Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS (K110152)Spsmedical Supply Corp.2011-04-15
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI (K103662)Zimmer, Inc.2011-04-15
ATMOS E 201 THORAX AND ATMOS S 201 THORAX (K103042)Atmos, Inc.2011-04-15
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103527)International Biomedical, Ltd.2011-04-15
LANX SPINAL FIXATION SYSTEM (K103091)Lanx, Inc.2011-04-15
ANGIOSCULPT PTA SCORING BALLOON CATHETER (K110767)Angioscore, Inc.2011-04-15
ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606)Siemens Medical Solutions USA, Inc.2011-04-15
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM (K102418)Reverse Medical Corporation2011-04-15
OPTERTRAK LOGIC PSC TIBIAL INSERT (K110547)Exactech Sarasota2011-04-14
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT (K110368)Novabone Products, LLC2011-04-14
DISPOSABLE ENDOMETRIAL SUCTION CURETTE (K102847)Jiangsu Suyun Medical Materials Co., Ltd.2011-04-14
KELYNIAM CUSTOM SKULL IMPLANT (CSI) (K103582)Kelyniam Global, Inc.2011-04-14
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102085)Shijiazhuang Glory Plastic Co., Ltd.2011-04-14
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE (K101468)3M Company Corp2011-04-14
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K110887)Boston Scientific Corporation2011-04-14
APNEA RISK EVALUATION SYSTEM (ARES) (K110705)Advanced Brain Monitoring, Inc.2011-04-14
VICOR PD2I ANALYZER (K101867)Vicor Technologies, Inc.2011-04-14
NEWDEAL COMPRESSION PLATES (K093914)Newdeal Sas2011-04-14
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 (K110240)Smith & Nephew, Inc.2011-04-14
EVERCROSS 0.035 OTW PTA DILATATION CATHETER (K110319)Ev3, Inc.2011-04-14
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, (K101201)Kat Implants, LLC2011-04-13
EVA TPN BAG (K101412)Valmed S.R.L.2011-04-13
ONESTEP ADULT MULTI-FUNCTION ELECTRODE (K110742)ZOLL Medical Corporation2011-04-13
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) (K103556)Ivoclar Vivadent, Inc.2011-04-13
ARCHITEX SPACE MAINTENANCE SYSTEM (K110259)Medtronic Sofamor Danek USA, Inc.2011-04-13
DBX DEMINERALIZED BONE MATRIX PUTTY (K103795)Musculoskeletal Transplant Foundation2011-04-13
ODRC-DYNAMIC HIP SCREW SYSTEM (K103015)Orthopaedic Device Research Center2011-04-13
DBX DEMINERALIZED BONE MATRIX PUTTY (K103784)Musculoskeletal Transplant Foundation2011-04-13
MPS450 MULTIPARAMETER SIMULATOR (K103336)Fluke Biomedical2011-04-13
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (K102943)Coreleader Biotech Co., Ltd.2011-04-12
MEDVOXEL HEARTPRO SOFTWARE APPLICATION (K103565)Medvoxel Systems, Inc.2011-04-12
SYNGO.CT CARDIAC FUNCTION (K110366)Siemens AG2011-04-12
INFUSION ADAPTER C100 (K110023)Carmel Pharma Ab.2011-04-12
PROPEP DELIVERY DEVICE (K103200)Rhythmlink International, LLC2011-04-12
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 (K100321)Siemens Healthcare Diagnostics2011-04-12
WALDO PATIENT MONITOR (K110334)Waldo Health2011-04-12
LATARJET CORTICAL SCREW SET (K110763)T.A.G. Medical Products Corporation, Ltd.2011-04-11
TAPER OXINIUM FEMORAL HEAD (K110101)Smith & Nephew, Inc.2011-04-11
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE (K101072)Howmedica Osteonics Corp.2011-04-11
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (K101332)Aseptico, Inc.2011-04-11
TAKE 1 ADVANCED RIGID TRAY (K110092)Kerr Corporation2011-04-08
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET (K092269)Randox Laboratories, Ltd.2011-04-08
ATRICURE BIPOLAR SYSTEM (K110117)AtriCure, Inc.2011-04-08
APEX ER. YAG / IPL SYSTEM (K110304)Sandstone Medical Technologies, LLC2011-04-08
PAIRED HYDROGEL ELECTRODE (K110138)Neurovision Medical Products, Inc.2011-04-08
PORTABLE X-RAY SYSTEM (K103600)Digimed Corporation2011-04-08
AMBIT TUNNELER (K110814)Summit Medical Products, Inc.2011-04-08
ACAM 5 AUDIOMETER SYSTEM (K103298)Acousticon GmbH2011-04-08
A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 (K110802)Esaote, S.p.A.2011-04-08
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (K101754)Microgenics Corp.2011-04-08
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 (K101581)Intuitive Surgical, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (K101742)Microgenics Corp.2011-04-08
DENOVO TEDDY GEL INFANT HEEL WARMER (K103549)Denovo Products, LLC2011-04-08
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET (K103672)Ethicon Endo-Surgery, LLC2011-04-08
AGILIS ES STEERABLE INTRODUCER (K103083)St Jude Medical2011-04-08
PRELUDE III TONGUE SUSPENSION SYSTEM (K110127)Siesta Medical, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (K101752)Microgenics Corp.2011-04-08
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP (K110563)Therapeutics 101, Inc (Dba Pressure Point, Inc.)2011-04-08
D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER (K102212)Vascular Solutions, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (K101753)Microgenics Corp.2011-04-08
XEROS DRY MOUTH PUMP (K110116)Lorin Technologies Corporation2011-04-08
UF-760AG (K110920)Fukuda Denshi Co., Ltd.2011-04-08
ACUITY WHISPER VIEW GUIDE WIRES (K110479)Boston Scientific Corp2011-04-08
SMITH & NEWPHEW ULTRABRAID II SUTURE (K101377)Smith & Newphew, Inc.2011-04-08
LP CAGE (K110067)Medyssey Co, Ltd.2011-04-08
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS (K110667)Tomtec Imaging Systems GmbH2011-04-08
SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K101888)Hitachi Medical Systems America, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (K101744)Microgenics Corp.2011-04-08
DENV DETECT IGM CAPTURE ELISA (DEN100020)Inbios Intl., Inc.2011-04-08
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT (K103759)Astra Tech, Inc.2011-04-08
ULTIMATE VIT ENHAMCER (UVE) (K102222)Medical Instrument Development Laboratories, Inc.2011-04-08
ATAMA SYSTEM (K110411)Monteris Medical, Inc.2011-04-08
NICOLET WIRELESS EEG (K103140)Carefusion 209, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY (K101745)Microgenics Corp.2011-04-08
HYDROFIX VASO SHIELD (K101805)Mimedx Group, Inc.2011-04-08
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (K101746)Microgenics Corp.2011-04-08
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE (K110147)Sti Medical Systems, LLC2011-04-08
4D SONO-SCAN 1.0 (K110595)Tomtec Imaging Systems GmbH2011-04-07
COMBITRANS MONITORING SETS AND ACCESSORIES (K102033)B.Braun Melsungen AG2011-04-07
MOUNTAINEER OCT SPINAL SYSTEM (K110353)Depuy Spine, Inc.2011-04-07
UTA AND UHA (K102467)Uta2011-04-07
XVAC (K110782)Sorin Group Italia S.R.L.2011-04-07
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (K103318)Impact Instrumentation, Inc.2011-04-07
ACCULIF CAGE (K110270)Coalign Innovations, Inc.2011-04-07
EMS AIR-FLOW MASTER PIEZON (K110173)E.M.S Electro Medical Systems S.A2011-04-07
SYNAPSE 3D LIVER ANALYSIS (K110186)Fujifilm Medical System U.S.A., Inc.2011-04-07
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H (K110169)Siemens Healthcare Diagnostics2011-04-07
XPERT C. DIFFICLE/EPI ASSAY (K110203)Cepheid2011-04-07
PRONTOSAN WOUND IRRIGATION SOLUTION (K110744)B.Braun Medical, Inc.2011-04-06
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (K110499)Card Guard Scientific Survival , Ltd.2011-04-06
VELA XL (K103654)Starmedtec GmbH2011-04-06
RESUSCI FLOW; RESUSCI FLOW 104 (K102542)Atom Medical Corporation2011-04-06
SYNGO MBF (K110494)Siemens Medical Solutions USA, Inc.2011-04-06
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225)Alcopro, Inc.2011-04-06
DISPOSABLE BLLOD COLLECTION NEEDLE (K103587)Weihai Hongyu Medical Devices Co., Ltd.2011-04-06
TEMPOROMANIBULAR COIL 15 (K110373)Esaote, S.p.A.2011-04-06
NEWTOM 5G / NEWTOM 5G VERSION FP (K110260)Qr S.R.L.2011-04-06
MICROLIFE DIGITAL UNDERARM THERMOMETER (K103680)Microlife Intellectual Property GmbH2011-04-06
HAIRMAX LASERCOMB (K103368)Lexington International, LLC2011-04-06
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES (K100669)Us Medical Innovations, LLC2011-04-06
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Every clearance here is in the API, with alerts when new ones post.