Atlas FDA

2007

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

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RecordFirmDate
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 (K071514)Possis Medical, Inc.2007-07-31
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE (K070062)Diesse Diagnostica Senese S.P.A.2007-07-30
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR (K071123)Xuzhou Full Sun Medical Products , Ltd.2007-07-30
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES (K071856)Zimmer, Inc.2007-07-30
ACON U120 URINE ANALYZER, MODEL U111-101 (K070929)ACON Laboratories, Inc.2007-07-30
COBAS C 111 ANALYZER (K071211)Roche Diagnostics2007-07-30
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 (K071791)Codman & Shurtleff, Inc.2007-07-30
A-VIEW BASIC AND PLUS (K070515)Cordatec N.V.2007-07-30
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS (K071972)Agfa Healthcare Corp.2007-07-30
SIS SINUS IMPLANT STABILIZER (K062436)Mondeal Medical Systems GmbH2007-07-30
MBCP+ (K063527)Biomatlante2007-07-30
MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE (K071186)Ambu A/S2007-07-30
ZEO CE LIGHT & ZEO QUICK PORCELAIN (K071201)Xpdent Corp2007-07-30
SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K071571)Surgiquest, Inc.2007-07-30
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM (K071105)Osteomed LP2007-07-30
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES (K071208)High Momentum Sdn Bhd2007-07-30
ENDODRAPE (K070406)Vortek Surgical, LLC2007-07-30
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 (K071212)Respironics California, Inc.2007-07-30
MAXINSIGHT (K070358)Eemagine Medical Imaging Solutions GmbH2007-07-30
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 (K072000)Toshiba America Medical Systems, In.C2007-07-30
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY (K071587)Inverness Medical Innovations, Inc.2007-07-30
VU E*POD VERTEBRAL BODY REPLACEMENT (K071031)Theken Spine, LLC2007-07-30
SYNGO TRUED (K071950)Siemens Medical Solutions USA, Inc.2007-07-27
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 (K071821)Tonica Elektronik A/S2007-07-27
MECHANICAL WHEELCHAIR - L-FRAME SERIES (K071444)Colours 'N Motion2007-07-27
MODIFICATION TO VELASMOOTH, SHAPER (K070092)Syneron Medical, Ltd.2007-07-27
ENDOCERVICAL ELECTRODE # 2 (K070877)Modern Medical Equipment Mfg., Ltd.2007-07-27
MODEL SEGAEGO 4D SCOOTER (K071282)Dalton Medical Corp.2007-07-27
D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW (K063355)Novosci Corp.2007-07-27
SPINAL SPHERES (K062992)Interbody Innovations, Llp2007-07-27
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) (K063275)Terray Corp.2007-07-27
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES (K063757)Shanghai Motex Healthcare Co., Ltd.2007-07-27
SYSTEM, TOMOGRAPHY, COMPUTED EMISSION (K071503)Syntermed, Inc.2007-07-26
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS (K063495)Biomaterials Korea, Inc.2007-07-26
DEMI (K071251)Kerr Corporation2007-07-26
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515 (K071819)Ncontact Surgical, Inc.2007-07-26
PORTRAIT PSR (K071786)Rhytec Incorporated2007-07-26
SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS (K061914)Sport-Elec S.A.2007-07-26
MODEL SEGAEGO 3D SCOOTER (K071284)Dalton Medical Corp.2007-07-26
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) (K071060)Sgmp Co., Ltd.2007-07-26
PSI BANDS (K070766)Psi Health Solutions, Inc.2007-07-26
MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE (K070598)Memometal Technologies2007-07-26
BIOMET VARIABLE LOCKING PLATE SYSTEM (K071325)Biomet Trauma2007-07-26
ANEUROPLASTIC, MODEL 43-1290 (K071776)Codman & Shurtleff, Inc.2007-07-26
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM (K063427)Lynton Lasers Limited2007-07-25
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES (K070737)Prosurg, Inc.2007-07-25
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES (K071209)High Momentum Sdn Bhd2007-07-25
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE (K053613)Theo Manufacturing BV2007-07-25
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS (K071784)DePuy Orthopaedics, Inc.2007-07-25
PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS (K071174)Abbott Spine, Inc.2007-07-25
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC (K070175)Medtrade Products , Ltd.2007-07-25
UNO (K071131)3M Espe AG Dental Products2007-07-25
CERMET III ACETABULAR CUP SYSTEM (K071583)Implants International, Ltd.2007-07-25
MICROTARGETING GUIDELINE 4000 (K071364)FHC, Inc.2007-07-25
INION BIORESTORE (K070784)Inion OY2007-07-24
DL900 SERIES HOLTER RECORDER (K071733)Braemar, Inc.2007-07-24
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION (K070767)Lapis Lazuli International NV2007-07-24
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) (K071119)Gx Corporation Sdn Bhd2007-07-24
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (K071572)Terumo Corp.2007-07-23
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT (K071191)Novartis Nutrition Corp.2007-07-23
IMAGIC V2.0 (K071602)Ashva Technologies, Pvt., Ltd.2007-07-23
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL (K071847)Shanghai Chenguang Medical Technologies Co, Ltd.2007-07-23
UNIWEB, VERSION 5.0 (K071166)Electronic Business Machine Co., Ltd. (Ebm)2007-07-23
TRACKLEAF-10 (K071701)Direx Systems Corp.2007-07-23
ONE STEP HCG PREGNANCY TEST (K062703)Ai DE Diagnostic Co., Ltd.2007-07-23
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE (K071027)Tribofilm Research, Inc.2007-07-20
WHEELCHAIR MODEL STS (K071390)Innovative Products, Inc.2007-07-20
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K071300)Smith & Nephew, Inc.2007-07-20
ALLEGRO OCULYZER (K071183)Wavelight AG2007-07-20
GSO GS1 SPINAL SYSTEM (K070966)Gold Standard Orthopaedics, LLC2007-07-20
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM (K071147)Nexa Orthopedics, Inc.2007-07-20
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 (K071801)Ortho-Clinical Diagnostics, Inc.2007-07-20
STRYKER PEEK TWINLOOP TAC (K070882)Stryker Endoscopy2007-07-20
JAZZ BLOOD GLUCOSE MONITORING SYSTEM (K071393)Agamatrix2007-07-20
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 (K071714)Orthosoft, Inc.2007-07-20
BUSSE EPIDURAL CATHETER (K070465)Busse Hospital Disposables, Inc.2007-07-19
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS (K071676)Exactech, Inc.2007-07-19
VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (K071292)Richard Wolf Medical Instruments Corp.2007-07-19
MODIFICATION TO KAVO QUATTROCARE (K071288)Sybron Dental Specialties, Inc.2007-07-19
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE (K071745)Baylis Medical Co., Inc.2007-07-19
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT (K071735)Symbios Medical Products, LLC2007-07-19
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 (K071665)Biotronik, Inc.2007-07-18
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (K071550)Cp Medical2007-07-18
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER (K071381)Varian Medical Systems2007-07-18
ACUMED CONGRUENT BONE PLATE SYSTEM (K071715)Acumed, LLC2007-07-18
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 (K071163)Weinmann Gerate Fur Medizin GmbH + Co. KG2007-07-18
SMARTEP, MODEL M010000 (K070608)Intelligent Hearing Systems2007-07-18
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 (K071673)Onc Solutions, Inc.2007-07-18
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM (K070346)Dade Behring, Inc.2007-07-18
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, (K071882)Shanghai Chenguang Medical Technologies Co, Ltd.2007-07-18
MEDLINE LATEX FOLEY CATHETER (K071423)Medline Industries, Inc.2007-07-18
VR LUNG ELECTROSONOGRAPH (K061495)Deep Breeze , Ltd.2007-07-18
SOMNOSCREEN EEG10-20 (K071556)Somnomedics GmbH2007-07-18
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 (K070461)STERIS Corporation2007-07-17
MEDICOM SELF-SEALING STERILIZATION POUCH (K070428)A.R. Medicom, Inc.2007-07-17
OHMEDA MEDICAL GIRAFFE OMNIBED (K071175)GE Healthcare2007-07-17
HERMES BOND 3 (K071260)3M Espe AG Dental Products2007-07-17
NON-ABSORBABLE SILK SUTURE (K071111)Arrow Intl., Inc.2007-07-17
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400 (K070435)Whittlestone, Inc.2007-07-17
XTAC (K061934)Osteogenics, Inc.2007-07-17
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