Atlas FDA

2012

3,135 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NATURALASE CO2 LASER SYSTEM (K110333)Focus Medical, LLC2012-04-12
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050)Starboard Medical, LLC2012-04-12
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM (K113768)Taidoc Technology Corporation2012-04-12
PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE (K120209)American I.V. Products, Inc.2012-04-12
HEMCON HEMOSTATIC GEL (K112215)Hemcon Medical Technologies Europe, Ltd.2012-04-12
TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT (K112398)Galt Medical2012-04-12
CURAD ANTIBACTERIAL BANDAGE (K113583)Medline Industries, Inc.2012-04-12
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (K113839)Parkell, Inc.2012-04-12
STERILE INSULIN PEN NEEDLE (K113186)Shina Corp.2012-04-12
TITAN MODULAR TOTAL SHOULDER SYSTEM (K112438)Ascension Orthopedic2012-04-11
NEURO CHECK DEVICE WITH IO-FLEX WIRE (K113533)Baxano, Inc.2012-04-11
KONAN SPECULAR MICROSCOPE XIV (K120264)Konan Medical, Inc.2012-04-11
BORRELIA BURGDORFERI IGG BLOT TEST (K113847)Gold Standard Diagnostics2012-04-11
ORATECT ORAL FLUID DRUG SCREEN DEVICES (K103227)Branan Medical Corporation2012-04-11
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... (K112073)Rx Devices, LLC2012-04-11
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM (K120252)Raumedic AG2012-04-11
STERILE LUBRICATING JELLY (K112110)Jianerkang Medical Dressing Company2012-04-10
PEDCAT (K113548)Curvebeam, LLC2012-04-10
AQUILION ONE (K113466)Toshiba Medical Systems Coporation, Japan2012-04-10
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT (K120774)Welch Allyn, Inc.2012-04-10
AQUILION CXL (K112989)Toshiba America Medical Systems, In.C2012-04-10
MINI MAXLOCK EXTREME PLATING SYSTEM (K120157)Orthohelix Surgical Designs, Inc.2012-04-10
FINESSE PERSONAL INSULIN DELIVERY PATCH (K111924)Calibra Medical, Inc.2012-04-10
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (K120390)Solana Surgical, LLC2012-04-10
DEFLEX (K113608)Nuxen S.R.L.2012-04-10
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (K112481)Ascension Orthopedic2012-04-09
PIXEL APP (K120473)Gauss Surgical, Inc.,2012-04-09
SONIXGPS VASCULAR ACCESS NEEDLE KIT (K120349)Ultrasonix Medical Corpation2012-04-09
WEIGHT AND BODY FAT SCALE SHINE BS0105 (K112149)Shine Overseas Marketing Limited2012-04-09
CAPSTONE CONTROL SPINAL SYSTEM (K120368)Medtronic Sofamor Danek USA, Inc.2012-04-09
AEROSYNC FOR AERODR SYSTEM (K120477)Konica Minolta Medical & Graphic, Inc.2012-04-09
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS (K112653)ACON Laboratories, Inc.2012-04-09
AQUILION PRIME (K120710)Toshibamedical Systems Corporation2012-04-06
NANOFUSE DBM (K120279)Nanotherapeutics2012-04-06
IMAGE1 GI CCU MODEL 22203020-114 (K111997)KARL STORZ Endoscopy-America, Inc.2012-04-06
RAYSTATION (K120387)Raysearch Laboratories AB2012-04-06
ETHEREA (K112505)Regulatory Insight, Inc.2012-04-06
MULTI-MODALITY IMAGE FUSION (K120187)Igt, LLC Dba Eigen2012-04-06
EOS (K120721)Eos Imaging2012-04-06
THE DOME GX4MP COLOR NONITOR (K120709)Nds Surgical Imaging2012-04-06
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL (K120448)Apex BioTechnology Corp.2012-04-06
ARTHREX BIO-SUTURE (K112899)Arthrex, Inc.2012-04-06
POWER WHEELCHAIR (K113463)Suzhou KD Medical Appliance Co., Ltd.2012-04-06
SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND (K120095)Depuy Mitek, A Johnson & Johnson Company2012-04-06
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K120388)Hologic, Inc.2012-04-06
CERVICAL PLATE (K113170)Eisertech, LLC2012-04-06
OEC 9900 ELITE (K120613)Ge Healthcare Surgery GE Oec Medical Systems, Inc.2012-04-06
SYNAPSE 3D BASE TOOLS (K120361)Fujifilm Medical Systems U.S.A, Inc.2012-04-06
STELLAR 150 (K113640)Resmed Germany, Inc.2012-04-05
ADVANTAGE LASER SYSTEM (K113502)Lutronic Corporation2012-04-05
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM (K120570)Choicespine, LP2012-04-05
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES (K120828)Coloplast A/S2012-04-05
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K113626)Sorin Group Italia S.R.L.2012-04-05
STEAM DOT BLU PROCESS INDICATOR (K111453)Propper Mfg. Co., Inc.2012-04-05
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT (K113674)Handpiece Headquarters, Inc. - Hpr, Inc.2012-04-05
GRINDCARE MEASURE (K113677)Medotech A/S2012-04-05
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE (K110481)Asi Medical, Inc.2012-04-05
CMI IMPLANT IS SYSTEM (K113554)Neobiotech Co., Ltd.2012-04-05
EAGLE EYE PLATINUM ST CATHETER (K120697)Volcano Corporation2012-04-05
2GC HIP/KNEE MODULAR SPACER (K112470)Mandell Horwitz Consultants, LLC2012-04-05
NUCAL (K120003)Pulpdent Corporation2012-04-05
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT (K120667)Smith & Nephew, Inc.2012-04-04
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433)Focus Diagnostics, Inc.2012-04-04
EVEREST SPINAL SYSTEM (K120656)K2m, Inc.2012-04-04
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674)Covidien2012-04-04
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM (K120686)Codman & Shurtleff, Inc.2012-04-04
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM (K111480)Technology Delivery Systems, Inc.2012-04-04
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038 (K111274)Jetprep, Ltd.2012-04-04
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM (K111636)Gunnell, Inc.2012-04-03
PAGEWRITER TC 20, 30, 50, 70 (K113144)Philips Medical Systems2012-04-03
ENCORE 26 ADVANTAGE KIT (K120694)Boston Scientific Corp2012-04-03
EPICARE YAG (K113115)Light Age, Inc.2012-04-03
REPROCESSED FEMORAL COMPRESSION DEVICE (K120204)Sterilmed, Inc.2012-04-03
RTVUE XR OCT (K120238)Optovue, Inc.2012-04-03
HAMILTON-T1 (K120670)Hamilton Medical AG2012-04-03
SECURIS SPINAL FIXATION (K113361)Cumtom Spine2012-04-03
AVAIRA (ENFILCON A) CONTACT LENS (K113759)CooperVision, Inc.2012-04-03
STAPHYLOCOCCUS QUICKFISH BC (K113371)Advandx, Inc.2012-04-03
PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES (K120065)Plaxtron Industrial (M) Sdn. Bhd.2012-04-03
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR (K120190)Rich Mountain Medical Products, Inc.2012-04-02
CLEAR + BRILLIANT LASER SYSTEM (K120433)Solta Medical, Inc.2012-04-02
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) (K112982)Small Bone Innovations, Inc.2012-04-02
A BAER WITH ABAER I/O FUNCTION (K112247)Natus Medical Incorporated2012-04-02
PATHASSIT LIGHT SEEKER (K120735)Entellus Medical, Inc.2012-04-02
ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE (K113829)Materialise NV2012-04-02
HYBRID GRAFT (K111695)Cook Biotech, Inc.2012-04-02
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES (K112426)Xian Friendship Medical Electronics Co., Ltd.2012-04-02
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS (K120802)Wrightmedicaltechnologyinc2012-04-02
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 (K120330)Penumbra, Inc.2012-04-02
TIGER SPINE SYSTEM (K120696)Corelink, LLC2012-04-02
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S (K120379)Kuraray Medical, Inc.2012-03-30
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA (K113431)Bettini S.P.A.2012-03-30
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH (K112119)William Cook Europe Aps2012-03-30
ULTRA BEAUTY (K112351)Johari Digital Healthcare , Ltd.2012-03-30
SIMPLE T NASAL MASK (K120145)Respironics, Inc.2012-03-30
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (K103834)Bio-Rad Laboratories2012-03-30
URETRON MODEL URT (K111058)Med-Sonics Corp.2012-03-30
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS (K112452)AngioDynamics, Inc.2012-03-30
DIAZYME CYSTATIN C POC TEST KIT (K111664)Diazyme Laboratories2012-03-30
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Every clearance here is in the API, with alerts when new ones post.