Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST (K083294)Nanosphere, Inc.2009-07-24
BENACEL (K090612)Unicare Biomedical2009-07-24
ELATION MB METAL REINFORCED PLASTIC BRACKET (K092030)Dentsply Interntional2009-07-24
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 (K090646)Chest M.I., Inc.2009-07-23
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) (K091421)Novapro Co., Ltd.2009-07-23
IONOLUX (K090817)Voco GmbH2009-07-23
VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN (K091586)Medcomp2009-07-23
INSUFLOW CO2IONSHIELD (K090879)Lexion Medical, LLC2009-07-23
SOLO INSULIN PATCH PUMP (K090245)Medingo , Ltd.2009-07-23
UNIVERSAL, AESTHETICA, NATEA, NATURA (K083670)Euroteknika2009-07-23
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 (K091300)CAO Group, Inc.2009-07-23
TEMPORARY C&B COMPOSITE (K091894)Voco GmbH2009-07-23
OMNI 5 TOTAL O2 DELIVERY SYSTEM (K091028)Respironics, Inc.2009-07-23
SAS INFLUENZA A & B TEST (K080380)Sa Scientific, Inc.2009-07-23
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (K090766)Lifeloc Technologies, Inc.2009-07-23
GCUC-505 (K091388)GC America, Inc.2009-07-22
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER (K091832)Endogastric Solutions, Inc.2009-07-22
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE (K090406)Interacoustics AS2009-07-22
VINYL POWDER FREE EXAMINATION GLOVE (K091429)Shun DA (Xinghua) Co., Ltd.2009-07-22
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003 (K090485)Percutaneous Systems, Incorporated2009-07-22
POWDERED VINYL PATIENT EXAMINATION GLOVES (K082647)Tangshan Dar Plastic & Rubber Products Co. , Ltd.2009-07-22
ADKINS STRUT (K091058)Biomet Microfixation, Inc.2009-07-22
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 (K090902)Transenterix, Inc.2009-07-22
ALATECH POWDER FREE LATEX EXAMINATION GLOVE (K083761)Alatech Healthcare, LLC2009-07-22
CONQUEST SPINAL SYSTEM (K090320)Life Spine2009-07-22
VINYL POWDER FREE EXAMINATION GLOVE (K091383)Shun Tong Co., Ltd.2009-07-22
ACTICOAT FLEX 7 DRESSING (K083113)Smith & Nephew, Inc.2009-07-22
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 (K091355)Conmed Endoscopic Technologies, Inc.2009-07-22
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 (K091264)Siemens Healthcare Diagnostics2009-07-22
NUVASIVE SPHERX II SYSTEM (K091502)Nuvasive, Inc.2009-07-22
IMPLANT CENTER 2 (K091252)Satelec2009-07-22
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST (K091163)Fiab Spa2009-07-22
QXLINK (K092081)Vieworks Co., Ltd.2009-07-21
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM (K091075)iRhythm Technologies, Inc.2009-07-21
GOLD ANCHOR (K091645)Naslund Medical AB2009-07-21
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP (K090830)Laborie Medical Technologies, Ltd.2009-07-21
EZ HSG CATHETER.FOAMSEAL CATHETER (K083594)Obg Products2009-07-21
PARI PEP S (K090829)Pari Respiratory Equipment, Inc.2009-07-21
BOLUS COMPENSATOR (K091911).Decimal, Inc.2009-07-21
STIMULUS/DISSECTION INSTRUMENTS (K090838)Axon Systems, Inc.2009-07-20
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (K082982)Breathe Technologies, Inc.2009-07-20
DRX-EVOLUTION, MODEL VX3733-SYS (K091889)Carestream Health, Inc.2009-07-20
VINYL POWDERED EXAMINATION GLOVE (K091384)Shun Tong Co., Ltd.2009-07-20
FLORASEAL, MODEL FS350D (K083354)Adhezion Biomedical2009-07-20
LEKSELL GAMMAPLAN (K090972)Elekta Instrument AB2009-07-20
PERFSCAPE (K091444)Olea Medical2009-07-20
MD300K1 PULSE OXIMETER (K090599)Beijing Choice Electronic Technololgy Co., Ltd.2009-07-20
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) (K091760)Dermaport, Inc.2009-07-20
PROGENY VANTAGE PANORAMIC X-RAY SYSTEM (K091866)Midmark2009-07-20
CHROMID MRSA AGAR, MODEL: REF 43 841 (K091024)bioMerieux, Inc.2009-07-17
ADHESE ONE F (K090941)Ivoclar Vivadent, Inc.2009-07-17
CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS (K091804)Philips Ultrasound, Inc.2009-07-17
STARLIGHT (K090587)Orthomerica Products, Inc.2009-07-17
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES (K090734)Medica Corp.2009-07-17
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 (K091296)Polymap Wireless2009-07-17
OPTIMA MR450W (K091536)Ge Medical Systems, LLC2009-07-17
SYNGO VOLUME PERFUSION-CT BODY (K092013)Siemens AG Medical Solutions2009-07-17
QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (K091617)Thermo Fisher Scientific2009-07-17
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM (K091558)Bioptics, Inc.2009-07-17
MONACO RTP SYSTEM, VMAT OPTION (K091179)Computerized Medical Systems, Inc.2009-07-16
SMITH & NEPHEW RF CANNULATE (K090955)Smith & Nephew, Inc.2009-07-16
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 (K092088)Pride Mobility Products Corp.2009-07-16
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE (K091900)Covidien Lp, Formerly Registered AS United States2009-07-16
SILENT SLEEP (K082849)Craniofacial Pain Center of Idaho2009-07-16
SQ IS SYSTEM (K090825)Neobiotech Co., Ltd.2009-07-16
AKLARUS PHOTOTHERAPY SYSTEM (K083183)Hill Laboratories Co.2009-07-16
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E (K090914)Xoft, Inc.2009-07-16
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 (K083419)Actherm, Inc.2009-07-16
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 (K083903)3M Company2009-07-15
PASCAL PHOTOCOAGULATOR, PASCAL-US (K091666)Optimedica Corporation2009-07-15
SONICAID FM820 AND FM830 ENCORE (K090285)Huntleigh Healthcare , Ltd.2009-07-15
TRIMED STERILE PRODUCT (K091156)TriMed, Inc.2009-07-15
PASSPORT V MONITOR, MODEL 0998-00-6100 (K091834)Datascope Corp., Patient Monitoring Division2009-07-15
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 (K091008)Sorin Group Deutschland GmbH2009-07-15
CD HORIZON SPINAL SYSTEM (K091442)Medtronic Sofamor Danek2009-07-15
MODIFICATION TO MEDICOMPASS CONNECT (K091021)Imetrikus, Inc.2009-07-15
TALOS INTERVERTEBRAL BODY FUSION DEVICE (K090707)Meditech Advisors, LLC2009-07-15
TIGRT TPS (K090893)Linatech, LLC2009-07-15
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS (K083912)Treu-Instrumente GmbH2009-07-15
NUTRAC PELVATOR, MODEL PEL 200 (K083704)Verity Scientific , Ltd.2009-07-14
WATERLASE C100, MODEL 7100104 (K091922)Biolase Technology, Inc.2009-07-14
ZYFUSE FACET FIXATION SYSTEM (K090952)Globus Medical, Inc.2009-07-14
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP (K091751)DePuy Orthopaedics, Inc.2009-07-14
5.5 POLARIS SPINAL SYSTEM (K091067)Biomet Spine2009-07-14
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM (K090389)Bestgen Biotech Corp.2009-07-14
PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 (K090655)Source-Ray, Inc.2009-07-14
RALCO, MODEL R225 ACS (K091517)Ralco S.R.L.2009-07-14
MINITAPE URETHRAL SLING (K091180)Mpathy Medical Devices, Ltd.2009-07-14
SINUS QUICK IT SYSTEM (K090527)Neobiotech Co., Ltd.2009-07-14
VALOR ANKLE FUSION NAIL SYSTEM (K090857)Wrightmedicaltechnologyinc2009-07-14
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM (K091088)Ldr Spine USA2009-07-14
CORONIS 5MP HD, MODEL MDMG 5121 (K091274)Barco N.V.2009-07-14
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222 (K090188)Taidoc Technology Corporation2009-07-13
APTUS FOOT SYSTEM (K091479)Medartis AG2009-07-13
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 (K091153)Beckman Coulter, Inc.2009-07-13
M3 MONITOR (K091908)Spectrum Medical , Ltd.2009-07-10
GMK TOTAL KNEE SYSTEM (K090988)Medacta International S.A.2009-07-10
NEWDEAL HALLU LOCK PLATE SYSTEM (K083154)Newdeal Sas2009-07-10
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K083712)Dipure, LLC2009-07-10
COOK UROLOGICAL GRAFT (K090688)Cook Biotech, Inc.2009-07-10
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Every clearance here is in the API, with alerts when new ones post.