Atlas FDA

2003

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

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RecordFirmDate
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER (K031488)Cynosure, Inc.2003-06-04
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT (K030700)Biolitec, Inc.2003-06-04
3-CCD DIGITAL CAMERA SYSTEM (K031098)Linvatec Corp.2003-06-04
BIO-MODULAR SHOULDER SYSTEM (K030710)Biomet, Inc.2003-06-04
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC (K023691)Boston Scientific Epi2003-06-04
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112 (K030824)Hakko Medical Co., Ltd.2003-06-04
PALOMAR LIGHTCUBE (K024179)Palomar Medical Products, Inc.2003-06-04
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) (K031303)Aesculap, Inc.2003-06-04
ARTERIALFLOW SYSTEM, MODEL 32A (K024019)Aircast, Inc.2003-06-03
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH (K030684)Acmi Corporation2003-06-03
PNEUTON VENTILATOR (K024344)Airon Corporation2003-06-03
SIEMENS MICRO2+ WITH VAI SOFTWARE (K030640)Siemens Medical Solutions USA, Inc.2003-06-03
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 (K031000)C.R. Bard, Inc.2003-06-03
MAGLIFE C/MAGLIFE C PLUS (K023195)Schiller Medical S.A.2003-06-03
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM (K030724)Zimmer, Inc.2003-06-03
NANMA VACUUM PUMP (K030913)Nanma Mfg Co., Ltd.2003-06-03
7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS (K030822)Hans Rudolph, Inc.2003-06-03
ULTRABLATOR ELECTRODE (K030720)Linvatec Corp.2003-06-03
SHANCHUAN SYRINGE (K021993)Shangdong Zibo Shanchuan Medical Instruments Co.2003-06-03
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (K030848)Karl Storz Endoscopy2003-06-02
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) (K031135)Dade Behring, Inc.2003-06-02
CRP (II) CALIBRATORS (K030546)Denka Seiken Co., Ltd.2003-06-02
CRP-LATEX (II)X2 SEIKEN ASSAY KIT (K030545)Denka Seiken Co., Ltd.2003-06-02
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY (K031506)Beckman Coulter, Inc.2003-06-02
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE (K031306)Becton, Dickinson & CO2003-06-02
STRYKER NAVIGATION SYSTEM-KNEE MODULE (K022579)Stryker Leibinger2003-06-02
SPECTRUM SILICONE CATHETER (K021557)Cook, Inc.2003-05-30
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) (K030839)Medtronic Ave, Inc.2003-05-30
GRANDIO (K030915)Voco GmbH2003-05-30
STARCAST DENTAL ALLOYS (K031543)Star Refining Precious Metals South Africa2003-05-30
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP (K030587)S-Tct Health, Inc.2003-05-30
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (K031364)Medical Analysis Systems, Inc.2003-05-30
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND (K030813)Primary Care Solutions, Inc.2003-05-30
VAPOTHERM 2000H (K013486)Vapotherm, Inc.2003-05-30
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 (K031403)Philips Medical Systems, Inc.2003-05-30
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC (K030593)X-Cel Contacts, A Walman Co.2003-05-30
MSI SA ELECTRODES (K030996)Medsphere International, Inc.2003-05-30
CAREO RETRACTABLE SAFETY SYRINGE (K030976)Life-Shield Products, Inc.2003-05-30
STRYKER PAINPUMP2 (K030661)Stryker Instruments2003-05-30
FRESENIUS ULTRAFLUX HEMODIALYZER (K031378)Fresenius Medical Care North America2003-05-30
SYS*STIM 208 AND 208A (K031017)Mettler Electronics Corp.2003-05-30
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) (K030972)Disc-O-Tech Medical Technologies, Ltd.2003-05-30
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM (K023887)Inion , Ltd.2003-05-30
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS (K031552)Medison America, Inc.2003-05-30
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (K031279)Terumo Medical Products Hangzhou Co., Ltd.2003-05-30
EXOJET TISSUE MANAGEMENT SYSTEM (K031406)Mitek Worldwide2003-05-30
REBILDA DC (K030914)Voco GmbH2003-05-30
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM (K031508)Synthes (Usa)2003-05-30
SURSHIELD SAFETY WINGED INFUSION SET (K031266)Terumo Corp.2003-05-30
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING (K030726)Gish Biomedical, Inc.2003-05-30
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS (K031362)Lac Mac, Ltd.2003-05-30
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB (K030781)Eastman Kodak Company2003-05-29
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 (K031011)Valleylab, Inc.2003-05-29
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (K030699)J. Morita Mfg. Corp.2003-05-29
ALPHA 5000 WRIST COIL (K031143)Usa Instruments, Inc.2003-05-29
CARECOMPANION PATIENT STATION & NURSE STATION (K022274)Neptec Design Group, Ltd.2003-05-29
PACEART SYSTEM (K024278)Medtronic Vascular2003-05-29
TOKUYAMA SOFRELINER TOUGH (K030663)Tokuyama Dental Corporation2003-05-29
IPACS PRISM (K030751)Realtimeimage, Inc.2003-05-29
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 (K031481)Philips Medizin Systeme Boblingen GmbH2003-05-29
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K031286)Aesculap, Inc.2003-05-29
SPIRIT III TOTALSENSE CARDIAC COIL (K031172)Usa Instruments, Inc.2003-05-29
PREMIER III PHASED ARRAY CTL SPINE COIL (K031139)Usa Instruments, Inc.2003-05-29
WATER PURIFICATION SYSTEM (K022448)Purity Water Company of San Antonio, Inc.2003-05-28
IN-VISION IMAGING SYSTEM (K031148)Jomed, Inc.2003-05-28
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) (K031219)Orthofix, Inc.2003-05-28
PAPILLON MASK SET (K023068)Map Medizintechnik Fur Arzt Und Patient GmbH2003-05-28
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (K023662)Hwadong International Company , Ltd.2003-05-28
ENCORE ANTERIOR SPINAL STAPLE SYSTEM (K030667)Encore Medical L.P.2003-05-28
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (K023937)Cook Vascular, Inc.2003-05-27
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE (K030618)Wilson-Cook Medical, Inc.2003-05-27
APTUS BLUE (K030884)Acadental2003-05-27
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM (K031610)Rex Medical2003-05-27
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT (K012889)Pascal Co., Inc.2003-05-27
GENESIS II TOTAL KNEE SYSTEM (K030612)Smith & Nephew, Inc.2003-05-27
FYRELINK VL (K030728)Mpacs, LLC2003-05-23
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 (K030827)Orthosoft, Inc.2003-05-23
AMSURE URETHRAL CATHETERIZATION TRAY (K030712)Amsino International, Inc.2003-05-23
DEFLECTING URETERAL ACCESS SHEATH (K030642)Applied Medical Resources Corp.2003-05-23
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H (K030592)Gambro Renal Care Products2003-05-23
ULTRAEKOGEL MODELS EK 2000 & EK 2001 (K030889)Inmed Ltda.2003-05-23
AMSURE FOLEY INSERTION TRAY (K030664)Amsino International, Inc.2003-05-23
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K031120)Synmertex Co, Ltd.2003-05-23
MODIFICATION TO TRUPEAK PEAK FLOW METER (K031514)Monaghan Medical Corp.2003-05-23
SAPHYRE BIPOLAR ABLATION PROBES (K031371)Smith & Nephew, Inc.2003-05-23
GE 1.5T 8 CHANNEL TORSO COIL (K031209)Ge Medical Systems, Inc.2003-05-23
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398)Cardiacassist, Inc.2003-05-23
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (K030930)Nellcor Puritan Bennett, Inc.2003-05-23
GMRS PRESS FIT STEMS WITH PUREFIX HA (K031217)Howmedica Osteonics2003-05-23
PATHWAY STM-10 PELVIC FLOOR STIMULATOR (K030039)The Prometheus Group2003-05-23
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE (K031344)Ranfac, Corp.2003-05-23
NAVIGATOR URETERAL ACCESS SHEATH SET (K030956)Boston Scientific Corp2003-05-23
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP (K031361)Deltec, Inc.2003-05-23
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) (K030230)Avita Corporation2003-05-23
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM (K031117)Galil Medical , Ltd.2003-05-23
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K031076)Synmertex Co, Ltd.2003-05-23
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES (K031171)Synmertex Co, Ltd.2003-05-23
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 (K031262)Ndo Surgical, Inc.2003-05-23
APEX MODULAR ACETABULAR CUP (K031110)Apex Surgical, LLC2003-05-22
'RAPID ONE' - PROPOXYPHENE TEST (K030835)American Bio Medica Corp.2003-05-22
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Every clearance here is in the API, with alerts when new ones post.