Atlas FDA

2010

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

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RecordFirmDate
HASKAL TORQUE DEVICE (K100425)Elcam Medical Acal2010-06-17
GYRUS ACMI HALO PKS CUTTING FORCEPS (K100896)Gyrus Acmi, Inc.2010-06-17
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 (K100861)Optovue, Inc.2010-06-17
COROENT XLR STANDALONE SYSTEM (K100043)Nuvasive, Inc.2010-06-16
ROBINSON MEDSURG QUICKSCREW RACK (K093800)Robinson Medsurg, LLC2010-06-16
POLYBONE DENTAL (K092194)Kyung Won Medical Co., Ltd.2010-06-16
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 (K101119)Siemens Medical Solutions USA, Inc.2010-06-16
ASCENSION ANKLE FUSION PLATE SYSTEM (K100176)Ascension Orthopedics, Inc.2010-06-16
CHEVEUX DIODE LASER SYSTEM (K100893)Sandstone Medical Technologies, LLC2010-06-16
10 X 10 VISION (K091928)Bioptics, Inc.2010-06-16
UNIMOM ALLEGRO (K100929)Blue Egg CO2010-06-16
ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 (K101406)Medrad Interventional/Possis2010-06-16
CLEARPOINT SYSTEM (K100836)Surgivision, Inc.2010-06-16
COLLAWOUND ART (K093351)Collamatrix, Inc.2010-06-16
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 (K100815)Oxypulse2010-06-16
OLYMPIC BRAINZ MONITOR MODEL OBM70001 (K093949)Natus Medical, Inc.2010-06-16
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 (K101421)DePuy Orthopaedics, Inc.2010-06-15
OUCHLESS MODEL PN10114 (K093951)Occam Design2010-06-15
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 (K092638)Abbott Diabetes Care, Inc.2010-06-15
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 (K092107)Nidacon International AB2010-06-15
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY (K100366)Maxter Catheters2010-06-14
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 (K082102)Apollo Endosurgery, Inc.2010-06-14
UNITED STEM, PSA TYPE (K100981)United Orthopedic Corp.2010-06-14
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101341)Shijiazhuang Universal Channel Plastic Co., Ltd.2010-06-14
OTIS -C PLUS (K100604)Sciences ET Bio Materiaux (Sbm)2010-06-14
SUDOSCAN (K100233)Impeto Medical2010-06-14
CRYOCARE CS SURGICAL SYSTEM (K101333)Endocare, Inc.2010-06-14
TIDI FACEMASK (K100800)Tidi Products,Llc2010-06-14
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY (K101444)Surgical Devices, A Global Business Unit Tyco2010-06-14
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) (K090608)Minta Medical Limited2010-06-14
ORAL/ENTERAL SYRINGES (K100099)Philips Children'S Medical Ventures2010-06-14
BD DIRECTIGEN EZ FLU A+B ASSAY (K101529)Becton, Dickinson & CO2010-06-14
HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI (K094009)Halt Medical, Inc.2010-06-14
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (K100480)Vitaltec Corporation2010-06-11
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100429)Laboratoires Urgo2010-06-11
GENESIS DM MODEL: 6053000A1 (K101242)Honeywell Hommed, LLC2010-06-11
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100430)Laboratoires Urgo2010-06-11
FIBER ONE (K100746)American Medical Systems2010-06-11
PASR/QUIETNITE (K093340)Exact Supplies , Ltd.2010-06-11
PATIENT MONITOR, MODEL PM50 (K101127)Contec Medical System Co., Ltd.2010-06-11
BRAINLAB KNEE ARTHROSCOPY (K093118)Brainlab AG2010-06-11
ENSITE VELOCITY SYSTEM, MODEL EE3000 (K101419)St Jude Medical2010-06-11
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129)Ambu A/S2010-06-11
JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON (K101334)Pathway Medical Technologies, Inc.2010-06-11
G-FORCE PEEK SUTURE ANCHOR SYSTEM (K100630)Wrightmedicaltechnologyinc2010-06-11
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM (K101274)Maquet Cardiovascular, LLC2010-06-11
ELECSYS INSULIN CALCHECK 5 (K101075)Roche Diagnostics Corp.2010-06-11
PREVENA INCISION MANAGEMENT SYSTEM (K100821)Kci USA, Inc.2010-06-11
THE WATER LILY (K094022)Clearwater Products, LLC2010-06-11
GSP NEONATALGALT KIT, MODEL 3303-001U (K100101)Perkinelmer, Inc.2010-06-11
INRATIO/INRATIO2 TEST STRIPS (K092987)Biosite Incorporated2010-06-11
FLEXI-LITE (K101262)Pressure-Tech, Inc.2010-06-10
VIBRO-TRAC (K092731)Pneumex, Inc.2010-06-10
BLOOD PRESSURE METER, MODEL CH-4532 (K093931)Citizen Systems Japan Co., Ltd.2010-06-10
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES (K100137)Wrightmedicaltechnologyinc2010-06-10
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 (K093679)AtriCure, Inc.2010-06-10
RETRIEVE IMPLANT CEMENT (K101044)Parkell, Inc.2010-06-10
GUIDED GROWTH SYSTEM (K093442)Orthofix, Inc.2010-06-10
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) (K100772)Resmed, Ltd.2010-06-09
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297)Epocal, Inc.2010-06-09
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM (K100623)Aesculap Implant Systems2010-06-09
GRAFT DELIVERY SYSTEM MODEL SA-6115 (K100754)Micromedics, Inc.2010-06-09
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) (K093819)Arkray Factory USA, Inc.2010-06-09
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM (K100398)Standard Diagnostics, Inc.2010-06-09
SUCTION IRRIGATION ELECTRODES AND ADAPTERS (K100711)Encision, Inc.2010-06-09
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) (K093193)La Glove (M) Sdn. Bhd.2010-06-08
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY (K101008)Shantou Institute of Ultrasonic Instruments (Siui2010-06-08
VITAL SIGNS MONITOR-VSM 6000 SERIES (K101445)Welch Allyn, Inc.2010-06-08
LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30 (K100217)Mediana Co., Ltd.2010-06-08
GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I (K093729)Hemcon Medical Technologies Europe, Ltd.2010-06-08
A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200 (K101002)Healthstats International Pte. , Ltd.2010-06-08
PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE (K092967)Pathwork Diagnostics2010-06-08
THL1 LASER (K100509)Erchonia Corporation2010-06-08
FETAL MONITOR MODEL: BT-200T (K100885)Bistos Co., Ltd.2010-06-07
PANPAC HSG CATHETER SET (K092983)Panpac Medical Corporation2010-06-07
MODIFICATION TO SCINTRON IV (K101013)Miegmbh2010-06-07
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (K091845)Phadia US, Inc.2010-06-07
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (K100807)American Medical Systems, Inc.2010-06-07
SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009 (K093975)Pan Global Implant2010-06-04
MIS SYSTEM (K100605)Spine Wave, Inc.2010-06-04
ORION II (HEAVY DUTY 350 LBS AND 500 LBS) (K101277)Future Mobility Healthcare, Inc.2010-06-04
SLEEPRIGHT (K100545)Power Products, Inc.-Splintek2010-06-04
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES (K100708)Pioneer Surgical Technology2010-06-04
HANAROSTENT ESOPHAGUS (CCC) (K093537)M.I.Tech Co., Ltd.2010-06-04
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES (K093853)Nonin Medical, Inc.2010-06-04
BIODENTA DENTAL IMPLANT SYSTEM (K093630)Biodenta Swiss AG2010-06-03
HOTDOG MULTI FUNCTION CONTROLLER (K094056)Augustine Biomedical & Design, LLC2010-06-03
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE (K100546)Parkermedicalinc2010-06-03
BD INTIMA II CLOSED IV CATHETER (K100775)Becton Dickinson Infusion Therapy Systems, Inc.2010-06-03
ULTICARE DISPOSABLE PEN NEEDLES (K100812)Ultimed, Inc.2010-06-03
CARECENTER MD (K093211)Cardiac Science Corporation2010-06-03
SYLE SMARTIP (K100833)Osspray, Ltd.2010-06-03
AESKU PR3 (K091859)Aesku Diagnostics2010-06-03
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (K101297)Coloplast A/S2010-06-03
MODIFICATION TO HBS HEADLESS BONE SCREW (K101030)Biopro, Inc.2010-06-03
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT (K092667)Genx Intl., Inc.2010-06-03
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 (K093102)Nihon Seimitsu Sokki Co., Ltd.2010-06-03
HYDROFIX SURGICAL SHEET (K100905)Mimedx Group, Inc.2010-06-02
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 (K101221)Pathway Medical Technologies, Inc.2010-06-02
MALTA (K100756)3M Espe AG Dental Products2010-06-02
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Track 2010 automatically

Every clearance here is in the API, with alerts when new ones post.