Atlas FDA

2006

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

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RecordFirmDate
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML (K060444)Becton, Dickinson & CO2006-04-12
NEUROPROBES (K052527)Alpha Omega Engineering , Ltd.2006-04-12
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER (K060327)Vascular Solutions, Inc.2006-04-12
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER (K060960)Boston Scientific Corporation2006-04-12
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168FV (K060729)Health & Life Co., Ltd.2006-04-12
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE (K060782)Smith & Nephew Wound Management2006-04-12
IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K060695)Ion Beam Applications S.A.2006-04-11
ATRILAZE SURGICAL ABLATION SYSTEM (K060680)Medical Cv, Inc.2006-04-11
VUMAX (K060626)Sonomed, Inc.2006-04-11
EPICERAM (K052643)Ceragenix Corporation2006-04-11
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (K053520)Tripath Imaging, Inc.2006-04-11
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM (K060522)Scandius Biomedical, Inc.2006-04-11
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (K060302)Cordis Europa, N.V.2006-04-11
HDR 1000 PLUS WELL CHAMBER, MODEL 90008 (K060532)Standard Imaging, Inc.2006-04-11
TRAVEL PAL (MM-111B) /MEGA MOTION (K060697)Mega Motion, Inc.2006-04-11
ARTHROCARE WANDS (K060823)Arthrocare Corp.2006-04-10
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 (K052322)C.R. Bard, Inc.2006-04-10
IN-OVATION C (K060837)Dentsply International2006-04-10
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS (K050826)Cetro America2006-04-10
EZ-OX PLUS (K053117)Air Liquide Healthcare America2006-04-10
MICROPOWER HAND PIECE HIGH SPEED DRILL (K060260)Linvatec Corp.2006-04-10
TOTAL KNEE SURGETICS NAVIGATION SYSTEM (K060282)Praxim S.A2006-04-10
ECHOHEART TRANSVAGINAL DOPPLER PROBE (K060410)Summit Doppler Systems, Inc.2006-04-10
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 (K051984)Boston Scientific Corp2006-04-10
STETHOFLUX (K060064)Odvi2006-04-10
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 (K060391)Intuitive Surgical, Inc.2006-04-10
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK (K060755)Roche Diagnostics Corp.2006-04-10
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (K060270)Linvatec Corp.2006-04-10
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 (K060193)Oceanic Medical Products, Inc.2006-04-10
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE (K053441)Regent Medical Americas, LLC2006-04-10
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) (K060658)Brightway Holdings Sdn. Bhd.2006-04-10
SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM (K053542)Praxim S.A2006-04-10
THE AMO OPHTHALMIC SURGICAL SYSTEM (K060366)Advanced Medical Optics, Inc.2006-04-07
SEEKER/SPARK ULTRASOUND SYSTEM (K060800)Ardent Sound, Inc.2006-04-07
SVIEW (K060840)Mri Cardiac Services, Incorporated2006-04-07
VPAP III ST-A/KIDSTA MASK SYSTEM (K060105)Resmed, Ltd.2006-04-07
GELPORT BLUNT TIP TROCAR SYSTEM (K060629)Applied Medical Resources Corp.2006-04-07
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (K060315)Healthstats International Pte. , Ltd.2006-04-07
MACTRODE 3 (K060661)Ge Medical Systems Information Technologies2006-04-07
VECTRA LASER SYSTEM (K060114)Xintec Corporation, Dba,2006-04-07
SEE-IT CARIES DETECTOR (K060330)Ronvig Dental Mfg. A/S2006-04-07
VISUM LED SURGICAL LIGHTING SYSTEM (K060802)Stryker Communications Corp.2006-04-07
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM (K051798)Osteomed LP2006-04-07
HARMONIC SCALPEL BLADES AND SHEARS (K060245)Ethicon Endo-Surgery, Inc.2006-04-07
VALPLAST YAMAHACHI TEETH (K060507)Valplast Intl. Corp.2006-04-07
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 (K051227)Renu Medical, Inc.2006-04-07
HUMAPEN MEMOIR (K053563)Eli Lilly and Company2006-04-07
AESCULAP CRANIOFACIAL PLATE AND SCREW (K060492)Aesculap, Inc.2006-04-07
NAKED (K060797)Veraxis Int'L, Inc.2006-04-07
LIGHTSHEER DUET LASER SYSTEM (K053628)Lumenis, Inc.2006-04-07
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR (K060628)Dade Behring, Inc.2006-04-06
TECHLAB ASCA-CHEK (K051927)Techlab, Inc.2006-04-06
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (K050988)Lin-Zhi International, Inc.2006-04-06
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES (K053413)Terumo Europe N.V.2006-04-06
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR (K060714)Conmed Linvatec2006-04-06
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK (K060548)Dade Behring, Inc.2006-04-06
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (K060385)Dade Behring, Inc.2006-04-06
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 (K060650)Ortho-Clinical Diagnostics, Inc.2006-04-06
ROTATING GAMMA SYSTEM. GAMMA ART-6000 (K060314)American Radiosurgery, Inc.2006-04-06
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (K060309)Arrow Intl., Inc.2006-04-06
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS (K060638)Zimmer Spine, Inc.2006-04-06
AWQ-104 (K050989)Lhasa Oms, Inc.2006-04-06
TONOMETER DIATON (K060780)Ryazan State Instruments2006-04-06
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM (K052420)Gynova, LLC2006-04-06
ACUTE CARE FACE MASK, MODEL RT040 (K060044)Fisher & Paykel Healthcare, Ltd.2006-04-06
TREK S NEBULIZER COMPRESSOR (K060357)Pari Innovative Manufacturers, Inc.2006-04-05
ENDOSSEOUS DENTAL IMPLANT SYSTEM (K053478)Northern Implants, LLC2006-04-05
TRAM MODULE (K053121)GE Healthcare2006-04-05
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M (K053407)Analytical Industries, Inc.2006-04-05
MINXRAY, MODELS HFP24 AND HFP40 (K060566)Mikasa X-Ray Co., Ltd.2006-04-05
LASERTX - DIODE LASER & DELIVERY SYSTEM (K060326)Prosurg, Inc.2006-04-05
VYGON LEADER-FLEX (K052564)Vygon Corp.2006-04-05
ADVANCE VESSEL ANALYSIS II (K060779)GE Healthcare2006-04-05
SWIRLGRAFT VASCULAR ACCESS GRAFT (K060741)Veryan Medical Limited2006-04-05
PTS PANELS HDL CHOLESTEROL TEST STRIPS (K060617)Polymer Technology Systems, Inc.2006-04-05
XPERCT (K060749)Philips Medical Systems North America Co.2006-04-04
NOVABONE POROUS-BONE GRAFT SCAFFOLD (K060432)Novabone Products, LLC2006-04-04
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (K051438)Alliance Medical, Inc.2006-04-04
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 (K052319)Impedimed Pty , Ltd.2006-04-04
DICK'S FORMALWEAR MALE LATEX CONDOM (K050913)Dick'S Formalwear, Inc.2006-04-04
MODIFICATION TO INFINITY EXPLORER (K060254)Draeger Medical Systems, Inc.2006-04-04
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K (K060342)Rossmax International , Ltd.2006-04-04
SUPER SHEATH XL INTRODUCER SHEATH (K060190)Togo Medikit Co., Ltd.2006-04-04
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H (K060655)Biotronik, Inc.2006-04-04
PMP4 BP PRO BLOOD PRESSURE MONITOR (K060703)Card Guard Scientific Survival , Ltd.2006-04-04
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION (K053388)Puritan Bennett Corp.2006-04-04
ARTHREX ARTHOERESIS IMPLANT (K053543)Arthrex, Inc.2006-04-03
DOSE VERIFICATION SYSTEM (K052118)Sicel Technologies, Inc.2006-04-03
INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS (K060014)Intelifuse, Inc.2006-04-03
SINMED POSITIONING DEVICES (K060737)Sinmed BV2006-03-31
SIROENDO (K052515)Sirona Dental Systems GmbH2006-03-31
OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL (K053583)Optivia Medical, LLC2006-03-31
KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (K060550)Eastman Kodak Company2006-03-31
ATRIUM MEDICAL CORPORATION C-QUR MESH (K050311)Atrium Medical Corp.2006-03-31
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL (K060689)Resonance Innovations, LLC2006-03-31
NXSTAGE DIALYSATE PREPARATION MODULE (K060296)Nxstage Medical, Inc.2006-03-31
ONE STICK Y EXTENSION SET AND VOLUMETER (K060672)One Stick, LLC2006-03-31
AGILITY LP TOTAL ANKLE PROSTHESIS (K053569)DePuy Orthopaedics, Inc.2006-03-31
MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE (K060236)Iomed, Inc.2006-03-31
MAXILIM (K052424)Medicim NV2006-03-31
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