Atlas FDA

2006

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

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RecordFirmDate
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS (K062116)DePuy Orthopaedics, Inc.2006-08-18
SYNEX II (K061891)Synthes Spine Co.Lp2006-08-18
HD11 DIAGNOSTIC ULTRASOUND SYSTEM (K062247)Philips Ultrasound, Inc.2006-08-18
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA (K061736)Teleflex Medical2006-08-18
RELIEVA SINUS BALLOON CATHETER (K061903)Acclarent, Inc.2006-08-18
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA (K062168)Nemoto Kyorindo Co., Ltd.2006-08-18
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES (K061853)Grace Medical, Inc.2006-08-18
ADVANCE TOTAL KNEE SYSTEM (K061223)Wrightmedicaltechnologyinc2006-08-18
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (K060657)Breas Medical AB2006-08-18
FOLEY CATHETERS WITH TEMPERATURE PROBE (K061918)GE Healthcare2006-08-18
INTERPLATE VBR SYSTEM (K061401)Rsb Spine, LLC2006-08-18
REFLEX HYBRID ACP SYSTEM (K062310)Stryker Spine2006-08-18
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML (K061869)Becton, Dickinson & CO2006-08-18
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 (K062107)Hologic, Inc.2006-08-18
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD (K062019)Innomed Technologies, Inc./Respcare, Inc.2006-08-17
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (K061371)Cook Urological, Inc.2006-08-17
ZOLL R SERIES DEFIBRILLATOR (K060559)ZOLL Medical Corporation2006-08-17
XAMINER (K061595)Imaging Dynamics Company , Ltd.2006-08-17
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES (K061448)Bonart Co., Ltd.2006-08-17
MICROSELECTRON V3, MODEL 106.990 (K061354)Nucletron Corporation2006-08-17
DARCO LOCKING BONE PLATE SYSTEM (K061808)Darco International, Inc.2006-08-17
SIEMENS ACUSON X500 ULTRASOUND SYSTEM (K061980)Siemens Medical Solutions USA, Inc.2006-08-17
CXDI-40EC (K062221)Canon, Inc.2006-08-17
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (K060652)Gen-Probe, Inc.2006-08-17
RESPCARE HYBRID AV MASK (K062224)Respcare, Inc.2006-08-17
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM (K062248)North American Clinical Lasers, Ltd.2006-08-17
PEDI-SPIDER STRAP (K061721)Emergency Products and Research2006-08-17
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP (K062218)Jan Mao Industries Co., Ltd.2006-08-16
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K062195)Lifescan, Inc.2006-08-16
VERTEBRON SCP CERVICAL PLATE SYSTEM (K062110)Vertebron, Inc.2006-08-16
EXCEL HIGH SPEED DENTAL HANDPIECE (K061581)Orthosource, Inc.2006-08-16
TDM N-ACETYLPROCAINAMIDE (K060738)Roche Diagnostics Corp.2006-08-16
AVS PL PEEK SPACER SYSTEM (K062132)Stryker Spine2006-08-16
DMS 300-7 (K062007)Diagnostic Monitoring Software2006-08-16
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 (K062152)Dade Behring, Inc.2006-08-16
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 (K060372)Intra Lase Corp.2006-08-16
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M (K061397)Ace Surgical Supply Co., Inc.2006-08-16
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P (K060325)Horiba Abx2006-08-16
ACUBAND ACUPRESSURE WRIST BAND DEVICE (K053509)Acuband, Inc.2006-08-16
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD (K062041)Medtronic, Inc.2006-08-16
SPINAL USA VBR SYSTEM (K061752)Spinal USA2006-08-15
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 (K061361)Faxitron X-Ray Corp.2006-08-15
NAVIAID BGE DEVICE, MODEL 21-001 (K060923)Smart Medical Systems , Ltd.2006-08-15
PLAYTEX EMBRACE PETITE BREAST PUMP (K061013)Playtex Products, Inc.2006-08-15
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 (K060557)Idev Technologies, Inc.2006-08-15
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM (K061166)Biowave Corporation2006-08-15
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT (K062004)Quantum Orthopedics, Inc.2006-08-15
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS (K061953)Ge Oec Medical Systems2006-08-15
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES (K060423)Dakocytomation California, Inc.2006-08-15
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (K062259)Iscience Surgical2006-08-15
OMEGA 3 SYSTEM (K062066)Howmedica Osteonics Corp.2006-08-15
DRY LASER IMAGER, DRYPRO MODEL 832 (K061999)Konica Minolta Medical & Graphic, Inc.2006-08-15
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES (K061269)Excel Tech. , Ltd.2006-08-14
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES (K061483)Greiner Bio-One North America, Inc.2006-08-14
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS (K053505)Biomet Manufacturing, Inc.2006-08-14
REFSTAR EXTERNAL REFERENCE PATCH (K061468)Biosense Webster, Inc.2006-08-14
NELLCOR OXIMAX N-600X PULSE OXIMETER (K060576)Nellcor Puritan Bennett, Inc.2006-08-14
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS (K061610)Philips Medizin Systeme Boeblingen GmbH2006-08-14
PRESTIGE AMERITECH FACE MASK (K061716)Prestige Ameritech2006-08-14
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S (K061463)Biosense Webster, Inc.2006-08-14
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 (K061885)Dade Behring, Inc.2006-08-14
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 (K061760)K-Jump Health Co., Ltd.2006-08-14
VERTE-STACK SPINAL SYSTEM (K062073)Medtronic Sofamor Danek2006-08-14
SPIDERX EMBOLIC PROTECTION DEVICE (K062201)Ev3, Inc.2006-08-11
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707)Philips Medical Systems2006-08-11
JOSTRA HLM TUBING SETS WITH SAFELINE COATING (K061832)Maquet Cardiopulmonary, AG2006-08-11
COAGUCHEK XS SYSTEM (K060978)Roche Diagnostics2006-08-11
TRIATHLON METAL BACKED PATELLA (K061521)Howmedica Osteonics Corp.2006-08-11
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE (K061994)GE Healthcare2006-08-11
ACCU-CHEK AVIVA TEST STRIPS (K060620)Roche Diagnostics Corp.2006-08-11
ACON URINALYSIS REAGENT STRIPS (K061559)Acon Laboratories Co.2006-08-11
STRAUMANN DENTAL IMPLANTS (K061176)Institut Straumann AG2006-08-11
MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS (K061477)Nobel Biocare AB2006-08-11
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (K061332)Boston Scientific Corp2006-08-11
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM (K062220)Possis Medical, Inc.2006-08-11
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 (K061750)Dade Behring, Inc.2006-08-11
SAFETY SYRINGE (K053519)Wuxi Yushou Medical Applicances Co., Ltd.2006-08-11
NEURO II-SE, MODELS OR-MB-DR AND OR-DR (K061916)Imris, Inc.2006-08-11
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061579)Medtronic Sofamor Danek2006-08-11
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 (K061099)Hoffman Laboratories, LLC2006-08-11
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM (K061978)Ebi, L.P.2006-08-11
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451)Ascension Orthopedics, Inc.2006-08-11
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K053287)Roche Diagnostics Corp.2006-08-10
PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 (K061425)Cambridge Endoscopic Devices2006-08-10
VOLCANO S51 FAMILY OF IMAGING SYSTEMS (K061215)Volcano Corporation2006-08-10
ENZY-WELL SYPHILIS IGG, MODEL 91106 (K050590)Diesse Diagnostica Senese S.P.A.2006-08-10
VITAL CONNECT 4.0 (K062154)Vital Images, Inc.2006-08-10
NEUROQUANT (K061855)Cortechs Labs, Inc.2006-08-10
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K053289)Roche Diagnostics Corp.2006-08-10
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML (K061867)Becton, Dickinson & CO2006-08-10
DM-3000 DIGITAL BLOOD PRESSURE MONITOR (K061086)Nihon Seimitsu Sokki Co., Ltd.2006-08-10
LATERAL PLATE SYSTEM (K061789)Nuvasive, Inc.2006-08-10
EASYSPINE SYSTEM (K061017)Ldr Spine USA2006-08-10
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK (K061975)Acmi Corporation2006-08-10
BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 (K061367)Blue Sky Medical Group Incorporated2006-08-10
KNEE FUSION NAIL (K061783)Smith & Nephew, Inc.2006-08-10
LAC-MAC INNERBLOC O.R. GOWN (K061491)Lac Mac, Ltd.2006-08-09
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 (K062126)Biosphere Medical, Inc.2006-08-09
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 (K061936)The Kendall Company2006-08-09
ENHANCE DENTAL IMPLANT SYSTEM (K061335)Coastal Biocare2006-08-09
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Every clearance here is in the API, with alerts when new ones post.