Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN (K052575)St Jude Medical2006-01-19
MERIT IMPRESS DIAGNOSTIC CATHETER (K053171)Merit Medical Systems, Inc.2006-01-19
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (K042504)Myco Medical Supplies, Inc.2006-01-19
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD (K053107)Codman & Shurtleff, Inc.2006-01-19
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 (K051435)Clinical Micro Sensors2006-01-19
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS (K053350)Codman & Shurtleff, Inc.2006-01-19
SPECIMEN RETRIEVAL SYSTEM (K060051)Applied Medical Resources Corp.2006-01-19
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (K053321)Xodus Medical, Inc.2006-01-19
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K052729)Shijiazhuang Brilliant Ocean Plastic Co., Ltd.2006-01-19
SIROLASER (K053161)Sirona Dental Systems GmbH2006-01-18
GLASS CERAMICS (K053438)3M Espe AG Dental Products2006-01-18
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE (K053259)Practical Protective Plastic Manufactory , Ltd.2006-01-18
MICROSPEED UNI MOTOR SYSTEM (K053526)Aesculap, Inc.2006-01-18
OPTILENE MESH LP (K053158)Aesculap, Inc.2006-01-18
EXCELART VANTAGE ZGV (K060003)Toshibamedical Systems Corporation2006-01-18
3160 MRI PATIENT MONITORING SYSTEM (K053462)Invivo Corporation2006-01-18
CRITIVIEW (K051145)Critisense , Ltd.2006-01-18
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (K053380)Surgical Specialties Corp2006-01-18
SUPER SHEATH INTRODUCER SHEATH (K052557)Togo Medikit Co., Ltd.2006-01-17
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION (K053634)Agfa Corporation2006-01-17
SUTURING WASHER (K052642)First Call, Inc.2006-01-17
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM (K053529)Lifescan, Inc.2006-01-17
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF (K052485)Midi, Inc.2006-01-17
RM3 RENAL PRESERVATION SYSTEM (K053169)Waters Instruments, Inc.2006-01-17
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER (K051566)Proton Healthcare , Ltd.2006-01-17
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 (K052570)Cardiacassist, Inc.2006-01-17
KAPP BARI-RING, MODEL KS-BR-2005 (K050384)Kapp Surgical Instrument, Inc.2006-01-13
T-PIN (K053513)Union Surgical, LLC2006-01-13
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (K053247)Maine Standards Co.2006-01-13
DBX STRIP (K042829)Musculoskeletal Transplant Foundation2006-01-13
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES (K052976)GE Healthcare2006-01-13
FRESH, DENTAL IMPRESSION MATERIAL (K053427)Exacta Dental Products, Inc.2006-01-13
MICROSULIS TISSUE ABLATION SYSTEM (K052919)Microsulis Americas, Inc.2006-01-13
RANDOX CALIBRATION SERUM (K053153)Randox Laboratories, Ltd.2006-01-13
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, (K052710)Vident2006-01-13
IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES (K052741)W&H Dentalwerk Buermoos GmbH2006-01-13
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, (K053460)Fox Hollow Technologies2006-01-13
MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION (K052423)Siemens Medi Cal Solutions, Inc.2006-01-13
CELL-CHEX AUTO (K053362)Streck2006-01-13
CARDIOSOFT PC ECG, USB VERSION (K052295)Cardiosoft, L.P.2006-01-13
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) (K052935)Heidelberg Engineering2006-01-13
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE (K053436)Cryocath Technologies, Inc.2006-01-13
HEMOSIL PROS (K053499)Instrumentation Laboratory CO2006-01-13
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES (K053227)Medical Illumination International, Inc.2006-01-13
POWERPICC (K053501)Bard Access Systems, Inc.2006-01-13
ENDIUS ATAVI SYSTEM (K053267)Endius, Inc.2006-01-13
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge (K053110)I-Stat Corporation2006-01-13
PROFEMUR LX HIP STEM (K053588)Wrightmedicaltechnologyinc2006-01-13
SEVEN STAR NEEDLE (K052723)Helio Medical Supplies, Inc.2006-01-13
MSAS-VANTAGE (K053004)Biomeridian, Int.2006-01-13
TRACTION SYSTEM, DIGIT-TRAC 930 (K052453)Ever Prosperous Instrument, Inc.2006-01-13
ALOKA SD-3500 ULTRASOUND SYSTEM (K060059)Aloka Co., Ltd.2006-01-13
SHORT CITATION FEMORAL STEM (K053528)Stryker Orthopaedics2006-01-13
FLOWHANDY ZAN100 USB (K052176)Zan Messgerate GmbH2006-01-12
DELTA4 (K052920)Scandidos AB2006-01-12
CDMX-H (K053221)Camsight Co., Inc.2006-01-12
LOFLO C5 CO2 SENSOR (K053174)Respironics Novametrix, LLC2006-01-12
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET (K053283)Pajunk GmbH2006-01-12
ALARIS SAFETY MALE LUER (K053049)Cardinal Health, Alaris Products2006-01-12
POWDERED VINYL EXAMINATION GLOVE (K052984)Tg Medical (China) Incorporation2006-01-11
SIMPLICI-T ANNULOPLASTY SYSTEM (K052970)Medtronic Heart Valves2006-01-11
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM (K053472)Howmedica Osteonics Corp.2006-01-11
6248VAL ADJUSTABLE VALVE (K052459)Medtronic Vascular2006-01-11
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K053130)Nonin Medical, Inc.2006-01-11
TEGO, MODEL D1000 (K053106)Icu Medical, Inc.2006-01-10
EXFEEL IMPLANT SYSTEM (K052369)Megagen Co., Ltd.2006-01-10
NEWPORT E360 VENTILATOR (K053502)Newport Medical Instruments, Inc.2006-01-10
PRECISION BLENDER (K053232)Precision Medical, Inc.2006-01-10
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (K051271)Nellcor Puritan Bennett, Inc.2006-01-10
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 (K053522)Philips Medizin Systeme Boeblingen GmbH2006-01-10
CG-7000DX-BT ECG RECORDER/TRANSMITTER (K052556)Card Guard Scientific Survival , Ltd.2006-01-09
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (K053425)Precision Optics Corp.2006-01-09
PARAPOST PARACORE AUTOMIX 5ML (K052820)Coltene/Whaledent AG2006-01-09
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 (K053062)Cardiarc , Ltd.2006-01-06
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN (K052964)Boston Scientific Corp2006-01-06
THE FINGER GUARD (K052619)T F & G Products2006-01-06
RAPHAEL COLOR (K052863)Hamilton Medical AG2006-01-06
NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY (K052566)Abbott Spine, Inc.2006-01-06
CD HORIZON SPINAL SYSTEM (K053474)Medtronic Sofamor Danek2006-01-06
EKOS MICRO-INFUSION SYSTEM (K053437)Ekos Corp.2006-01-06
ESTECH COBRA ELECTROSURGICAL UNIT & CABLE (K053326)Endoscopic Technologies, Inc.2006-01-06
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS (K051031)Ameriwater2006-01-06
ALIGNRT (K052682)Vision RT Limited2006-01-06
MAYFIELD SCANMATE MOBILE CT SYSTEM (K053210)Schaerer Mayfield USA, Inc.2006-01-06
UROK ROCKING WHEELCHAIR, MODEL 700-4XX (K052548)Amg Medical, Inc.2006-01-06
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS (K053322)Roei Medical Technologies, Ltd.2006-01-06
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (K053410)Kendall2006-01-06
VERAVIEW IC 5, MODEL XDP1 (K053220)J. Morita USA, Inc.2006-01-06
NDR+/DIVA-D (K053029)Nical Spa2006-01-06
PITT-EASY DENTAL IMPLANT SYSTEM (K053242)Innova Life Sciences Corp.2006-01-06
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT (K053445)DePuy Orthopaedics, Inc.2006-01-06
5TH METATARSAL FRACTURE SCREW (K053136)Wrightmedicaltechnologyinc2006-01-05
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR (K051847)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-01-05
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM (K053209)Suntech Medical, Inc.2006-01-05
CHROMOLITE SYSTEM (K053324)Chromogenex Plc2006-01-05
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K053483)Medtronic Sofamor Danek2006-01-05
MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM (K053285)Durtech System Corp.2006-01-05
CD HORIZON SPINAL SYSTEM (K053101)Medtronic Sofamor Danek2006-01-05
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT (K053299)Biomet Manufacturing, Inc.2006-01-05
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES (K053272)Cardinalhealth2006-01-05
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Every clearance here is in the API, with alerts when new ones post.