Atlas FDA

2006

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

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RecordFirmDate
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) (K042850)Stereotaxis, Inc.2006-08-09
TENOLIG (K060367)Fournitures Hospitalieres Industrie2006-08-09
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER (K061179)C.R. Bard, Inc.2006-08-09
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) (K062008)Niti Medical Technologies , Ltd.2006-08-09
VERTE-STACK SPINAL SYSTEM (K061938)Medtronic Sofamor Danek, Inc.2006-08-09
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060318)Horiba Abx2006-08-08
COMCASET SAFETY IV CATHETER (K062108)Pitango Medical, Ltd.2006-08-08
COMPUDENT STA (K061904)Milestone Scientific, Inc.2006-08-08
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (K061107)Thermo Electron OY2006-08-08
ORBITAL TISSUE EXPANDER (OTE) (K060151)Innovia, LLC2006-08-08
ONLINE VALPROIC ACID (K060690)Roche Diagnostics Corp.2006-08-08
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS (K061500)Sic Invent AG2006-08-08
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION (K062091)Porous Media Corp.2006-08-08
XCAT; XCAT FOR NEURO (K061834)Xoran Technologies, Inc.2006-08-07
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 (K060355)Acro Biotech, LLC2006-08-07
PARAGOLFER (K060936)Parabasetec, GmbH2006-08-07
TREP-SURE TREPONEMAL ANTIBODY EIA (K053570)Phoenix Biotech Corp.2006-08-07
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793)Dade Behring, Inc.2006-08-07
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM (K061755)Esaote Europe B.V.2006-08-07
MEDCHANNEL HTS SYSTEM (K061831)Medchannel, LLC2006-08-07
CO-1000 COLPOSCOPE, MULTIPLE (K061306)Gynex Corp.2006-08-07
MONOCHROME LCD MONITOR, RADIFORCE, GS320 (K062053)Eizo Nanao Corporation2006-08-07
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS (K061801)Arthrotek, Inc.2006-08-07
COUGAR WHEELCHAIR (K061810)R82 A/S2006-08-07
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE (K061404)Fci Ophthalmics, Inc.2006-08-07
GORE PRECLUDE VESSEL GUARD (K061727)W. L. Gore & Associates, Inc.2006-08-07
RAPIDONE-BUPRENORPHINE TEST (K060760)American Bio Medica Corp.2006-08-07
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH (K062055)Dade Behring, Inc.2006-08-07
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (K060810)Ind Diagnostic, Inc.2006-08-07
SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)Synthes (Usa)2006-08-04
PRODRIVE SYSTEMS REPLACEMENT TURBINE (K062219)Prodrive Systems, Inc.2006-08-04
NAUTIFLUX (K060010)Sedat2006-08-04
SONIX ULTRASOUND SCANNER (K061827)Ultrasonix Medical Corporation2006-08-04
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS (K061955)Creative Medical Designs, Inc.2006-08-04
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE (K061779)Smith & Nephew, Inc.2006-08-04
ENDO-EASE ENDOSCOPIC OVERTUBE (K060235)Spirus Medical, Inc.2006-08-04
BEST STRAND AND BEST SPACER (K061638)Best Medical International, Inc.2006-08-04
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) (K060972)Kendall2006-08-04
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY (K061589)Solarc Systems, Inc.2006-08-04
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS (K061450)Hospira, Inc.2006-08-04
12 RL ALGORITHM (K060307)Ge Medical Systems Information Technologies2006-08-04
MARATHON STENT WITH FUSION TECHNOLOGY (K060624)Cook Ireland, Ltd.2006-08-04
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 (K061730)Osmetech, Inc.2006-08-04
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 (K061963)Micrus Endovascular Corporation2006-08-04
VERSALET 7700 CARE CENTER (K053399)Draeger Medical Infant Care, Inc.2006-08-04
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION (K053348)Howmedica Osteonics Corp.2006-08-04
LISFRANC PLATE (K060474)New Deal, S.A.2006-08-03
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE (K061492)Tyco Healthcare2006-08-03
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 (K061986)Medcomp2006-08-03
TRIATHLON LOW PROFILE TIBIAL TRAY (K062037)Howmedica Osteonics Corp.2006-08-03
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS (K061383)B.T.I. Biotechnology Institute, Sl.2006-08-03
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER (K061015)St Jude Medical2006-08-03
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 (K061165)Sweden Diagnostics (Us), Inc.2006-08-03
AVS ASL PEEK SPACER SYSTEM (K061836)Stryker Spine2006-08-03
VECTORS TEMPORARY ANCHORAGE SYSTEM (K061230)Sybron Dental Specialties2006-08-03
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET (K061344)Aesculap, Inc.2006-08-02
BLOXX RAPID CLOTTING AGENT (K061722)Crosslink-D, Inc.2006-08-02
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) (K061703)Dade Behring, Inc.2006-08-02
MED SCULPT (K053041)General Project S.R.L.2006-08-02
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE (K061226)Zimmer, Inc.2006-08-02
AGCEL WOUND DRESSING,AGCEL BURN DRESSING (K050842)Modern Medical Equipment Mfg., Ltd.2006-08-02
VISION VXC CENTRAL STATION, MODEL 4300 (K061675)Invivo Corporation2006-08-02
PEPER (K060297)Medical Monitors, Ltd.2006-08-02
SMARTMONITOR 2PS (K061256)Respironics, Inc.2006-08-02
U-CLIP DEVICE, MODEL NC65 (K062057)Medtronic Vascular2006-08-02
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 (K061822)Omron Healthcare, Inc.2006-08-02
LANGSTON DUAL LUMEN CATHETER (K061565)Vascular Solutions, Inc.2006-08-02
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 (K061373)Vnus Medical Technologies, Inc.2006-08-01
MEDCOMP VASCU-SHEATH II (K053092)Medcomp2006-08-01
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM (K061392)Ikonisys, Inc.2006-08-01
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR (K061857)Bio Compression Systems, Inc.2006-08-01
VENTURE WIRE CONTROL CATHETER, MODEL WCC (K061843)St Jude Medical2006-08-01
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) (K061486)Procter & Gamble Co.2006-08-01
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM (K061522)Activatek, Inc.2006-08-01
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N (K061762)Cardinal Health, Inc.2006-08-01
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES (K061882)Zimmer, Inc.2006-08-01
12SL ECG ANALYSIS PROGRAM (K060833)Ge Medical Systems Information Technologies2006-08-01
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET (K061513)Smiths Medical Asd, Inc.2006-08-01
FUSION (K061912)Burke, Inc.2006-08-01
DORNIER MEDILAS H 20 LASER (K061455)Dornier Medtech America, Inc.2006-08-01
G-LIX TISSUE GRASPER (K061268)Usgi Medical2006-07-31
FLEXVIEW SYSTEM (K062050)Boston Scientific2006-07-31
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR (K061266)Ortho Organizers, Inc.2006-07-31
NC-STAT (K060584)Neurometrix, Inc.2006-07-31
DIASORIN LIAISON TREPONEMA ASSAY (K061247)DiaSorin, Inc.2006-07-31
SURPASS (K061981)Apex Dental Materials, Inc.2006-07-31
BRIGIT SURGICAL DEVICE (K060556)Zimmer, Inc.2006-07-31
INTUITION INFUSION SETS (K061374)Unomedical A/S2006-07-31
NXSTAGE CARTRIDGE EXPRESS (K061837)Nxstage Medical, Inc.2006-07-31
SPI ART ABUTMENTS (K061807)Thommen Medical AG2006-07-31
ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE (K053654)Atlantis Components, Inc.2006-07-31
LMT NOMAG IC 3.0 (K062052)Lmt Lammers Medical Technology GmbH2006-07-31
COOLTOUCH VARIA ND:YAG LASER SYSTEM (K060966)Cooltouch, Inc.2006-07-31
CELSITE/ CELSITE CONCEPT, ACCESS PORTS (K061424)Aesculap, Inc.2006-07-31
STA - CONTROL LA 1+2 (K061803)Diagnostica Stago, Inc.2006-07-28
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE (K062024)Dade Behring, Inc.2006-07-28
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 (K061952)Invivo2006-07-28
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561)Hologic, Inc.2006-07-28
BIOLUCENT APPLICATOR, MODEL RTA-XX (K061241)Biolucent, Inc.2006-07-28
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML (K061673)Becton, Dickinson & CO2006-07-28
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Every clearance here is in the API, with alerts when new ones post.