Atlas FDA

2007

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

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RecordFirmDate
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (K070881)Sapimed S.P.A.2007-09-26
P.004 ABUTMENTS (K071919)Straumann USA (On Behalf of Institut Straumann Ag)2007-09-26
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT (K071998)Arrow Intl., Inc.2007-09-26
P.004 NC GOLD ABUTMENT FOR CROWNS (K072497)Institut Straumann AG2007-09-26
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) (K071962)Cordis Neurovascular, Inc.2007-09-26
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (K070339)Cincinnati Sub-Zero Products, Inc.2007-09-26
OSSIFUSE BONE SUBSTITUTE MATERIAL (K072355)Etex Corp.2007-09-26
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM (K072541)Senorx, Inc.2007-09-25
HARMONIC 10CM COMBINATION HOOK BLADE (K072203)Ethicon Endo-Surgery, LLC2007-09-25
CLEAR IMAGE ALIGNER (K071970)Specialty Appliance Works, Inc.2007-09-25
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM (K072392)Siemens Medical Solutions USA, Inc.2007-09-25
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR (K072542)Medegen Medical Manufacturing System2007-09-25
AVIAFIT PULSATING LEGBAND (K071744)Flowmedic , Ltd.2007-09-25
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX (K071805)Datascope Corp.2007-09-25
MODIFICATION TO RADIUS SNARE (K071457)Radius Medical Technologies, Inc.2007-09-25
BRAINSUITE NET (K070556)Brainlab AG2007-09-25
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K071741)Migada Plant2007-09-24
GENERAL SURGERY DRAPES (K070432)Welmed, Inc.2007-09-24
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675)Diagnostic Hybrids, Inc.2007-09-24
MARROWMINER (K071732)Stemcor Systems, Inc.2007-09-24
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY (K072443)Ortho-Clinical Diagnostics, Inc.2007-09-24
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 (K071510)Focus Diagnostics, Inc.2007-09-24
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML (K070809)Becton, Dickinson & CO2007-09-24
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (K071346)Immco Diagnostics, Inc.2007-09-24
APEXNRG-BLUE ELECTRONIC APEX LOCATOR (K071133)Medicnrg , Ltd.2007-09-21
VISULAS TRION (K072514)Carl Zeiss Meditec, AG2007-09-21
GLOBUS GENESY 1100 STIMULATOR (K071431)Domino S.R.L.2007-09-21
ZIP'R PC (K072224)Global Fabtech Wheelchair (Shanghai) Co., Ltd.2007-09-21
TILITE AERO X (K072311)Tisport, LLC2007-09-21
POWRSYRINGE INJECTOR (K072318)Pinyons Medical Technology, Inc.2007-09-21
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A (K072337)Wu'S Tech Co., Ltd.2007-09-21
MODIFICATION TO PASSMED SPINAL SYSTEM (K070276)Medicrea Technologies2007-09-21
GS SYSTEM (K063861)Osstem Implant Co., Ltd.2007-09-21
MODIFICATION TO: UNITY NETWORK ID (K071982)Ge Medical Systems Information Technologies2007-09-21
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (K070291)Medix I.C.S.A.2007-09-21
PLANMECA PROONE (K072244)Planmeca Oy2007-09-21
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K072504)Accuray Incorporated2007-09-21
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K072279)Hitachi Medical Systems America, Inc.2007-09-21
PLANET 55 (K071472)Larsen & Toubro Limited2007-09-21
MULTIPLE BRAND MALE LATEX CONDOM (K070937)Nulatex Sdn. Bhd.2007-09-21
POWRSYRINGE MONITOR (K072345)Pinyons Medical Technology, Inc.2007-09-21
CERVITEC PLUS (K072338)Ivoclar Vivadent, Inc.2007-09-21
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798)Diagnostic Hybrids, Inc.2007-09-21
FIXAFLOSS (K071615)Sybron Dental Specialties, Inc.2007-09-21
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE (K072384)Kensey Nash Corp.2007-09-21
EMBRACE GEL (K072515)Orison Corporation2007-09-20
ALWAYS MENSTRUAL PADS (K071827)Procter & Gamble, Inc.2007-09-20
BIOMET FEMORAL LOCKING NAIL SYSTEM (K072161)Biomet Manufacturing Corp2007-09-20
CONFORMIS METAL BACKED TIBIAL COMPONENT (K072368)Conformis, Inc.2007-09-20
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM (K072489)Taidoc Technology Corporation2007-09-20
P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) (K070478)Straumann Manufacturing, Inc.2007-09-20
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) (K072440)Ortho-Clinical Diagnostics, Inc.2007-09-20
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (K061539)Clinical Innovations, LLC2007-09-20
S4 SPINAL SYSTEM (K071945)Aesculap Implant Systems2007-09-20
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR (K063297)Lightmed Corp.2007-09-20
STRYKER CROSSFIRE SYSTEM (K071859)Stryker Endoscopy2007-09-20
UCP MULTIPLE DRUG SCREEN TEST CUPS (K072062)Ucp Biosciences, Inc.2007-09-20
HARPOON SUTURE ANCHOR (K071816)Biomet Sports Medicine, Inc.2007-09-20
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 (K072034)Quanta System Spa2007-09-20
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM (K071439)Zimmer Dental, Inc.2007-09-20
FIBRINOGEN CALIBRATOR KIT (K072304)Dade Behring, Inc.2007-09-19
SPI EASY 4.0 ABUTMENT (K071453)Thommen Medical AG2007-09-19
MINI LED AUTOFOCUS (K072181)Satelec2007-09-19
NEURO WAVE 6 (K062003)Lhasa Oms, Inc.2007-09-19
PULL TAB SQUEEZE FLUSH (K070979)Icu Medical, Inc.2007-09-19
PERIPHERAL GUIDING SHEATH (K070816)Micrus Design Technology, Inc.2007-09-19
DORADO PTA BALLOON DILATATION CATHETER (K072283)Bard Peripheral Vascular, Inc.2007-09-19
PERMA FACIAL IMPLANTS (K071823)Surgisil2007-09-19
MODIFICATION TO SPINAL USA VBR SYSTEM (K070922)Spinal USA2007-09-19
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 (K063735)Presym, Inc.2007-09-19
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS (K071071)Smith & Nephew, Inc.2007-09-19
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (K072364)Pulsion Medical Systems AG2007-09-19
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL (K071929)Orthosoft, Inc.2007-09-19
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K071604)Alveolus, Inc.2007-09-19
INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC (K071922)Rsb Spine, LLC2007-09-18
MODIFICATION TO:TSRH SPINAL SYSTEM (K072317)Medtronic Sofamor Danek USA, Inc.2007-09-18
MODIFICATION TO HYPERQ SYSTEM (K072389)Biological Signal Processing, Ltd.2007-09-18
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (K071832)Medical Scientific, Inc.2007-09-18
SPORTMESH OR ARTELON TISSUE REINFORCEMENT (K071887)Artimplant AB2007-09-18
EYETRACKER/IDEAS (K070670)S.A. Instrumentation Difra2007-09-18
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR (K071553)Ndo Surgical, Inc.2007-09-18
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS (K072322)Smith & Nephew, Inc.2007-09-18
EOS (K071546)Biospace Med2007-09-18
EXPEDIUM SPINE SYSTEM (K070387)Depuy Spine, Inc.2007-09-18
MIDAS REX CURVED BUR (K072315)Medtronic Powered Surgical Solutions2007-09-18
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE (K072184)Orthovita, Inc.2007-09-18
NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM (K072357)Afp Imaging Corp.2007-09-18
BONEMEDIK, AND BONEMEDIK-S (K070897)Meta Biomed Co., Ltd.2007-09-17
SLEEVE AND BUTTON SOFT TISSUE DEVICES (K071704)Biomet Sports Medicine, Inc.2007-09-17
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971)Diazyme Laboratories2007-09-17
MONDEAL DISTAL RADIUS SYSTEM (K071798)Mondeal Medical Systems GmbH2007-09-17
LANX SPINAL FIXATION SYSTEM (K071877)Lanx, LLC2007-09-17
PRECIOUS PLUS GUIDE CATHETER (K072316)Asahi Intecc Co., Ltd.2007-09-17
HEMOSIL D-DIMER HS (K070927)Instrumentation Laboratory CO2007-09-17
INQU (K071428)Isto Technologies, Inc.2007-09-17
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (K070804)Nanosphere, Inc.2007-09-17
MONDEAL HAND CONTOUR SYSTEM (K071797)Mondeal Medical Systems GmbH2007-09-17
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS (K071157)Stryker Endoscopy2007-09-17
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT (K072439)Ge Medical Systems Ultrasound and Primary Care Dia2007-09-14
DISPOSABLE LAPAROSCOPIC INSTRUMENT (K070812)Modern Medical Equipment Mfg., Ltd.2007-09-14
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Every clearance here is in the API, with alerts when new ones post.