)Cheshire Diagnostics , Ltd.2002-05-16
MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER (K011726)Millenium Biologix, Inc.2002-05-16
SURGE-FREE ASPIRATION ADAPTER (K020734)Staar Surgical Co.2002-05-16
SYNTHES (USA) AUTOMATED TACK DRIVER (K021382)Synthes (Usa)2002-05-16
SUNSPEX TECHNOLOGIES MODEL SE 02 (K021371)Sunpex Technology Co., Ltd.2002-05-16
STERNGOLD 66, MODEL #1180230 (K021367)Sterngold2002-05-16
EPY-50 (K020513)Ddc Technologies, Inc.2002-05-16
PORTALLOY 54 (K021242)Wieland Dental + Technik GmbH & Co. KG2002-05-16
MTI ST#1 SILICONE PESSARY (K020512)Medical Technology and Innovations, Inc.2002-05-16
EBI AIS SPINE SYSTEM (K020887)Ebi, L.P.2002-05-16
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED (K021024)Instrumentation Laboratory CO2002-05-16
PHILIPS PLS9W/12/2P UVB (K021514)Philips Lighting Co.2002-05-16
APATIGHT-TCP BONE GRAFT SUBSTITUTE (K013966)Cerabio, LLC2002-05-16
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE (K021396)Wrp Specialty Products Sdn. Bhd.2002-05-16
APEX INTRAMEDULLARY NAIL SYSTEM (K020562)Magly Orthopedics, LLC2002-05-16
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES (K014235)Implant Innovations, Inc.2002-05-16
CARE IFC PLUS (K020516)Care Rehab, Inc.2002-05-16
ACCOMMODATOR WHEELCHAIR, MODEL #2000X (K021145)Marken International, Inc.2002-05-16
BCLEAR (K020591)Lumenis2002-05-16
CONSTELLATION CATHETERS, MODEL 8031M (K021232)Boston Scientific Corp2002-05-16
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 (K020847)Photo Medex, Inc.2002-05-16
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS (K020927)Bausch & Lomb2002-05-16
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) (K020398)Dade Behring, Inc.2002-05-16
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES (K020538)Boehringer Laboratories2002-05-15
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 (K021422)Philips Medical Systems2002-05-15
BIO-LOGIC ABAER CUB (K021215)Bio-Logic Systems Corp.2002-05-15
HERNIAMESH T-SLING (K020652)Herniamesh2002-05-15
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 (K021042)Thermo Forma, Inc.2002-05-15
ACON ONE STEP DRUG SCREEN TEST CARD (K020771)ACON Laboratories, Inc.2002-05-15
FORTAFLEX SURGICAL SLING (K021107)Organogenesis, Inc.2002-05-15
ERTAPENEM 10UG BBL SENSI-DISC (K020842)Becton, Dickinson & CO2002-05-15
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE (K021228)Guidant Corp.2002-05-15
VITAL SCIENTIFIC PT WITH CALCIUM (K020840)Vital Scientific N.V.2002-05-15
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 (K021175)Aerogen, Inc.2002-05-15
MODIFICATION TO SPARC SLING SYSTEM (K021263)American Medical Systems, Inc.2002-05-15
CEFOTAXIME (K020859)Trek Diagnostic Systems, Inc.2002-05-15
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS (K020633)Ls Rubber Sdn Bhd2002-05-15
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 (K021368)Medela AG2002-05-15
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (K020726)Dukal Corp.2002-05-15
UNI-PATCH ULTRASOUND COUPLING GEL (K021132)The Ludlow Company LP2002-05-15
SURGASSIST FLEXSHAFT 2, MODEL FS2 14 (K021249)Power Medical Interventions, Inc.2002-05-15
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM (K021059)Syntex Healthcare Products Co., Ltd.2002-05-14
SIMPLICITY QD EASY P INFUSION SET (K021296)Sterling Medivations, Inc.2002-05-14
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (K020489)Tosoh Medics, Inc.2002-05-14
MICROJET CRONO PAR AND CRONO APO-GO (K013840)Cane S.R.L.2002-05-14
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS (K013587)Babies Best, Inc.2002-05-14
MS-30 LATERAL FEMORAL STEM (K020713)Sulzer Orthopedics, Inc.2002-05-14
STERISHARP 3-GALLON RSDC, MODEL RSDC3G (K020664)Sterilogic Waste Systems, Inc.2002-05-14
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 (K021350)Abbott Laboratories2002-05-14
HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) (K021023)Instrumentation Laboratory CO2002-05-14
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM (K021058)Syntex Healthcare Products Co., Ltd.2002-05-14
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (K020618)Aalto Scientific, Ltd.2002-05-14
I-STAT PROTHROMBIN TIME TEST (K020355)I-Stat Corporation2002-05-14
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES (K021308)Glovco (M) Sdn. Bhd.2002-05-14
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) (K021022)Instrumentation Laboratory CO2002-05-14
IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (K020816)Diagnostic Chemicals , Ltd.2002-05-14
LATEX SURGEONS GLOVE (POWDERED) (K014278)Brightway Gloves Pvt. , Ltd.2002-05-14
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823)Sanquin Blood Supply Foundation2002-05-14
NYCOCARD CRP (K013787)Primus Corp.2002-05-14
REPROCESSED COMPRESSION LIMB SLEEVES (K012658)Surgical Instruments Service and Savings, Inc.2002-05-14
SL-PLUS LATERALIZED STEM (K021178)Plus Orthopedics2002-05-14
EVERSTICK ORTHO (K021126)Stick Tech , Ltd.2002-05-13
MODIFICATION TO 30 EXTENSION SET (K021395)Churchill Medical Systems, Inc.2002-05-13
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 (K021246)Sensidyne, Inc.2002-05-13
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL (K021416)Dentsply Intl.2002-05-13
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM (K021226)Medtronic Sofamor Danek2002-05-13
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS (K020615)Howmedica Osteonics Corp.2002-05-13
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 (K020579)Aaron Medical Industries2002-05-13
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR (K021182)Biomet, Inc.2002-05-13
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES (K020719)Power Medical Interventions, Inc.2002-05-10
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 (K020254)Lin-Zhi International, Inc.2002-05-10
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER (K020453)Palomar Medical Technologies, Inc.2002-05-10
OCTEIA 25-HYDROXY VITAMIN D (K021163)Immunodiagnostic Systems , Ltd.2002-05-10
FORTAFLEX SURGICAL MESH (K021105)Organogenesis, Inc.2002-05-10
THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG (K020445)The Electrode Store, Inc.2002-05-10
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) (K013886)Advanced Diagnostics, Inc.2002-05-10
NSI HEXED AND NON-HEXED IMPLANT SYSTEM (K020617)Nsi2002-05-10
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) (K020763)Lin-Zhi International, Inc.2002-05-10
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (K021258)Germ Terminator Corporation2002-05-10
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM (K020449)Cardionow, Inc.2002-05-10
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL (K021413)Dentsply Intl.2002-05-10
FUJIREBIO DIAGNOSTICS CA 19-9 RIA (K020566)Fujirebio Diagnostics,Inc.2002-05-09
MICROJET CRONO H (K013855)Cane S.R.I.2002-05-09
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR (K021135)Ge Medical Systems Information Technologies2002-05-09
VORTEX VALVED HOLDING CHAMBER (K020944)Pari Innovative Manufacturers, Inc.2002-05-09
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN (K020561)Tomtec Imaging Systems GmbH2002-05-09
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (K020430)Diatek, Inc.2002-05-09
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (K021339)Trek Diagnostic Systems, Inc.2002-05-09
GATIFLOXIN (K020762)Trek Diagnostic Systems, Inc.2002-05-09
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (K021166)Acmi-Circon Corporation2002-05-09
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS (K012132)Cantor & Nissel , Ltd.2002-05-09
OHMEDA MEDICAL GIRAFFE INCUBATOR (K020547)Ohmeda Medical2002-05-09
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER (K021054)Codonics, Inc.2002-05-09
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Every clearance here is in the API, with alerts when new ones post.