Atlas FDA

2006

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

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RecordFirmDate
AMBU WHITE SENSOR CFM, CFL (K052944)Ambu A/S2006-10-25
MALIBU SPINAL SYSTEM (K061342)Seaspine, Inc.2006-10-25
AMBU BLUE SENSOR NEO AND NEO X (K053550)Ambu A/S2006-10-25
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 (K061416)Medtronic Vascular2006-10-25
CD HORIZON SPINAL SYSTEM (K060615)Medtronic Sofamor Danek2006-10-25
PROFYLE SYSTEM (K062498)Howmedica Osteonics Corp.2006-10-25
UNICEM (K062292)3M Espe Dental Products2006-10-25
TOMAS PIN 6 MM (K062732)Dentaurum2006-10-25
DARCO FORCE TITANIUM COMPRESSION SCREW (K062103)Darco International, Inc.2006-10-25
TELEVISIT (K062338)PHD Medical2006-10-25
C. ALBICANS PNA FISH (K062461)Advandx, Inc.2006-10-25
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265)Remcore, Inc.2006-10-25
MODIFICATION TO STRYKER SPINE OASYS SYSTEM (K062853)Stryker Spine2006-10-24
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K062665)Inovel, LLC2006-10-24
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES (K062672)Grace Medical, Inc.2006-10-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML (K062687)Becton, Dickinson & CO2006-10-24
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC (K061878)E Surgical, LLC2006-10-24
KOZY COMFORT INFANT POSITIONER (K062143)Alfred E Mann Inst. For Biomedical Engineering2006-10-24
CATALYSY (K062660)Ki Mobility, LLC2006-10-24
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS (K060971)Omi Manufacturing Pty., Ltd.2006-10-24
MICROENDOSCOPE (K063078)Acclarent, Inc.2006-10-24
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER (K062148)DePuy Orthopaedics, Inc.2006-10-24
THERMACLEAR (K060653)Dermacare, Inc.2006-10-24
MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 (K062888)Emg Technology Co., Ltd.2006-10-24
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH (K062446)Terumo Medical Corp.2006-10-23
BARD COMPOSITE L/P MESH (K061754)Davol Inc., Sub. C. R. Bard, Inc.2006-10-23
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (K062850)United States Surgical, A Division of Tyco Healthc2006-10-23
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE (K060414)Kmi Kolster Methods, Inc.2006-10-23
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 (K062916)Cliniqa Corporation2006-10-23
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K061188)Foxhollow Technologies, Inc.2006-10-23
INNOVACON HCG UKTRA TEST DEVICE (K062361)Innovacon, Inc.2006-10-23
D-SPECT CARDIAC SCANNER SYSTEM (K062450)Spectrum Dynamics , Ltd.2006-10-20
P.0004 IMPLANTS (K062129)Institut Straumann AG2006-10-20
SUPER ORTHODONTIC SCREW (K062156)Osstem Implant Co., Ltd.2006-10-20
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (K062647)Omega Medical Imaging, Inc.2006-10-20
OCCLUSION BALLOON (K062202)Boston Scientific Corp2006-10-20
SAGEMAX Z-BLANK (K062695)Sagemax Bioceramics, Inc.2006-10-20
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (K062870)Kensey Nash Corp.2006-10-20
MODIFICATION TO GLIDESHEATH (K062858)Terumo Medical Corp.2006-10-20
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 (K062251)St Jude Medical2006-10-20
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 (K062832)C.R. Bard, Inc.2006-10-20
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K062882)Suqian Green Glove Co., Ltd.2006-10-20
BIOLUCENT APPLICATOR KIT (K062830)Biolucent, Inc.2006-10-20
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062722)Trek Diagnostic Systems, Inc.2006-10-20
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID (K062705)Dade Behring, Inc.2006-10-20
IRI INTEGRATED RETINAL IMAGER (K062295)Medivision Medical Imaging, Ltd.2006-10-20
INTEGRA SL (K062147)Direx Systems Corp.2006-10-20
SBI CARPAL FUSION PLATE (K062903)Small Bone Innovations, Inc.2006-10-20
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 (K061651)Apple Medical Corp.2006-10-20
SUPERSTITCH 5F, 12F, AND EL (K062125)Sutura, Inc.2006-10-19
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE (K062336)Optimedica Corporation2006-10-19
SYNTHES LCP DISTAL FEMUR PLATES (K062564)Synthes (Usa)2006-10-19
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM (K063047)Medhot Thermal Imaging, Inc.2006-10-19
BELMONT BUDDY PLUS FLUID WARMER (K062774)Belmont Instrument Corp.2006-10-19
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM (K062494)Ebi, L.P.2006-10-19
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT (K061681)Biomet Manufacturing Corp2006-10-19
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY (K061863)Arthrex, Inc.2006-10-19
K-SPRAY, MODEL 085-2715 (K062418)Scican2006-10-19
OSTEOPORE TCP (K062496)Spinecraft, Inc.2006-10-19
FRS SCREW (K062352)DePuy Orthopaedics, Inc.2006-10-19
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION (K060967)Stereotaxis, Inc.2006-10-19
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM (K062831)Life Spine2006-10-19
NEXUS 3 (K062519)Kerr Corporation2006-10-19
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 (K062079)Baxter Healthcare Corporation2006-10-19
CLARITY MODIFIED CERAMIC BRACKETS (K062305)3M Unitek2006-10-18
NASOPORE EAR, MODELS ND04, ND05 (K062540)Polyganics B.V.,2006-10-18
AMNIOSTAT-FLM-PG (K061549)Irvine Scientific Sales Co., Inc.2006-10-18
ENSEAL PTC TISSUE SEATING SEALING DEVICE (K062949)Surgrx, Inc.2006-10-18
CENTARISONE RIS/PACS (K063037)Centarisone, LLC2006-10-18
ENSEAL PTC TISSUE SEALING DEVICE (K063097)Surgrx, Inc.2006-10-18
QUANTA LITE PBC SCREEN IGG/IGA ELISA (K061842)Inova Diagnostics, Inc.2006-10-18
LIAISON EA IGG (K060204)DiaSorin, Inc.2006-10-18
PORTEX EPIDURAL CATHETER (K062005)Smiths Medical Asd, Inc.2006-10-18
ADMIRAL XTREME PTA CATHETER (K062809)Invatec Innovative Technologies2006-10-18
SYNGO LUNG CAD (K063877)Siemens Medical Solutions USA, Inc.2006-10-18
TORBOT VASCULAR COMPRESSION GARMENTS (K061411)Torbut Group, Inc.2006-10-18
PRISMA SYSTEM R03.10A (K062090)Gambro Renal Products2006-10-18
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 (K061661)Advanced Infusion, Inc.2006-10-18
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K062786)Given Imaging , Ltd.2006-10-18
RESUSCITATION TIMER, MODEL L770-CPR (K062080)Allied Healthcare Products, Inc.2006-10-18
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 (K062268)Philips Medical Systems North America Co.2006-10-18
MASTALEX -MRSA, MODEL RST501 (K062864)Mast Group , Ltd.2006-10-18
DENSHIELD TREATMENT FOR SENSITIVE TEETH (K061359)Novamin Technology, Inc.2006-10-18
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS (K061172)PAJUNK GmbH Medizintechnologie2006-10-17
POWERTOME PERIOTOME (K063007)Westport Medical, Inc.2006-10-17
SOLITAIRE ANTERIOR SPINAL SYSTEM (K062810)Ebi, L.P.2006-10-17
FOX SV PTA CATHETER (K062843)Abbott Laboratories2006-10-17
SERENO ELECTRONIC STETHOSCOPE (K062481)Pishon High Tech Co., Ltd.2006-10-16
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY (K052992)Conmed Linvatec2006-10-16
ABL8X7 FLEX (K051968)Radiometer Medical Aps2006-10-16
CODMAN VPV SYSTEM, MODEL 82-3192 (K061876)Codman & Shurtleff, Inc.2006-10-16
AXIOM PULSED LIGHT SYSTEM (K062312)General Project S.R.L.2006-10-16
CONFIDANT 2.0 (K062215)Confidant, Inc.2006-10-16
MANUEL SAFTEY SYRINGE PARTS 1 & 2 (K060772)Medsafe Asa2006-10-16
NOVASPINE POWERED SUCTION PUMP PRO-1 (K062456)Novaspine, LLC2006-10-16
AUDIT MICROCV IMMUNOASSAY LINEARITY SET (K062668)Aalto Scientific, Ltd.2006-10-16
PMP4 APPLICATION (K061428)Card Guard Scientific Survival , Ltd.2006-10-16
CAREVENT (K062240)Chief Medical, LLC2006-10-16
POLARCOAT (K052907)Patton Surgical Corp.2006-10-16
COMFORT SCOOTER, MODEL LY-EW415 (K063032)Comfort Orthopedic Co., Ltd.2006-10-16
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Every clearance here is in the API, with alerts when new ones post.