Atlas FDA

2010

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

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RecordFirmDate
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER (K093594)Acclarent, Inc.2010-03-03
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; (K092331)Encore Medical L.P.2010-03-03
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (K093894)Anthogyr2010-03-03
MGB DISPOSABLE RETRIEVAL BAG LAPBAG (K093194)Mgb Endoskopische Gerate GmbH (Berlin)2010-03-03
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL (K090658)Synthes (Usa)2010-03-03
MD300C1 FINGERTIP PULSE OXIMETER (K093757)Beijing Choice Electronic Technololgy Co., Ltd.2010-03-03
VIT KIT - FREEZE AND THAW (K093273)Irvine Scientific Sales Co., Inc.2010-03-03
GRINDCARE (K092675)Medotech A/S2010-03-03
VINTAGE MP (K093559)Shofu Dental Corp.2010-03-03
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K093812)Siemens Medical Solutions USA, Inc.2010-03-03
GS III SYSTEM (K091208)Osstem Implant Co., Ltd.2010-03-03
BLOM-SINGER INDWELLING TEP OCCLUDER (K093258)Helix Medical, LLC2010-03-03
ZEISS INFRARED 800 WITH FLOW 800 OPTION (K100468)Carl Zeiss Surgical GmbH2010-03-03
COLOR LCD MONITOR, MODEL RADIFORCE RS210 (K092613)Eizo Nanao Corporation2010-03-03
TEMP IT (K100413)Spident Co., Ltd.2010-03-03
MEDACTA BIPOLAR HEAD (K091967)Medacta International S.A.2010-03-02
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC (K092902)Taidoc Technology Corporation2010-03-02
ANAPNOGUARD ENDOTRACHEAL TUBE (K093126)Hospitech Respiration , Ltd.2010-03-02
A-GRIX RESORBABLE BONE VOID FILLER (K091688)Ag Digital Technology Corp.2010-03-02
C-MOR VISUALIZATION DEVICE (K093717)Axis Surgical Technologies, Inc.2010-03-02
CHROMID VRE AGAR, MODEL: REF 43 851 (K091025)bioMerieux, Inc.2010-03-02
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM (K093764)Biotest Medical Corp.2010-03-02
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS (K092244)Diagnostic Group, LLC2010-03-01
GEL FILLED GUM SOOTHER (K092494)Luv N' Care, Ltd.2010-03-01
DIGITAL ULTRASOUND SCANNER (K100079)Shenzhen Well.D Medical Electronics Co., Ltd.2010-03-01
VASHE WOUND CLEANSING SYSTEM (K093155)Puricore, Inc.2010-03-01
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 (K100386)Changzhou Waston Medical Appliance Co., Ltd.2010-03-01
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS (K093414)Smiths Medical Asd, Inc.2010-03-01
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# (K093719)Osteogenics Biomedical, Inc.2010-03-01
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS (K082823)The Binding Site Group , Ltd.2010-03-01
NMI FC (K091634)Navilyst Medical, Inc.2010-03-01
ECHOPLAQUE (K092842)Indec Systems, Inc.2010-03-01
FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE (K093209)Cook, Inc.2010-02-26
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100074)Tangshan Jiteng Plastic Products Co., Ltd.2010-02-26
SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT (K083876)Cendres & Metaux SA2010-02-26
SPIROPALM (K093174)Cosmed Srl2010-02-26
ASAHI ZENYTEEX GUIDING CATHETER (K091188)Asahi Intecc Co., Ltd.2010-02-26
TELESENTRY, MODEL TS01 (K092947)Scottcare Corporation2010-02-26
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 (K093463)Care Fusion2010-02-26
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER (K100282)Terumo Corp.2010-02-26
TRAILRUNNER GUIDEWIRES (K092965)Lake Region Mfg., Inc.2010-02-26
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K100075)Tangshan Jiteng Plastic Products Co., Ltd.2010-02-26
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 (K093203)Medtronic, Inc.2010-02-26
EASYCARE ONLINE (K093684)Resmed, Ltd.2010-02-26
PYTON (K092733)Arm Medical Devices, Inc.2010-02-26
ASEPT PERITONEAL DRAINAGE SYSTEM (K093796)Pfm Medical, Inc.2010-02-26
ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K093592)Taidoc Technology Corporation2010-02-25
BINDER INTERVERTEBRAL BODY FUSION DEVICE (K093015)Binder Biomedical, Inc.2010-02-25
ITG VASCULAR ACCESS SYSTEM, MODEL 300 (K091006)Arstasis, Inc.2010-02-25
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES (K093741)Trek Diagnostic Systems, Ltd.2010-02-25
VISION SCIENCES FLEXIBLE ENT SCOPE (K100125)Vision-Sciences, Inc.2010-02-25
ENSITE VELOCITY SYSTEM V1.3 (K093942)St Jude Medical2010-02-25
VERSAPULSE MODEL P20 LASER SYSTEM (K100228)Lumenis, Inc.2010-02-24
DD BIO Z AND DD BIO Z - TRANSPA (K093748)Dental Direkt of Amerika UG (Haftungsbeschraenkt)2010-02-24
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA (K093425)Mako Surgical Corp.2010-02-24
STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS (K090068)Case Medical, Inc.2010-02-24
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (K093026)Footprint Medical2010-02-24
UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; (K091612)Ucp Biosciences, Inc.2010-02-24
GYRUS ACMI PK BUTTON ELECTRODE (K093181)Gyrus Acmi, Inc.2010-02-24
POWERPUMP ARTHROSCOPY SYSTEM (K093409)Medical Vision AB2010-02-24
CL-DC20, CL-DC21 (K093751)Good Doctors Co., Ltd.2010-02-24
FLEXIMARC, MODEL CM-0.9-2-10-GG-L (K100267)Cortex Manufacturing, Inc.2010-02-24
TRAXCESS DOCKING WIRE (K093647)MicroVention, Inc.2010-02-24
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (K091766)Binax, Inc.2010-02-24
CLAYTON INTRA-AURAL DEVICE (CID) (K091880)Ascentia Health Incorporated2010-02-24
BASESENS BLOOD GLUCOSE MONITORING SYSTEM (K093475)Hygeia, Inc.2010-02-24
LUBREASE FEMALE LUBRICANT (K091298)Curves Limited2010-02-24
12SL ECG ANALYSIS PROGRAM (K092369)Ge Medical Systems Information Technologies2010-02-24
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM (K092894)Eps Bio Technology Corp.2010-02-24
SKIN BARRIER FILM (K092712)Lodestar Products, Inc.2010-02-23
MEP-90 HAIR GROWTH STIMULATION SYSTEM (K091496)Midwest Rf, LLC2010-02-23
SYNGO.PET&CT ONCOLOGY (K093621)Siemens Medical Solutions USA, Inc.2010-02-23
CORVUS RADIATION THERAPY PLANNING SYSTEM (K100092)Best Nomos2010-02-23
ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 (K093086)Orthodynamix, LLC2010-02-23
AESKULISA MPO, MODEL 30-7303US (K091860)Aesku Diagnostics2010-02-23
SAS FLUALERT A&B, SAS INFLUENZA A TEST (K100227)Sa Scientific, Inc.2010-02-23
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK (K093653)Uresil, LLC2010-02-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K093798)Supermax Plastic Products Co., Ltd.2010-02-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) (K093797)Supermax Plastic Products Co., Ltd.2010-02-23
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K092681)Khai Hoan Joint Stock Company2010-02-23
TIDI FACEMASK (K092580)Tidi Products,Llc2010-02-23
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 (K100107)Smith & Nephew, Inc.2010-02-23
CAPILLARYS NEONAT HB (PN 2006) (K091283)Sebia2010-02-22
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 (K093718)Zutron Medical, LLC2010-02-22
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K093726)Medline Industries, Inc.2010-02-22
BACT-TRAP HEPA MIDI (K093426)Pharma Systems AB2010-02-22
NATUS NEUROWORKS, MODEL 104196 (K090019)Natus Medical, Inc.2010-02-22
POGO SCREW INSTRUMENTATION TRAY (K091806)Fxdevices2010-02-22
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 (K100380)Pari Respiratory Equipment, Inc.2010-02-22
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR (K092144)Endochoice, Inc.2010-02-22
INTOUCH DIABETES (K093789)Symcare Personalized Health Solutions, Inc.2010-02-19
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY (K100209)Becton, Dickinson & CO2010-02-19
HAMMERLOCK (K091951)Biomedical Ent., Inc.2010-02-19
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS (K100197)Smith & Nephew, Inc.2010-02-19
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K090917)Baxa Corp.2010-02-19
COSP2 (K093721)3M Espe AG Dental Products2010-02-19
FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM (K093712)Taidoc Technology Corporation2010-02-19
OSCAR 3 (K093805)Orthosonics, Ltd.2010-02-19
NUVASIVE HELIX REVOLUTION ACP SYSTEM (K093804)Nuvasive, Inc.2010-02-19
ACCELERATOR APS (K093318)Abbott Laboratories2010-02-19
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Every clearance here is in the API, with alerts when new ones post.