Atlas FDA

2007

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

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RecordFirmDate
SUTRALENE POLYPROPYLENE SUTURES (K070243)Visionary Medical Supplies, Inc.2007-04-17
REVOLIX DUO LASER SYSTEM (K070466)Allmed Systems, Inc.2007-04-17
SPI VECTODRILL CERAMIC DRILLS (K070290)Thommen Medical AG2007-04-17
CYRTINA SYSTEM (K063842)Oratio B.V.2007-04-17
XPERT MRSA (K070462)Cepheid2007-04-17
LINDE INTEGRATED VALVE (LIV) (K063354)Linde Gas Therapeutics2007-04-17
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K070172)Roche Diagnostics Corporation2007-04-17
ULTRAPRO PLUG (K070224)ETHICON, Inc.2007-04-17
HEALTH MASK (K070467)Polar Wrap, LLC2007-04-17
INTERSON USB ULTRASOUND PROBE SYSTEM (K070907)Regulatory Management Services2007-04-17
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS (K060915)Kirwan Surgical Products, Inc.2007-04-17
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 (K063306)Alfa Wassermann, Inc.2007-04-17
KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 (K062453)Kingly Star Intl. Technology Co., Ltd.2007-04-17
INQU (K063359)Isto Technologies, Inc.2007-04-16
MICROBLADE SHAVER AND ACCESSORIES (K063231)Baxano, Inc.2007-04-16
ABBOTT ARCHITECT HAVAB-M (K063329)Abbott Laboratories2007-04-16
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION (K070125)Baxter Healthcare Corp2007-04-16
NANO COMPOSITE (K070583)Cosmedent, Inc.2007-04-16
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE (K070227)Arthrocare Corp.2007-04-16
MEISINGER BENEX, MODEL BE001 (K062130)Hager& Meisinger GmbH2007-04-16
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM (K063790)Synthes (Usa)2007-04-16
EXPRESS SERIES (K070858)Medical Graphics Corp.2007-04-16
ODONCER (K062102)Teknimed, S.A.2007-04-16
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174)Roche Diagnostics Corporation2007-04-16
LIFT CHAIR, MODEL C5 (K070950)Pride Mobility Products Corp.2007-04-16
DYE MANAGEMENT SYSTEM (K063784)Icu Medical, Inc.2007-04-16
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING (K063271)Convatec, A Division of E.R. Squibb & Sons, LLC2007-04-16
SIMPLEX CERVICAL FIXATION SYSTEM (K070335)Pisharodi Surgicals, Inc.2007-04-16
POLARCUP DUAL MOBILITY SYSTEM (K070278)Plus Orthopedics AG2007-04-16
AUDICOR 200 SYSTEM, MODELS 200D AND 200S (K070136)Inovise Medical, Inc.2007-04-13
ARTHROCARE SPINEWANDS (K070851)Arthrocare Corp.2007-04-13
ANTLIA II SUCTION PUMP SYSTEM (K070904)Innovative Therapies, Inc.2007-04-13
DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B (K063071)Kyphon, Inc.2007-04-13
DGSCOPE, RELEASE 1.0 (K070397)Segami Corporation2007-04-13
LERADOTECH SCOOTER, MODEL SB (K070817)Lerado China Limited2007-04-13
MODIFICATION TO STAXX FX SYSTEM (K063606)Spine Wave, Inc.2007-04-13
LERADOTECH, MODEL SC (K070802)Lerado China Limited2007-04-13
FLEXITRON (K070574)Isodose Control B.V.2007-04-13
STARION UNIVERSAL POWER SUPPLY (K070871)Starion Instruments2007-04-13
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K062526)Multisafe Sdn. Bhd.2007-04-13
VAPOTHERM MODEL# 2000I AND 2000H (K070056)Vapotherm, Inc.2007-04-13
MULTI-ANALYTE CHEMISTRY CALIBRATOR (K070207)Pointe Scientific, Inc.,2007-04-13
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 (K062449)E-Z-Em, Inc.2007-04-13
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS (K070745)Playtex Products, Inc.2007-04-13
MODIFICATION TO: BODYGUARD INFUSION SYSTEM (K070718)Caesarea Medical Electronics , Ltd.2007-04-13
TEPHAFLEX SURGICAL MESH (K070894)Tepha, Inc.2007-04-13
FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) (K063125)Arc Medical, Inc.2007-04-13
RS-4I MUSCLE STIMULATOR FAMILY (K062325)Rs Medical2007-04-13
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS (K062362)Sarmed Srl2007-04-13
SMS GLUCOSE CONTROL, MODEL 2120061 (K070649)Spectrum Medical Supply, Inc.2007-04-12
GC MI PASTE PLUS (K070854)GC America, Inc.2007-04-12
OMEGA 3 SUPRACONDYLAR PLATE (K070454)Howmedica Osteonics Corp.2007-04-12
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N (K061896)Mediaid, Inc.2007-04-12
OSTEOFIX BONE VOID FILLER (K070220)Calcitec, Inc.2007-04-12
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K070367)Endius, Inc.2007-04-12
MIRAGE CEDARS OPTION (K070683)Segami Corporation2007-04-12
ENDOBUTTON DIRECT (K070167)Smith & Nephew Inc., Endoscopy Division2007-04-12
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 (K062473)DiaSorin, Inc.2007-04-12
BIODUCT (K053492)Bioduct, LLC2007-04-12
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING (K061277)Straumann USA2007-04-12
MYOMO E100 (K062631)Myomo, Inc.2007-04-12
AMMONIA/ALCOHOL CONTROL SET (K070504)Pointe Scientific, Inc.,2007-04-11
POD B-SCAN (K070884)Starfish Product Engineering, Inc.2007-04-11
ASC-12 PIEZOELECTRIC SCALER (K070866)Aseptico, Inc.2007-04-11
POWDERED LATEX SURGICAL GLOVE (K062797)Beijing Reagent Latex Products Co., Ltd.2007-04-11
TRIAL CABLE, 3009 (K070847)Advanced Neuromodulation Systems2007-04-11
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F (K070782)Survivair Respirators, LLC2007-04-11
QUANTA LITE RNA POL III ELISA (K070066)Inova Diagnostics, Inc.2007-04-11
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR (K070674)Trudell Medical Intl.2007-04-11
NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL (K070778)Neocoil2007-04-11
HYPERVISOR VI CENTRAL MONITORING SYSTEM (K062194)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-04-11
EP-WORKMATE (K070706)Ep Medsystems2007-04-11
TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701)Teco Diagnostics2007-04-11
STATIC CRANIOPLASTY ORTHOSIS (K063098)Boston Brace Intl., Inc.2007-04-11
EXPEDIUM SFX CROSS CONNECTOR SYSTEM (K070300)Depuy Spine, Inc.2007-04-10
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM (K070813)Medison Co., Ltd.2007-04-10
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. (K063542)Mesure Technology Co., Ltd.2007-04-10
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM (K070850)Abbott Diabetes Care, Inc.2007-04-10
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES (K070519)Zhang Jia Gang Huayuan Plastic Co. , Ltd.2007-04-10
JMS PLANECTA STOPCOCK (K070143)Jms North America Corp.2007-04-10
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 (K070641)Taidoc Technology Corporation2007-04-09
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON (K070734)Diazyme Laboratories2007-04-09
RMI LCD ALCOHOL DETECTOR (K062545)Resource Management International, LLC2007-04-09
POWERED NITRILE BLUE EXAMINATION GLOVES (K061505)Liwe Trading2007-04-09
FOAM RING PORT PROTECTOR (K062261)Inspired Ideas, Incorporated2007-04-09
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS (K063720)Ortho-Clinical Diagnostics2007-04-09
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (K062862)Olympus America, Inc.2007-04-06
VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) (K070218)Vertiflex (Tm), Incorporated2007-04-06
MICRUS MICROCOIL SYSTEM (K070707)Micrus Endovascular Corporation2007-04-06
QLAB QUANTIFICATION (K070792)Philips Ultrasound, Inc.2007-04-06
COMBI SCAN100 (K061846)Analyticon Biotechnologies AG2007-04-06
STRADA CAROTID GUIDING SHEATH (K070166)St Jude Medical2007-04-06
KINESIA (K063872)Cleveland Medical Devices, Inc.2007-04-06
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM (K070051)Acumen Medical, Inc.2007-04-06
CHILI PACS (K070796)Chili GmbH2007-04-06
INVIVODENTAL (K070803)Anatomage, Inc.2007-04-06
MEDILOGAR4, MEDILOGAR12 (K070818)Tom Medical Entwicklungs GmbH2007-04-06
OPUS SMARTSTITCH SUTURE DEVICE (K070671)Arthrocare Corp.2007-04-06
HYPERQ SYSTEM (K070624)Biological Signal Processing, Ltd.2007-04-06
KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US (K063501)Mallinckrodt Developpement France2007-04-06
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Every clearance here is in the API, with alerts when new ones post.