Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GFX NERVE ABLATION SYSTEM (K063753)Aci, Inc.2007-06-20
QUANTA PLEX CELIAC IGA PROFILE (K063818)Inova Diagnostics, Inc.2007-06-20
CLEARFIL MAJESTY POSTERIOR PLT (K071169)Kuraray Medical, Inc.2007-06-20
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 (K071399)Sicel Technologies, Inc.2007-06-20
THD (K070815)G.F. S.R.L.2007-06-20
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET (K063282)B.Braun Medical, Inc.2007-06-20
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) (K070490)Advanced Circulatory Systems, Inc.2007-06-20
MESOSFOL SURGICAL FILM (K062558)Biomet Manufacturing Corp2007-06-20
FEEL-JECT INSULIN SYRINGE (K070917)Feel Tech2007-06-20
GENESISCS COMPONENT CONCENTRATING SYSTEM (K070666)Perfusion Partners & Assoc., Inc.2007-06-20
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 (K071195)Ani-Kal Ii, LLC2007-06-20
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (K071180)Engineered Medical Solutions Co., LLC2007-06-20
UNITE BIOMATRIX (K071425)Pegasus Biologics, Inc.2007-06-20
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM (K071233)Kub Technologies, Inc.2007-06-20
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS (K071232)Tomtec Imaging Systems GmbH2007-06-20
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 (K063232)Biokit, S.A.2007-06-19
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 (K071125)Aga Medical Corp.2007-06-18
BIS EEG MONITOR VIEW (K062613)Aspect Medical Systems, Inc.2007-06-18
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE (K071020)GE Healthcare2007-06-18
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 (K070288)Medtronic Vascular2007-06-18
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387)Fresenius Medical Care North America2007-06-15
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING (K070639)Siam Sempermed Corp., Ltd.2007-06-15
APNEALINK (K070263)Resmed Germany, Inc.2007-06-15
HYDROCOIL EMBOLIC SYSTEM (HES) (K070656)MicroVention, Inc.2007-06-15
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K070901)Bioplate, Inc.2007-06-15
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 (K070869)Dentalez, Inc.2007-06-15
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING (K063876)Medivators Reprocessing Systems2007-06-14
LUMILOC (TM) SAFETY INTRODUCER NEEDLE (K070449)Specialized Health Products International, Inc.2007-06-14
STOCKERT NEURO N50, MODEL12267 (K070336)Stockert GmbH2007-06-14
AOS TIBIAL NAIL (K070444)Advanced Orthopaedic Solutions, Inc.2007-06-14
CANNULATED SCREW (K070617)Fournitures Hospitalieres Industrie2007-06-14
PROXENON 350, MODEL 902XX (K071218)Welch Allyn, Inc.2007-06-14
BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX (DEN070006)Inverness Medical Professional Diagnostics-Binax2007-06-13
NORAS OR HEAD HOLDER (K071179)Siemens Medical Solutions USA, Inc.2007-06-13
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 (K070198)Ethicon Endo-Surgery, LLC2007-06-13
POLARCATH PERIPHERAL DILATATION SYSTEM (K071042)Boston Scientific Corp2007-06-13
MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS (K071426)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2007-06-13
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM (DEN060002)Inrange Systems, Inc.2007-06-13
STRIDE MICROCATHETER (K062885)Asahi Intecc Co., Ltd.2007-06-13
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 (K070255)Nova Biomedical Corp.2007-06-13
NASOPHARYNGOSCOPE, BRONCHOSCOPE (K070580)Xion GmbH2007-06-13
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 (K070853)Dade Behring, Inc.2007-06-13
LOWTOP PEDICLE SCREW SYSTEM (K070933)Sanacor2007-06-13
MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM (K071376)Vertebron, Inc.2007-06-13
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS (K071458)Integra LifeSciences Corporation2007-06-13
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES (K071203)Optikem International, Inc.2007-06-13
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR (K062883)Gereonics, Inc.2007-06-13
PRONTO .035 EXTRACTION CATHETER (K070403)Vascular Solutions, Inc.2007-06-13
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES (K071378)E-Z-Em, Inc.2007-06-13
X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR (K071408)Imaging Dynamics Company , Ltd.2007-06-13
ULTRAEZ DESENSITIZING GEL (K061438)Ultradent Products, Inc.2007-06-12
THERMAGE THERMACOOL SYSTEM (K052936)Thermage, Inc.2007-06-12
CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737)Horiba Abx2007-06-12
MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY (K071069)Viasys Sleep Systems, LLC2007-06-12
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM (K071403)Imaging Dynamics Company , Ltd.2007-06-11
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE (K071153)Given Imaging , Ltd.2007-06-11
BC-3200 AUTO HEMATOLOGY ANALYZER (K063407)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-06-11
ALLEZ SPINE CROSS CONNECTORS (K070460)Allez Spine, LLC2007-06-11
REVOIS IMPLANT SYSTEM (K063106)Curasan AG2007-06-11
MODIFICATION TO: INTERPLATE VBR SYSTEM (K071372)Rsb Spine, LLC2007-06-11
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL (K070453)Olympus Life & Material Science Europa GmbH (Irish2007-06-11
ISSYS LP SPINAL FIXATION SYSTEM (K070281)Custom Spine, Inc.2007-06-11
ALTIVA CLASSIC ACP SYSTEM (K070891)Altiva Corp.2007-06-11
VITALSTIM EXPERIA (K070425)Chattanooga Group2007-06-11
LRTM SURGICAL MESH (K070560)Lifecell Corp.2007-06-11
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) (K063498)Sebia2007-06-11
PORTACLAMP FLEX (K070380)Cardio Life Research, S.A.2007-06-08
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810)Biokit, S.A.2007-06-08
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM (K071409)Imaging Dynamics Company , Ltd.2007-06-08
SYNGO CT ONCOLOGY SOFTWARE PACKAGE (K071310)Siemens AG2007-06-08
MASIMO PATIENT SAFETY NET (K071047)Masimo Corporation2007-06-08
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM (K071402)Imaging Dynamics Company , Ltd.2007-06-08
SYNAPSE SYSTEM (K070573)Synthes Spine Co.Lp2007-06-08
HYPERTHERMIA PUMP (K070654)Belmont Instrument Corp.2007-06-08
LMS-LIVER (K071241)Median Technologies2007-06-08
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS (K062484)Flaem Nuova S.P.A.2007-06-08
OPTICAL GUIDANCE PLATFORM (K071360)Varian Medical Systems, Inc.2007-06-08
STERILIZATION POUCH WITH INDICATORS (K062704)Winner Industries (Shenzhen) Co., Ltd.2007-06-08
FUTURABOND DC/SINGLE DOSE (K070723)Voco GmbH2007-06-07
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 (K063740)Kci USA, Inc.2007-06-07
ER35 ERO-SCAN PRO HEARING TEST SYSTEM (K070880)Etymotic Research, Inc.2007-06-07
OPTECURE; OPTECURE + CCC (K063685)Exactech, Inc.2007-06-07
ELECTRODE/EXTENSION CABLES, MODELS ATAR (K070926)Oscor, Inc.2007-06-07
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K070395)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2007-06-07
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE (K070760)Derma Care Plus Products, LLC2007-06-07
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (K062541)Innova Vision, Inc.2007-06-07
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (K071140)Top Spins, Inc.2007-06-07
SACS EEG WORKSTATION A7 (K071109)Sacs Medical AB2007-06-07
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS (K070695)Zimmer, Inc.2007-06-07
ARTELON STT SPACER (K061956)Artimplant AB2007-06-07
HEALTH CHECK KIOSK (K063008)Xperex Corporation2007-06-07
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 (K070320)Edwards Lifesciences Services GmbH2007-06-07
ULCELOOCIN ORAL ULCER PATCH (K070842)Sunshine International Group, Inc.2007-06-07
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 (K063692)Kci USA, Inc.2007-06-07
PAJUNKS EPILONG SET PEDIATRIC (K062902)PAJUNK GmbH Medizintechnologie2007-06-07
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (K070756)Smith & Nephew, Inc.2007-06-06
BD TRITEST CD3/CD4/CD45, MODEL 340383 (K071143)Bd Biosciences2007-06-06
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (K071141)Bd Biosciences2007-06-06
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES (K070946)Synthes (Usa)2007-06-06
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM (K071142)Datex-Ohmeda2007-06-06
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