Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL (K100063)Ev3, Inc.2010-02-02
EVOLVE EPS ORTHOLOC (K100146)Wrightmedicaltechnologyinc2010-02-02
ATLAS INTERVERTEBRAL BODY CAGE (K092774)Spinal Edge, LLC2010-02-02
DEPUY FRACTURE AND FUSION PLATING SYSTEM (K093474)DePuy Orthopaedics, Inc.2010-02-02
IMPLANTABLE CLIP (K100090)Genicon2010-02-02
EC50 MICRO+ SMOKERLYZER (K082315)Bedfont Scientific, Ltd.2010-02-01
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS (K093563)Philips Ultrasound, Inc.2010-02-01
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE (K093112)Coloplast Manufacturing Us, LLC2010-02-01
LAP LOOP (K092897)Medsys, S.A.2010-02-01
TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 (K092821)Agency For Medical Innovations, Inc.2010-02-01
1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL (K093284)Invivo Corporation2010-02-01
FLEXPEN NEEDLE (K090111)Novo Nordisk, Inc.2010-02-01
QUANTA LITE APS/PT IGG AND IGM ELISA (K090755)Inova Diagnostics, Inc.2010-02-01
GEM FLOW COUPLER DEVICE AND SYSTEM (K093310)Synovis Micro Companies Alliance, Inc.2010-02-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR (K093727)Zibo Bolin Gloves Co., Ltd.2010-02-01
STATNET, MODEL 3100 (K092828)Hydrodot, Inc.2010-01-29
URSA ANGIOGRAPHIC CATHETER (K090427)Curative Medical Technology, Inc.2010-01-29
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 (K100014)Andon Health Co, Ltd.2010-01-29
TRILOGY 200 VENTILATOR (K093416)Respironics, Inc.2010-01-29
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR (K100117)Shenzhen Dongdixin Technology Co., Ltd.2010-01-29
R & D SYSTEMS XERET HEMATOLOGY CONTROL (K100050)R&D Systems, Inc.2010-01-29
MISSION BREATH ALCOHOL DETECTOR (K093143)ACON Laboratories, Inc.2010-01-28
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, (K092508)Smith & Nephew, Inc.2010-01-28
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 (K091794)Steve Islava2010-01-28
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM (K100067)Toshiba America Medical Systems, In.C2010-01-28
SR PHONARES NHC (K093331)Ivoclar Vivadent, Inc.2010-01-28
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE (K091583)Medefil, Inc.2010-01-28
DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY (K093822)Shepherd Scientific, Inc.2010-01-28
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION (K093433)Howmedica Osteonics Corp.2010-01-28
SHOULDER SPEEDER COIL (K093667)Quality Electrodynamics2010-01-28
THERMOTEX PLATINUM SYSTEM (K092589)Eas Consulting Group, LLC2010-01-28
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (K093386)Bfw, Inc.2010-01-28
UPCERA ZIRCONIA BLANKS (K093560)Shenyang Upcera Co., Ltd.2010-01-28
ATLANTIS SLIT LAMP (K093021)Us Opthalmic, LLC2010-01-28
TAKE 1 ADVANCED RIGID TRAY (K092176)Kerr Corporation2010-01-28
VALEO SPACER SYSTEM (K091278)Amedica Corp.2010-01-28
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM (K091428)Ndd Medizitechnik AG2010-01-27
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER (K092540)Rsb Spine, LLC2010-01-27
PREMISE FLOWABLE MODIFIED (K093484)Kerr Corporation2010-01-27
SET GRI-FILL 3.0 (K093182)Laboratorios Grifols, S.A.2010-01-27
EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD (K093271)Victus, Inc.2010-01-27
AIRVO SERIES HUMIDIFIERS (K092846)Fisher & Paykel Healthcare, Ltd.2010-01-27
ALPHAXENON LIGHT 180 W AND 300 W (K093125)Gimmi GmbH2010-01-27
BUTTERFLY TONER MODEL GYM070 (K093368)Global Marketing Partners Dba Gymmax USA2010-01-27
IG 4 IMAGE GUIDED SYSTEM (K093995)Veran Medical Technologies, Inc.2010-01-27
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES (K093070)Sunrise Medical2010-01-26
MICROSCAN MICROSTREP PLUS, MODEL B1027-201 (K091949)Siemens Healthcare Diagnostics2010-01-26
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (K093363)Smith & Nephew, Inc.2010-01-26
ATRIUM C-QUR OVT MESH (K100076)Atrium Medical Corp.2010-01-26
RESPISENS (K092845)Nomics2010-01-26
JALOSKIN (K092257)Fidia Advanced Biopolymers Srl2010-01-26
MERIDIAN GUIDEWIRE (K093681)Ev3 Neurovascular2010-01-26
SOLO MICROPUMP INSULIN DELIVERY SYSTEM (K093364)Medingo , Ltd.2010-01-25
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 (K092106)Taidoc Technology Corporation2010-01-25
ANY PLUS SPINAL FIXATION SYSTEM (K091717)GS Medical Co., Ltd.2010-01-25
TURBO-TANDEM SYSTEM MODEL 472-110 (K094036)Spectranetics Corp.2010-01-25
RAPIDSORB PLUS SCREW SYSTEM (K093464)Synthes (Usa)2010-01-25
TIGR SURGICAL MESH , MODEL WK-6 (K092224)Novus Scientific Pte, Ltd.2010-01-25
GRIND NO MORE GENERATION II (K094020)Ranir, LLC2010-01-25
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (K093985)Nipro Medical Corp.2010-01-22
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM (K093823)Health & Life Co., Ltd.2010-01-22
METAPHOR METABOLIC MONITOR (K093080)Treymed, Inc.2010-01-22
ACP4 SPINAL IMPLANT SYSTEM (K092360)X-Spine Systems, Inc.2010-01-22
MODIFIED: NEWDEAL HALLU PLATES (K093781)Newdeal Sas2010-01-22
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS (K092098)Smith & Nephew, Inc.2010-01-22
BTI DENTAL IMPLANT 5.5-6.5 (K091387)B.T.I. Biotechnology Institute, Sl.2010-01-22
OWL UNIVERSAL RF SYSTEM URF-3AP (ML) (K093185)Diros Technology, Inc.2010-01-22
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K092818)Respironics, Inc.2010-01-22
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID (K093162)Fotona D.D.2010-01-22
OSV II LOW FLOW LOW PRO VALVE (K093968)Integra LifeSciences Corporation2010-01-22
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE (K091328)Sophysa SA2010-01-22
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS (K093986)Sorin Group Italia S.R.L.2010-01-22
LAPAROSCOPIC RETRACTORS (K092684)Cardinal Health, Inc.2010-01-22
BIOFOAM BONE WEDGE MODEL ASSORTED (K093950)Wrightmedicaltechnologyinc2010-01-22
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO (K092388)Integra LifeSciences Corporation2010-01-21
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC (K093947)Merit Medical Systems, Inc.2010-01-21
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) (K093918)Pathway Medical Technologies, Inc.2010-01-21
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V (K093919)MicroVention, Inc.2010-01-21
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS (K091863)Aubrey, Inc.2010-01-21
MEDLINE RED RUBBER URETHRAL CATHETER (K092250)Medline Industries, Inc.2010-01-21
ENDOFORM DERMAL TEMPLATE (K092096)Mesynthes, Ltd.2010-01-21
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II (K092124)Trans1 Incorporated2010-01-21
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK (K090953)Praxim Medivision, SA2010-01-21
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) (K093217)Intuitive Surgical, Inc.2010-01-21
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S (K093944)Medacta International S.A.2010-01-21
QUANTUM M COMPOSITE NAILING SYSTEM (K091425)N.M.B. Medical Applications, Ltd.2010-01-21
ENDURAVENT-5 VENTILATOR (K092263)Providence Global Medical, Inc.2010-01-21
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O (K093195)Cook Ireland, Ltd.2010-01-21
FOGARTY OCCLUSION CATHETER (K093911)Edwards Lifesciences, LLC2010-01-21
ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT (K093075)Aragon Surgical, Inc.2010-01-21
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER (K093370)Fu Hong Industries , Ltd.2010-01-21
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 (K093972)Becton, Dickinson & CO2010-01-21
ODYSSEY WORKSTATION (K093092)Stereotaxis, Inc.2010-01-21
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR (K093427)Fujifilm Medical System U.S.A., Inc.2010-01-21
DENTAL MERCURY (K093587)Dmg USA, Inc.2010-01-21
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO (K093593)Medtrade Products Limited2010-01-20
THE PICC WAND PEELABLE SAFETY INTRODUCER (K093022)Access Scientific, Inc.2010-01-20
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) (K093172)Dynacardia, Inc.2010-01-20
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX (K082805)Q Urological Corporation2010-01-20
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) (K092110)Sonoma Orthopedic Products, Inc.2010-01-20
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Every clearance here is in the API, with alerts when new ones post.