Atlas FDA

2010

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

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RecordFirmDate
SCOUTPRO HEMOSTATIC VALVE (K101282)Biotronik, Inc.2010-07-21
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 (K101232)Joinsoon Electronics Mfg Co, Ltd.2010-07-21
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 (K100766)Ion Beam Applications S.A.2010-07-21
GIRAFFE OMNIBED (K101788)Ohmeda Medical2010-07-21
SUPRA SCAN DELIVERY SYSTEM (K100678)Quantel Medical2010-07-21
GLIDESHEATH (K102008)Terumo Medical Corp.2010-07-21
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- (K101596)Kimberly-Clark2010-07-21
SARGON NON-EXPANDABLE DENTAL IMPLANT (K082573)Sargon Ent., Inc.2010-07-21
NES REPROCESSED VARICOSE VEIN RF CATHETER (K090661)Northeast Scientific, Inc.2010-07-21
CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION (K100986)Skeletal Kinetics, LLC2010-07-20
GALLERY LAMINOPLASTY FIXATION SYSTEM (K100805)Biomet Spine (Aka Ebi, LLC)2010-07-20
SOPIX 2 (K092329)Sopro2010-07-20
STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS (K100702)Huot Instruments, LLC2010-07-20
AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM (K100802)Aesculap Implant Systems, Inc.2010-07-20
COHEN CROSSOVER CATHETER (K101625)Vascular Solutions, Inc.2010-07-19
DIRECT PERORAL CHOLANGIOSCOPY BALLOON (K101095)Wilson-Cook Medical, Inc.2010-07-19
FIXPINE II SYSTEM (K100765)Dio Medical Co., Ltd.2010-07-19
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM (K101455)Medison Co., Ltd.2010-07-19
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (K100031)Ind Diagnostic, Inc.2010-07-19
LEV-OR DILATION CATHETER OTW (K101117)Baylis Medical Co., Inc.2010-07-16
LASEMAR 800, 1000, 1500 (K092860)Eufoton S.R.L.2010-07-16
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101840)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101841)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
ASTRASONIC SPIROMETER, MODEL 29-8000 (K092813)Sdi Diagnostics, Inc.2010-07-16
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES (K101108)Erbe USA, Inc.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100964)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-07-16
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE (K101102)Best Putra Gloves Sdn Bhd2010-07-16
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM (K093784)Zeus Scientific, Inc.2010-07-16
WATER BOTTLE CAP SYSTEM (K101146)United States Endoscopy Group, Inc.2010-07-16
REPROCESSED RESTEP COMPRESSION SLEEVES (K101087)Ascent Heatlhcare Solutions2010-07-16
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 (K101103)Best Putra Gloves Sdn Bhd2010-07-16
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (K101092)Medivance, Inc.2010-07-16
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) (K100611)Riverstone Resources Sdn Bhd2010-07-16
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K100603)Riverstone Resources Sdn Bhd2010-07-16
SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM (K092713)Transamerican Medical Imaging2010-07-16
JULIET OL (K101720)Spineart2010-07-16
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) (K100752)Ultradent Products, Inc.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101343)Shijiazhuang Star Plastic Co., Ltd.2010-07-16
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM (K101829)Medison Co., Ltd.2010-07-16
MEDIWORKS SLIT LAMP (K100439)Shanghai Mediworks Precision Instruments Co. , Ltd.2010-07-16
EVGUIDE TIP LOCATION SYSTEM (K093775)Romedex International Srl2010-07-15
VIVATRAK (K101109)Wireless Medcare, LLC2010-07-15
YEAST TRAFFIC LIGHT PNA FISH (K093024)Advandx, Inc.2010-07-15
VENTRALIGHT ST MESH (K101851)Davol Inc., Sub. C. R. Bard, Inc.2010-07-15
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 (K101252)Neotract, Inc.2010-07-15
PACSMATE MMD-5201M MONITOR (K101796)Iei Technology Corp.2010-07-15
FACET SCREW SYSTEM (K101284)Nuvasive, Inc.2010-07-15
XINIWAVE, MODEL XW-18 (K100441)International Trade Group, Inc.2010-07-15
LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE (K100109)Surgical Innovations Plc2010-07-15
OPTOS LIMITED PANORAMIC 200CAF (K100644)Optos Plc.2010-07-15
FLAT PANEL DETECTOR, MODEL FDR D-EVO (K100762)Fujifilm Medical Systems U.S.A, Inc.2010-07-15
THD BANDY (K093497)Thd Spa2010-07-15
SMITH & NEPHEW MDF MODULAR SLEEVE (K100481)Smith & Nephew, Inc.2010-07-15
REMEL SPECTRA VRE (K092819)Thermo Fisher Scientific2010-07-15
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM (K101254)Tecnologia Y Diseno Industrial, S.A DE C.V2010-07-15
ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (K093903)Genesee Biomedical, Inc.2010-07-15
DENTLIGHT ORAL EXAM LIGHT KIT (K101140)Dentlight, Inc.2010-07-15
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 (K100066)Welldoc, Inc.2010-07-15
DISPOSABLE REFLECTIVE MARKER SPHERES (K100038)Brainlab AG2010-07-14
OLYMPUS CF TYPE Y0023-L, Y0023I (K101053)Olympus Medical Systems Corporation2010-07-14
ENSITE VELOCITY SYSTEM (K101328)St Jude Medical2010-07-14
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION (K093648)Simplisse, Inc.2010-07-14
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) (K093179)H&H Research Company2010-07-14
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 (K101858)Shanghai Chenguang Medical Technologies Co, Ltd.2010-07-14
AESCULAP MONOMAX ABSORBABLE SUTURE (K100876)Aesculap, Inc.2010-07-14
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY (K101735)Angioscore, Inc.2010-07-14
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT (K100360)Cochlear Americas2010-07-13
VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890)Varian Medical Systems2010-07-13
MODEL 300157 CPAP SYSTEM (K100121)Aeiomed, Inc.2010-07-13
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950)Venner Medical (Singapore) Pte, Ltd.2010-07-13
PENUMBRA CATHERER 025 (K100826)Penumbra, Inc.2010-07-13
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS (K101570)Micro Therapeutics Dba Ev3 Neurovascular2010-07-13
PTA-DUO PTA BALLOON CATHETER (K101047)Hotspur Technologies2010-07-13
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM (K093262)Andon Medical Co., Ltd.2010-07-13
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 (K101703)Card Guard Scientific Survival , Ltd.2010-07-13
ASCENSION ANKLE FUSION NAIL SYSTEM (K100925)Ascension Orthopedics, Inc.2010-07-12
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (K101059)Omega Laboratories, Inc.2010-07-12
EMBO PLUS EMBOLECTOMY CATHETER (K100840)Hotspur Technologies2010-07-12
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE (K093910)Guangzhou Improve Medical Instruments Co., Ltd.2010-07-12
SAVI PREPARATION DEVICE (K101411)Cianna Medical, Inc.2010-07-12
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM (K100842)Hotspur Technologies2010-07-12
VARIAN TREATMENT (K093967)Varian Medical Systems, Inc.2010-07-12
MD2000B VITAL SIGN MONITOR, MODEL MD2000B (K100740)Beijing Choice Electronic Technololgy Co., Ltd.2010-07-09
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 (K100732)Taidoc Technology Corporation2010-07-09
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K101651)Cordis Corp.2010-07-09
LOCI 8 CALIBRATOR, MODEL KC 646 (K101460)Siemens Healthcare Diagnostics2010-07-09
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM (K100647)A-Dec, Inc.2010-07-09
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818)Meridian Bioscience, Inc.2010-07-09
SPONDY SPINAL FIXATION SYSTEM (K100956)Allure Spine LLC2010-07-09
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM (K100658)Taidoc Technology Corporation2010-07-09
PULMOTRACK 5050 WHOLTER, MODEL 5050 (K101022)Karmelsonix2010-07-09
ECLERIS MICROSTAR COLPOSCOPE (K100595)Ecleris USA2010-07-09
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES (K101680)Welch Allyn, Inc.2010-07-09
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER (K100428)Masimo Corporation2010-07-09
FIL 1520 (K101629)Glenn Medical Systems, Inc.2010-07-09
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL (K100907)Siam Sempermed Corp., Ltd.2010-07-09
VENOFER PUMP (K093964)Renal Solutions, Inc.2010-07-09
COTEC DENTAL IMPLANT SYSTEM (K100511)Cotec Implant Co., Ltd.2010-07-09
BD DIRECTIGEN EZ RSV (K101514)Becton, Dickinson & CO2010-07-09
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Every clearance here is in the API, with alerts when new ones post.