Atlas FDA

2002

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

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RecordFirmDate
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE (K023711)Acute Ideas Co. , Ltd.2002-11-21
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000 (K023585)Intravascular Incorporated2002-11-21
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE (K022799)Howmedica Osteonics Corp.2002-11-21
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 (K014269)Medtronic Functional Diagnostics A/S2002-11-21
ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K022860)Boston Scientific, Target2002-11-21
EQUILASE SYSTEM (K022464)Equilasers, Inc.2002-11-21
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 (K022916)K-Jump Health Co., Ltd.2002-11-21
6 CHANNEL BODY COIL (K023571)Siemens Medical Systems, Inc.2002-11-20
SONOLINE ANTARES ULTRASOUND SYSTEM (K023720)Siemens Medical Solutions USA, Inc.2002-11-20
OTI UNICONDULAR INTERPOSITIONAL SPACER (K022779)Osteoimplant Technology, Inc.2002-11-20
ASCENSIA DEX 2 DIABETES CARE SYSTEM (K023584)Bayer Corp.2002-11-20
CYNOSURE PHOTOGENICA SV (K021444)Cynosure, Inc.2002-11-20
IMAGECHECKER-CT WORKSTATION (K023003)R2 Technology, Inc.2002-11-20
QUICKLAB RSV (K021789)Integrated Biotechnology Corp.2002-11-20
SONOREAL 3D (K023473)Bio Medi Com2002-11-20
MONARC SLING SYSTEM (K023516)American Medical Systems, Inc.2002-11-19
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER (K020804)United States Surgical, A Division of Tyco Healthc2002-11-19
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O (K023698)Philips Medical Systems2002-11-19
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 (K023601)Rubicor Medical, Inc.2002-11-19
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS (K022798)Corin USA2002-11-19
INSOUND XT SERIES HEARING AID (K021867)Insound Medical, Inc.2002-11-19
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) (K023749)Philips Medical Systems2002-11-19
ELECSYS PROBNP IMMUNOASSAY (K022516)Roche Diagnostics Corp.2002-11-19
ORIA SPINAL CLIP SYSTEM (K021679)Ortho Tec, LLC2002-11-19
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 (K022841)Biomedical Life Systems, Inc.2002-11-19
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) (K013694)Nidek, Inc.2002-11-19
MANUAL TOUCHE SYSTEM (K022777)Onux Medical, Inc.2002-11-19
HIP MODULE FOR THE STEALTHSTATION SYSTEM (K021980)Medtronic Surgical Navigation Technologies2002-11-19
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM (K022783)Tensys Medical, Inc.2002-11-19
STORM TDX POWER WHEELCHAIR (K023589)Invacare Corp.2002-11-19
TILITE YG AND TILITE YGS (K023606)Tisport2002-11-19
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 (K022925)Biomedical Life Systems, Inc.2002-11-19
PHFW-10 (K022539)Pihsiang Machinery Mfg. Co., Ltd.2002-11-19
BIOBUCK CEMENT RESTRICTOR (K023680)Smith & Nephew, Inc.2002-11-19
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K023570)Medtronic Sofamor Danek2002-11-19
THE BIOPLATE BATTERY POWERED DRILL (K022986)Bioplate, Inc.2002-11-19
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687)Ciba Vision Corporation2002-11-19
EASY LIFE (K023521)Berkline Corp.2002-11-19
ASSUFIL (K021767)Assut Europe S.P.A.2002-11-19
GORE 3.0T TORSO ARRAY (K023679)W. L. Gore & Associates, Inc.2002-11-18
FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES (K022671)Hartalega Sdn Bhd2002-11-18
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN (K023635)Sri/Surgical Express, Inc.2002-11-18
MILLENNIUM MICROSURGICAL SYSTEM (K022760)Bausch & Lomb, Inc.2002-11-18
AMEDITECH IMMUTEST HCG PREGANCY TEST (K023126)Ameditech, Inc.2002-11-18
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 (K023337)Boston Scientific Corp2002-11-18
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K023184)Bayer Diagnostics Corp.2002-11-18
BAXTER ACCURA SYSTEM, MODEL 5M5660 (K021615)Baxter Healthcare Corp2002-11-18
IDI-STREP B ASSAY (K022504)Infectio Diagnostic, Inc.2002-11-18
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET (K014140)Sunder Biomedical Tech. Co., Ltd.2002-11-18
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K013913)Medtronic Percusurge, Inc.2002-11-15
CALGITROL AG SILVER ALGINATE WOUND DRESSING (K011618)Adri2002-11-15
HERMES OPERATING ROOM CONTROL CENTER (K023095)Computer Motion, Inc.2002-11-15
PTS PANELS LIPID PANEL TEST STRIPS (K023558)Polymer Technology Systems, Inc.2002-11-15
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (K022982)Med-Logics, Inc.2002-11-15
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E (K022821)Ideatrics, Inc.2002-11-15
PHASEAL (K023747)Carmel Pharma Ab.2002-11-15
VITALSAT SERIES (K011518)Beta Biomed Services, Inc.2002-11-15
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS (K023268)Phoenix Diagnostics, Inc.2002-11-15
CARDIOTOUCH-3000 (K023034)Bionet Company, Ltd.2002-11-14
LUTHER SAFETY HUBER NEEDLE SET (K021565)Luther Research Partners2002-11-14
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER (K021470)General Electric Medical Systems Information Techn2002-11-14
V TENS PLUS (K022731)Body Clock Health Care, Ltd.2002-11-14
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (K022753)Medical Device Services2002-11-14
SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 (K022934)Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits2002-11-14
VENTED CEMENT RESTRICTOR (K022729)Amedica Corp.2002-11-14
BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (K022900)John O. Butler Co.2002-11-14
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM (K023434)Dorex, Inc.2002-11-14
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE (K022740)Datex-Ohmeda2002-11-14
SKINTACT ECG ELECTRODE (K023503)Leonhard Lang GmbH2002-11-14
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL (K023437)Disco-O-Tech Medical Technologies, Ltd.2002-11-14
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION (K022769)Bionostics, Inc.2002-11-13
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST (K022501)Alfa Scientific Designs, Inc.2002-11-13
STELLAR SERIES SURGICAL LIGHTS WITH HERMES (K021585)Skytron, Div. the Kmw Group, Inc.2002-11-13
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM (K023498)Blackstone Medical, Inc.2002-11-13
MODIFICATION TO MONARCH SPINE SYSTEM (K023438)Depuyacromed2002-11-13
ORS-3000LD (K023282)O.R. Solutions, Inc.2002-11-13
FRESENIUS ICARE MONITORING SYSTEM (K021060)Fresenius Medical Care North America2002-11-13
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE (K023054)Mandala Health Care, LLC2002-11-13
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL (K023153)Ansell Healthcare Products, Inc.2002-11-13
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR (K022784)Syntex Healthcare Products Co., Ltd.2002-11-13
AMT POLYAXIAL PEDICLE SCREW (K022768)Micron Precision Engineering, Inc.2002-11-13
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 (K023433)Pharmacia Diagnostics GmbH & Co. KG2002-11-13
PK ZIP WING CUTTING DISSECTOR (K023493)Gyrus Medical, Inc.2002-11-13
QUANTIX/ND DEVICE (K023431)Cardiosonix, Ltd.2002-11-13
PHYSICAL MONITORING REGISTRATION UNIT (K022719)Maryrose Cusimano, Ph.D./Phil Reaston2002-11-13
MODIFICATION TO CLASSIC GREAT TOE IMPLANT (K023562)Nexa Orthopedics, Inc.2002-11-13
SPI EASY DENTAL IMPLANT ABUTMENT (K023645)Thommen Medical AG2002-11-13
MICROVASIVE PULMONARY GUIDEWIRE (K022059)Boston Scientific Corp2002-11-13
1075LD HUSH-SLUSH (K023283)O.R. Solutions, Inc.2002-11-13
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM (K022791)Synthes (Usa)2002-11-13
HEX-LOCK TEMPORARY ABUTMENT (K014050)Sulzer Dental, Inc.2002-11-13
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS (K023453)DePuy Orthopaedics, Inc.2002-11-13
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM (K023646)Exactech, Inc.2002-11-13
UNIVERSAL SYSTEM, MODEL QV-800 (K023008)Quantum Medical Imaging, LLC2002-11-13
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS (K023492)Gyrus Medical, Inc.2002-11-13
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K023504)Cook, Inc.2002-11-13
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING (K020703)Howmedica Osteonics Corp.2002-11-13
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML (K023444)Becton, Dickinson & CO2002-11-12
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE (K023159)Industrial Clothings, Ltd.2002-11-12
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178)Bayer Diagnostics Corp.2002-11-12
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Every clearance here is in the API, with alerts when new ones post.