Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WELMED HYPODERMIC SYRINGE (K070936)Welmed, Inc.2007-07-16
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) (K070299)Ezfit Technology, Inc.2007-07-16
VARISOURCE IX HDR AFTERLOADER (K071467)Varian Medical Systems, Inc.2007-07-16
SATURN 9000 (K063710)New Medical Co., Ltd.2007-07-16
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (K071494)Terumo Corp.2007-07-16
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM (K070500)Ni Medical2007-07-16
ROCHE ELECSYS PTH TEST SYSTEM (K070709)Roche Diagnostics Corp.2007-07-13
RESTRAXX DATA CENTRE, MODEL R10 (K070746)Resmed, Ltd.2007-07-13
BLUE MAX BALLOON DILATATION CATHETER (K071309)Boston Scientific Corp2007-07-13
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM (K070112)Medcool, Inc.2007-07-13
MOSAIC LASER SYSTEM (K070392)Lutronic Corporation2007-07-13
I-CHROMA CRP TEST (K062981)Boditech Diagnostics, Inc.2007-07-13
TRILOGY ANALYZER (K070704)Drew Scientific, Inc.2007-07-13
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION (K063069)Medical Molecular Therapuetics, LLC2007-07-13
TRIPORE, MODELS HA, BP90, BP15 (K070132)Orthogem Limited2007-07-13
AUTOVENT 4000 WITH CPAP (K070636)Allied Healthcare Products, Inc.2007-07-13
POWDER FREE LATEX EXAMINATION GLOVES (K071322)Quality Gallant Sdn. Bhd.2007-07-13
PC-60, NON-INVASIVEPULSE OXIMETER (K063641)Shenzhen Creative Industry Co., Ltd.2007-07-13
ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES (K070555)Orthopro, LLC2007-07-13
MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE (K071728)Surgrx, Inc.2007-07-13
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 (K063805)Nucryst Pharmaceuticals, Inc.2007-07-13
TRILOGY LONGEVITY CONSTRAINED LINER (K071718)Zimmer, Inc.2007-07-13
CUSTOMIZED SOUND THERAPY (CST) (K070599)Tinnitus Otosound Products, LLC2007-07-13
ON THE GO SHARPS (K070577)Medport, Inc.2007-07-13
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR (K070852)Shijiazhang Hongxiang Plastic Products Co., Ltd.2007-07-13
MEPILEX AG DRESSING (K071354)Monlycke Health Care2007-07-13
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (K071664)Bacchus Vascular, Inc.2007-07-13
POINTE 360 (K062118)Pointe Scientific, Inc.,2007-07-13
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT (K070183)Kronus Market Development Associates, Inc.2007-07-13
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 (K071721)Asahi Intecc Co., Ltd.2007-07-13
DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM (K070631)Stryker Spine2007-07-13
SILVER ALGINATE II WOUND DRESSING (K070581)Advanced Medical Solutions Limited2007-07-13
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM (K071640)Cook, Inc.2007-07-12
MODIFICATION TO:CONTOUR SE MICROSPHERES (K071634)Boston Scientific Corp2007-07-12
HONEY ALGINATE DRESSING (K053095)Derma Sciences Canada, Inc.2007-07-12
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 (K071473)Superdimension, Ltd.2007-07-12
DIGITAL PULSE OXIMETER, MODEL 7500 (K071285)Nonin Medical, Inc.2007-07-12
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER (K070578)Zen Strong Medical Technology Co., Ltd.2007-07-11
EASYGUIDE (K071599)Keystone Dental, Inc.2007-07-11
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 (K070611)Nomos Corp.2007-07-11
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (K071182)Nobel Biocare AB2007-07-11
DYNASTY ACETABULAR SYSTEM (K070785)Wrightmedicaltechnologyinc2007-07-11
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS (K071585)Straumann USA2007-07-11
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 (K071227)Spectranetics Corp.2007-07-11
ULTRAWAVE II EX 1320 (K070805)Quanta System Spa2007-07-11
AXYA SUTURE WELDING SYSTEM AND KIT (K070253)Axya Medical, Inc.2007-07-11
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM (K070960)Nova Biomedical Corp.2007-07-11
M2 MONITOR (K071725)Spectrum Medical , Ltd.2007-07-11
BACKPACK MEDICAL OXYGEN SYSTEM (K071581)Essex Cryogenics of Missouri, Inc.2007-07-11
GIRAFFE AND PANDA WARMER (K070377)Ohmeda Medical2007-07-11
TERUMO 31G THINPRO INSULIN SYRINGE (K071630)Terumo Medical Corp.2007-07-11
ENDO-CHX (K070401)Essential Dental Systems, Inc.2007-07-11
SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 (K070634)Soyee Product, Inc.2007-07-11
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (K063357)Greiner Bio-One North America, Inc.2007-07-10
BENVENUE VCF OSTEO COIL SYSTEM (K070293)Benvenue Medical, Inc.2007-07-10
HIGHPAK-12 (K062331)Ad Elektronik GmbH2007-07-10
ATLANTIK (K070794)Medical Biomat2007-07-10
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL (K070333)Acrymed, Inc.2007-07-10
FACIAL RECONSTRUCTIVE MESH (FRM) (K063154)Evera Medical, Inc.2007-07-10
VPAP AUTO WITH H3I (K071171)Resmed, Ltd.2007-07-10
PARIETEX POLYESTER MESH WITH INTRODUCER (K071629)Sofradim Production2007-07-10
EXPEDIUM SPINE SYSTEM (K063772)Depuy Spine, Inc.2007-07-10
QWIX POSITIONING SCREW (K071639)Newdeal Sas2007-07-09
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE (K071264)Synthes (Usa)2007-07-09
CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS (K071534)Confirma, Inc.2007-07-09
FL BOND II (K071452)Shofu Dental Corp.2007-07-09
BIOMET VISION FOOTRING SYSTEM (K071395)Biomet Manufacturing Corp2007-07-09
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER (K070732)Smiths Medical Pm, Inc.2007-07-09
HEXAPOD RT COUCH TOP (K071870)Medical Intelligence Medizintechnik GmbH2007-07-08
PILLAR PEDICLE SCREW SYSTEM (K071743)The 4th Column, LLC2007-07-06
SAPIMED DISPOSABLE SIGMOIDOSCOPE (K070915)Sapimed S.P.A.2007-07-06
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON (K071107)Zimmer, Inc.2007-07-06
MODIFICATION TO: STOCKERT S5 SYSTEM (K071318)Sorin Group Deutschland GmbH2007-07-06
AURORA LED SERIES SURGICAL LIGHTS (K071698)Skytron, Div. the Kmw Group, Inc.2007-07-06
WELLNESSPRO 2010 (K062616)Intelsource Group, Inc.2007-07-06
DIGITAL STEREOLOC II (K071542)Lorad, A Hologic Co.2007-07-05
LIFE LATCH SHARPS & BIOHAZARD CONTAINER (K071088)M&M Industries, Inc.2007-07-05
GE OEC ALTITUDE (K071717)Shimadzu Corp.2007-07-05
ATRICURE BIPOLAR SYSTEM (K043579)AtriCure, Inc.2007-07-05
CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000 (K070811)Dexco2007-07-05
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM (K070983)Olympus Medical Systems Corporation2007-07-05
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM (K070317)Zeus Scientific, Inc.2007-07-05
POWDER-FREE VINYL EXAMINATION GLOVES (K071022)Glormed Colombia S.A.2007-07-05
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT (K070663)A-Dec, Inc.2007-07-05
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 (K071113)Restorative Therapies, Inc.2007-07-05
PRESSIO ICP MONITORING SYSTEM (K062584)Sophysa SA2007-07-05
STIFFER COAXIAL MICRO-INTRODUCER KIT (K071574)Enpath Medical, Inc.2007-07-05
ARTHREX FIBERWIRE (K071622)Arthrex, Inc.2007-07-03
ZIMMER SEGMENTAL SYSTEM (K070978)Zimmer, Inc.2007-07-03
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100 (K062377)Medapps, Inc.2007-07-03
AOS UNIVERSAL CONECTING GUIDE TUBE (K062824)Alpha-Omega Services, Inc.2007-07-03
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 (K071253)Medtronic Vascular2007-07-03
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER (K071156)Sounmed, Inc.2007-07-03
LIQUICHEK TUMOR MARKER CONTROL (K071675)Bio-Rad Laboratories2007-07-03
MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER (K071155)Science For Biomaterials2007-07-03
MODIFICATION TO PALOMAR LUXIR HANDPIECE (K070298)Palomar Medical Technologies, Inc.2007-07-03
QUANTUM SPINAL SYSTEM (K070973)Pioneer Surgical Technology2007-07-03
LG SPERM FREEZING (K070689)Genx Intl., Inc.2007-07-03
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION (K063063)Medical Molecular Therapuetics, LLC2007-07-03
FLEX-NECK ARC CATHETER (K070730)Medigroup, Inc.2007-07-03
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Every clearance here is in the API, with alerts when new ones post.