Atlas FDA

2013

3,052 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MFP-051 (K123631)GC America, Inc.2013-07-23
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (K130862)Dentsply Intl., Inc.2013-07-23
ULTRAEXTEND USWS-900A V2.1 AND V3.1 (K131822)Toshiba America Medical Systems, In.C2013-07-23
NIGHTINGALE MONITORING SYSTEM (K130740)Zoe Medical, Inc.2013-07-23
AIRSONETT AIR-4 (K130702)Airsonett AB2013-07-23
FORUM GLAUCOMA WORKPLACE (K130648)Carl Zeiss Meditec, AG2013-07-23
MICRO AMBULATORY ECG RECORDER (K131572)Dimetek Digital Medical Technologies, Ltd.2013-07-22
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS (K131191)Depuy Mitek, A Johnson & Johnson Company2013-07-22
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K131306)Bio Compression Systems, Inc.2013-07-22
RHYTHMIA MAPPING SYSTEM (K130750)Rhythmia Medical, Inc.2013-07-22
MR CONDITIONAL PRESSON ELECTRODE (K130220)Rhythmlink International, LLC2013-07-22
GRAM-NEGATIVE QUICKFISH BC (K123418)Advandx, Inc.2013-07-21
IHEALTH CLOUD (K131203)Andon Health Co, Ltd.2013-07-19
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, (K130136)Technomed Europe2013-07-19
KLOCKNER DENTAL IMPLANT ABUTMENTS (K122988)SOADCO, S.L.2013-07-19
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (K131332)Cardiosolutions, Inc.2013-07-19
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS (K131811)Ucp Biosciences, Inc.2013-07-19
ELIXBO PM545 (K130658)Xbo Medical Systems Co., Ltd.2013-07-19
NAVIGATION PIN (K131130)Evergreen Orthopedic Research Lab2013-07-19
T1040 AKA AURAWAVE (K124055)Endurance Therapeutics2013-07-19
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW (K130731)Stabiliz Orthopaedics, LLC2013-07-19
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (K130068)Essex Industries, Inc. D/B/A Essex Cryogenics of M2013-07-19
TRANSCEND (K120510)Syneron Medical, Ltd.2013-07-19
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER (K130079)Reflectance Medical, Inc.2013-07-19
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K131467)Conformis, Inc.2013-07-18
ICT (K130224)Imris, Inc.2013-07-18
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) (K131137)Jvckenwood Corporation2013-07-18
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 (K131776)Randox Laboratories, Ltd.2013-07-18
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179)Thoratec Corp2013-07-18
NAOMI-CT (K123332)Lk Consulting Group2013-07-18
CERTUS 140 CERTUSURGGT SURGICAL TOOL (K130399)Neuwave Medical, Inc.2013-07-18
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (K131327)Bio Compression Systems, Inc.2013-07-18
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM (K130088)Genoray Co., Ltd.2013-07-18
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K131688)Neosurgical, Ltd.2013-07-18
INPULSE LASER (K131805)Incisive, Inc.2013-07-18
SOLID GEL PAD (K131905)Bluemtech2013-07-18
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) (K131046)Venous Health Systems, Inc.2013-07-18
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE (K130766)Cook, Inc.2013-07-17
ENDOFLIP CATHETER (K130906)Crospon, Ltd.2013-07-17
GREENCROSS SURGICAL MASK (K123787)Jingzhou Haixin Green Cross Medical Products Co.,L2013-07-17
25-OH VITAMIN D ELISA (K123660)Euroimmun US2013-07-17
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE (K130083)Demetech Corp.2013-07-17
IMDX VANR FOR ABBOTT M2000 (K123753)Intelligent Medical Devices, Inc.2013-07-17
ACRYLIC HERBST APPLIANCE (K113126)Gergens Orthodontic Lab2013-07-17
VALUTRODE NEUROSTIMLATION ELECTRODES (K130987)Axelgaard Mfg. Co., Ltd.2013-07-17
LIFE SPINE PLATEAU SPACER SYSTEM (K131077)Life Spine2013-07-17
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER (K131853)Mentor Worldwide, LLC2013-07-17
COBAS C BILIRUBIN TOTAL GEN.3 (K131544)Roche Diagnostics2013-07-17
EXPORT ADVANCE ASPIRATION CATHETER (K130536)Medtronic, Inc.2013-07-16
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM (K131120)STERIS Corporation2013-07-16
LPP (LOW PROFILE PORT) (K122402)Pfm Medical, Inc.2013-07-16
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K131434)Visionsense, Ltd.2013-07-16
HERMES MEDICAL IMAGING SUITE V5.3 (K131233)Hermes Medical Solutions AB2013-07-16
UNIVERSAL OPAQUE (K131504)Shofu Dental Corporation2013-07-16
BD PEN NEEDLE (K131358)Becton, Dickinson & CO2013-07-16
RADVISION (K131428)Acoustic Medsystems, Inc.2013-07-16
ANA SCREEN ELISA (IGG) (K131185)Euroimmun US2013-07-15
EXTAVIPRO STERICAN 30G (K131040)B.Braun Melsungen AG2013-07-15
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE (K130657)All Medicus Co., Ltd.2013-07-15
25OH VITAMIN D TOTAL ELISA TEST (K123364)Diasource Immunoassays, S.A.2013-07-15
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (K130253)Beckman Coulter, Inc.2013-07-15
DENTEK EASY BRUSH WITH FLUORIDE (K130186)Den Tek Oral Care, Inc.2013-07-15
NEOTIS; NEOTIS 50 (K130953)Sbm Sciences For Bio Materials2013-07-15
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K130585)VATECH Co., Ltd.2013-07-15
NEBA SYSTEM (DEN110019)Lexicor Medical Technology, LLC2013-07-15
TRUSCOPE SERIES PATIENT MONITOR (K131763)Guangdong Biolight Meditech Co., Ltd.2013-07-15
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION (K130360)Constant Care, LLC2013-07-15
611 ANKLE FUSION NAIL (K130051)Tornier S.A.S.2013-07-15
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL (K131382)Invivo Corporation2013-07-15
PADSCAN HD SERIES BLADDER SCANNER (K131227)Carenoso Technology Co., Ltd.2013-07-12
FACET FIXX (K131417)Nexxt Spine, LLC2013-07-12
INGENUITY DIGITAL PET/CT (K123599)Philips Healthcare (Cleveland)2013-07-12
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) (K131637)Rotation Medical, Inc.2013-07-12
MIPLATFORM MEDICAL IMAGING SUITE (K131424)Hinacom Software and Technology, Ltd.2013-07-12
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR (DEN110006)STERIS Corporation2013-07-12
IPULSE HAIR REMOVAL SYSTEM (K130315)Cyden Limited2013-07-12
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K131514)Ge Vingmed Ultrasound AS2013-07-12
SOLEA (K130420)Convergent Dental, Inc.2013-07-12
SHARPSTANK REUSABLE SHARPS CONTAINER (K131087)Rehrig Pacific Company2013-07-12
LANX FUSION SYSTEM (K131547)Lanx, Inc.2013-07-12
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K130806)Neurovision Medical Products, Inc.2013-07-12
YAMAHACHI DENTURE BASE RESINS (K131036)Yamahachi Dental Manufacturing Co.2013-07-12
CABOCHON SYSTEM (DEN110004)Cabochon Aesthetics, Inc.2013-07-12
REMEL XPECT FLU A&B (K131804)Remel, Inc.2013-07-12
SURGITRON 4.0 DUAL RF S5-IEC (K123366)Ellman International, Inc.2013-07-12
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE (K130225)Silverbay, LLC, D/B/A Quasar Bio-Tech2013-07-11
MONTERIS MEDICAL NEUROBLATE SYSTEM (K131278)Monteris Medical, Inc.2013-07-11
STIMEL-03 (K130424)Stimel, Ltd.2013-07-11
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (K123343)Microgenics Corp.2013-07-11
NEXUS ANTERIOR CERVICAL PLATE SYSTEM (K131520)Core-Nexus2013-07-11
MESOTHELIUM DENTAL MEMBRANE (K121310)Kensey Nash Corporation2013-07-11
ETCH GEL (K131248)Dmg America, LLC2013-07-11
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E (K123075)Well-Life Healthcare Limited2013-07-11
NEXUS HEMORRHOID LIGATOR (K131282)Inx Medical2013-07-11
HEARTSINE SAMARITAN PAD 350P (K123881)Heartsine Technologies, Inc.2013-07-11
NXSTAGE DOSING CALCULATOR (K130460)Nxstage Medical, Inc.2013-07-11
CLINICAL ALERT NOTIFICATION (K130339)Extension , Inc.2013-07-11
DLP CORONARY OSTIAL PERFUSION CANNULAE (K131269)Medtronic, Inc.2013-07-10
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H (K131738)Phadia AB2013-07-10
DERMA HOOD (K131338)Globalmedia Group, LLC2013-07-10
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Every clearance here is in the API, with alerts when new ones post.