Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
INBODY AP1 BODY COMPOSITION ANALYZER (K023478)Biospace Co.,Ltd2003-05-13
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER (K031259)Getinge USA, Inc.2003-05-12
RANDOX AMMONIA (K030873)Randox Laboratories, Ltd.2003-05-12
ELECSYS LH CALSET II (K031299)Roche Diagnostics Corp.2003-05-12
COOLTOUCH ND: YAG LASER SYSTEM (K030453)New Star Lasers, Inc.2003-05-12
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K031330)Masimo Corp.2003-05-12
CELL-DYN 1800 SYSTEM (K030513)Abbott Laboratories2003-05-12
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (K030775)Immuno Concepts, N.A. , Ltd.2003-05-12
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (K021813)Hydrocision, Inc.2003-05-09
OPAQUE HERRICK LACRIMAL PLUG (K030300)Lacrimedics, Inc.2003-05-09
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (K030417)Philips Medical Systems2003-05-09
POWERLITE 600 EP SYSTEM (K030423)Preswede AB2003-05-09
STACKED ABR FOR NAVIGATOR PRO (K030907)Bio-Logic Systems Corp.2003-05-09
OSTEOMED 2.0 LOCKING PLATES AND SCREWS (K030448)Osteomed LP2003-05-09
HERO (K021230)Medical Decision Networks2003-05-09
TRANSVAGINAL DOPPLER PROBE (K031358)Vascular Control Systems, Inc.2003-05-09
ETCHANT 40% (K030743)Confi-Dental Products Co.2003-05-09
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 (K031289)Sunrise Medical, Inc.2003-05-09
IGI-SYSTEM (K023424)Denx Advanced Dental Systems2003-05-09
DEPILASE YAG LASE PLUS LASER SYSTEM (K030506)Depilase Group , Ltd.2003-05-09
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR (K030680)Spsmedical Supply Corp.2003-05-09
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 (K023338)Fms, Finapres Medical Systems BV2003-05-09
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST (K030443)Nastech Pharmaceutical Company, Inc.2003-05-09
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (K031008)Aesculap2003-05-09
LAPAROSHIELD CONDITIONED INSUFFLATION SET (K030469)Pall Medical2003-05-09
C3 PATIENT MONITOR (K030931)Analogic Corp.2003-05-09
MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL (K030776)Discus Dental, Inc.2003-05-09
DIATEK CANNON-CATHETER, MODEL CC5500 (K022662)Arrow Intl., Inc.2003-05-09
SMARTXIDE (K031224)Cynosure, Inc.2003-05-09
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 (K031347)Olympus Optical Co., Ltd.2003-05-09
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 (K031156)Orthosoft, Inc.2003-05-09
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS (K022978)Case Medical, Inc.2003-05-09
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A (K030561)Mytech Technology Co., Ltd.2003-05-09
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K031293)Shijiazhuang Eversharp Plastic Products Co., Ltd.2003-05-09
HEADFIX (K030439)Medical Intelligence Medizintechnik GmbH2003-05-08
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL (K031056)Usa Instruments, Inc.2003-05-08
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 (K030573)Bd Vacutainer Systems Preanalyical Solutions2003-05-08
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY (K031089)W. L. Gore & Associates, Inc.2003-05-08
PD CASTA-H (K030632)Mountain Medico, Inc.2003-05-07
ARTEGRAL AND POLYSTAR SELECTION (K030588)Merz Dental GmbH2003-05-07
CO2 CLIP (K023820)Bregas AB2003-05-07
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI (K023648)Sun Biomedical Laboratories, Inc.2003-05-06
READI-LOAD SYSTEM, MODEL PSS 1820RL (K022389)Worldwide Medical Technologies, LLC2003-05-06
BELLEGLASS POINT 4 (K030646)Kerr Dental Materials Center2003-05-06
LAC-MAC LIMITED INNERBLOC O.R. GOWN (K030536)Lac Mac, Ltd.2003-05-06
RTA MODEL D RETINAL THICKNESS ANALYZER (K031312)Talia Technology , Ltd.2003-05-06
SURETEMP PLUS (K030580)Welch Allyn, Inc.2003-05-06
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH (K030450)J. Morita USA, Inc.2003-05-06
CARD EP (K031261)GE Medical Systems2003-05-06
SURGICAL SIMPLEX P WITH TOBRAMYCIN (K014199)Howmedica Osteonics Corp.2003-05-06
PEDIATRIC CENTRAL VENOUS CATHETER KIT (K023253)B.Braun Medical, Inc.2003-05-06
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER (K023759)Sonomedica2003-05-06
ARAMIS II DERMATOLOGICAL LASER (K023734)Quantel Medical2003-05-06
CT COLONOGRAPHY (K023943)Ge Medical Systems, Inc.2003-05-06
LUMINEXX ENDOSCOPIC BILIARY STENT (K031186)C.R. Bard, Inc.2003-05-06
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (K023615)Gambro Renal Products2003-05-06
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E (K031072)Shanghai Palomar Mountain Industries, Inc.2003-05-06
KALAZAR DETECT (K023483)Inbios Intl., Inc.2003-05-06
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (K022062)Impact Instrumentation, Inc.2003-05-06
EK-PRO ARRHYTHMIA DETECTION ALGORITHM (K031320)Ge Medical Systems Information Technologies2003-05-06
MONO-SWIFT (K030786)Cp Medical2003-05-06
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270)Beckman Coulter, Inc.2003-05-06
PRIMA III TOTALSENSE TORSO COIL (K030371)Usa Instruments, Inc.2003-05-05
CDR PANX, MODEL 4792 (K031291)Schick Technologies, Inc.2003-05-05
SOFT-TOUCH TENS ELECTRODE (K030375)Pain Management Technologies2003-05-05
BIOMET CRANIOFACIAL ACRYLIC CEMENT (K011399)Biomet, Inc.2003-05-05
ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 (K023230)Western Clinical Technology Systems, Inc.2003-05-05
POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC (K031129)C.R. Bard, Inc.2003-05-05
ADHOC CLAW (K023963)Future Medical Systems, Inc.2003-05-05
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES (K031178)Synthes (Usa)2003-05-05
GLYCA-DIRECT FRUCTOSAMINE (K023654)Polymedco, Inc.2003-05-02
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 (K030207)Shanghai Motex Healthcare Co., Ltd.2003-05-02
ACCESS OV MONITOR ASSAY (K031297)Beckman Coulter, Inc.2003-05-02
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR (K031257)Rita Medical Systems, Inc.2003-05-02
KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES (K030607)Kavo America2003-05-02
GE PROPELLER IMAGING OPTION FOR MRI (K031230)GE Medical Systems2003-05-02
REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030026)Alliance Medical Corp.2003-05-02
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION (K024289)Bausch & Lomb, Incorporated2003-05-02
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K030346)Fmd, LLC2003-05-02
FLUORILAQ (K030488)Pascal Co., Inc.2003-05-02
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION (K023286)Neptec Design Group, Ltd.2003-05-02
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) (K031062)Taiject Medical Device Co., Ltd.2003-05-02
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE (K030343)Gyrus Ent LLC2003-05-02
BRM2 BRAIN MONITOR (K030489)Brainz Instruments , Ltd.2003-05-02
AIRLIFE DEMAND NASAL CANNULA (K023673)Allegiance Healthcare Corp.2003-05-02
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS (K030515)Hans Rudolph, Inc.2003-05-02
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20 (K030347)Eizo Nanao Corporation2003-05-02
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K031226)Advanced Sterilization Products2003-05-02
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269)Beckman Coulter, Inc.2003-05-02
HIVOX DREAMATE DM-800 (K021952)Hivox Biotek, Inc.2003-05-02
CLEARBLUE EASY DIGITAL PREGNANCY TEST (K030659)Unipath , Ltd.2003-05-02
POWDERED VINYL EXAM GLOVES, WHITE (K030997)Heyuan Hongli Industries, Inc.2003-05-02
ANA DETECT (K030929)Orgentec Diagnostika GmbH2003-05-02
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 (K030349)Bonso Electronics International, Inc.2003-05-02
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR (K031223)Dideco S.P.A.2003-05-02
CHUMP (K030017)Colours 'N Motion2003-05-01
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR (K030432)Imc-Heart Way LLC2003-05-01
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES (K030733)Zimmer, Inc.2003-05-01
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM (K031162)Smith & Nephew, Inc.2003-05-01
STRATUSOCT WITH RNFL NORMATIVE DATABASE (K030433)Carl Zeiss Meditec, Inc.2003-05-01
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Every clearance here is in the API, with alerts when new ones post.