Atlas FDA

2003

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

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RecordFirmDate
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 (K030338)Curelight, Ltd.2003-02-12
WIENER LAB. BILIRUBINA DIRECT AA (K024116)Wiener Laboratories Saic2003-02-12
FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (K023825)S.A.I.E.P. S.R.L.2003-02-12
WELCH ALLYN VITAL SIGN MONITOR WITH MP506 (K024005)Welch Allyn, Inc.2003-02-12
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT (K024164)Metro Optics, Inc.2003-02-12
STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE (K030106)Medtronic Surgical Navigation Technologies2003-02-12
WIENER LAB COLINESTERASA AA (K023992)Wiener Laboratories Saic2003-02-12
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K021962)The Olympus Optical Co.2003-02-12
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM (K024147)Varian Medical Systems, Inc.2003-02-12
ENHANCE-S PLUS H (K030116)Conception Technology, Inc.2003-02-12
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (K021193)Fortune Medical Instrument Corp.2003-02-12
TISSUELINK BIPOLAR FLOATING BALL DEVICE (K022532)Tissuelink Medical, Inc.2003-02-12
FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (K023801)S.A.I.E.P. S.R.L.2003-02-12
SLEEPSCREEN/APNOESCREEN CARDIO (K021138)Erich Jaeger GmbH2003-02-12
MINOLTA PULSOX-2 (K021469)Konica Minolta Sensing, Inc.2003-02-12
HEMOSIL FACTOR VII DEFICIENT PLASMA (K024082)Instrumentation Laboratory CO2003-02-12
A16 BLOOD FLOW MEASUREMENT SYSTEM (K023707)D. E. Hokanson, Inc.2003-02-12
SIEMENS INFINITY SC 6002XL MODIFICATIONS (K030313)Siemens Medical Solutions USA, Inc.2003-02-11
MEDSTAR SYSTEM, MODELS 533-300 (K020534)Cybernet Medical2003-02-11
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM (K030199)General Electric Co.2003-02-11
CLEARFIL SE BOND PLUS (K023842)Kuraray Medical, Inc.2003-02-11
TWLIGHT, MODEL ISP 9600 (K022642)Invacare Corp.2003-02-11
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES (K023915)Sanrea Healthcare Private Limited2003-02-11
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES (K021852)Olympus Optical Co., Ltd.2003-02-11
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE (K023401)Pentax Precision Instrument Corp.2003-02-11
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K023248)Orbus Medical Technologies2003-02-11
WAKO NEFA LINEARITY SET (K030065)Wako Chemicals USA, Inc.2003-02-11
STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES (K023910)Sanrea Healthcare Private Limited2003-02-11
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM (K022747)Hydropure Systems, Inc.2003-02-11
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (K023805)Laerdal Medical A/S2003-02-11
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (K023944)Bayer Corp.2003-02-11
TRILAMINATE DRAPES/TIBURON (K023419)Allegiance Healthcare Corp.2003-02-11
MARK I THERMAL IMAGER (K023925)Ix-Dr, Inc.2003-02-11
TECHNOS MP, MODEL AU6 (K023255)Biosound Esaote, Inc.2003-02-11
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR (K023793)Portex, Inc.2003-02-11
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM (K023912)Sanrea Healthcare Private Limited2003-02-11
ACON STREP A TWIST TEST DEVICE (K023766)Acon Laboratories Co.2003-02-10
POLARIS DS (K024064)Syneron Medical, Ltd.2003-02-10
THOR DDII 830CL3 LASER SYSTEM (K030226)Thor Intl.2003-02-10
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 (K023800)Aircast, Inc.2003-02-10
DRI PRIMIDONE CALIBRATORS (K023780)Microgenics Corp.2003-02-10
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (K022856)Aaron Medical Industries2003-02-10
LUNG NODULE ASSESSMENT AND COMPARISON OPTION (K023785)Philips Medical Systems (Cleveland), Inc.2003-02-10
ALLON 2001 VERSION 5 (K024128)Mtre Advanced Technology , Ltd.2003-02-10
NOBEL PERFECT IMPLANT SYSTEM (K030257)Nobel Biocare Uas, Inc.2003-02-10
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 (K021153)Goldway Us, Inc.2003-02-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML (K024153)Becton, Dickinson & CO2003-02-10
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 (K022696)Teh Lin Prosthetic & Orthopaedic, Inc.2003-02-07
SOHNIKS (K023783)Sohniks Endoscopy, Inc.2003-02-07
NELLCOR INDGO MANUAL RESUSCITATOR (K023494)Nellcor Puritan Bennett, Inc.2003-02-07
DIAMONDCOAT ULTRASONIC INSERTS (K030111)Dentsply International2003-02-07
SILICONE DUAL LUMEN RADPICC CATHETERS (K030255)C.R. Bard, Inc.2003-02-07
PREPARE CARTRIDGE (K023890)Appro Healthcare, Inc.2003-02-07
AUTOMED 3000 INFUSION PUMP (K023863)Help Technologies2003-02-07
W & H LISA STEAM STERILIZER (K022816)A-Dec, Inc.2003-02-07
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194)Lifescan, Inc.2003-02-07
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 (K023868)Dannoritzer Medical Instruments2003-02-07
BD INTEGRA SYRINGE (K023752)Bd2003-02-07
NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6 (K030126)Norm Pacific Automation Corp.2003-02-07
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (K024151)Theratest Laboratories, Inc.2003-02-06
BIOARC SP SLING KIT (K030123)American Medical Systems, Inc.2003-02-06
KOMPRESSOR SCREW SYSTEM (K024233)Kinetikos Medical, Inc.2003-02-06
SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (K023593)Quest Intl., Inc.2003-02-06
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 (K021271)Biomedical Life Systems2003-02-06
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 (K021270)Biomedical Life Systems2003-02-06
OLYMPUS FERRITIN REAGENT (K030124)Olympus America, Inc.2003-02-06
SYNAMPS2 (K023771)Neuroscan2003-02-06
STEP-SAVER STAIRWAY CHAIRLIFT (K024167)Services Industriels Savaria, Inc.2003-02-06
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (K024031)Theratest Laboratories, Inc.2003-02-06
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P (K024046)Bisco, Inc.2003-02-06
SONOCALC (K030223)Sonometric Health, LLC2003-02-06
FASSIRE-DUVAL TELESCOPIC IM SYSTEM (K020885)Pega Medical, Inc.2003-02-06
CARDIUS-1 AND CARDIS-2 (K030085)Digirad Corp.2003-02-05
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (K030103)Depuyacromed2003-02-05
SPINEMED (K030060)Cert Health Sciences, LLC2003-02-05
HA PMI FEMORAL HIP STEM (K030048)Biomet Orthopedics, Inc.2003-02-05
REPROCESSED COMPRESSION SLEEVE (K021654)Alliance Medical, Inc.2003-02-05
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 (K022959)MDC Research , Ltd.2003-02-05
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ (K023994)Ortho Tec, LLC2003-02-05
NESS CHILDREN SYSTEM (K024279)Ness-Neuromuscular Electrical Stimulation Systems2003-02-05
OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM (K022877)Vision Chips, Inc.2003-02-05
SMALL TITANIUM WRIST FUSION PLATE (K023879)Synthes (Usa)2003-02-05
UNIVERSAL TOTAL WRIST SYSTEM (K030037)Kinetikos Medical, Inc.2003-02-05
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS (K030079)Zimmer, Inc.2003-02-05
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM (K030122)DePuy Orthopaedics, Inc.2003-02-05
FRIOS ALGIPORE (K023799)Friadent GmbH2003-02-05
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K023946)ACON Laboratories, Inc.2003-02-05
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT (K024003)Gelflex2003-02-05
JET-X HA COATED HALF PINS (K023921)Smith & Nephew, Inc.2003-02-05
SPIRIT III TOTALSENSE CARDIAC COIL (K024187)Usa Instruments, Inc.2003-02-04
GE DISCOVERY LS SYSTEM (K023988)GE Medical Systems2003-02-04
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR (K023828)Kamiya Biomedical Co.2003-02-04
AIROCIDE TI02 (K023830)Kes Science & Technology, Inc.2003-02-04
PANORAMA ENHANCEMENTS (K024042)Philips Medical Systems, Inc.2003-02-04
UP-DF500 FILMSTATION DIGITAL FILM IMAGER (K024188)Sony Medical Systems2003-02-04
TRUTEK SELECT MODEL TT-1001 (K023510)Trutek, Inc.2003-02-04
HTS COIL (K022863)Jockey Club Mri Engineering Center2003-02-04
INFINION SOFTWARE FEATURES (K024066)Philips Medical Systems (Cleveland), Inc.2003-02-04
SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (K023540)Valumed2003-02-04
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 (K014001)Oral Osteodistraction, L.P.2003-02-04
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