Atlas FDA

2013

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

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RecordFirmDate
QUANTUM DENTAL IMPLANT SYSTEM (K130787)Quantum Bioengineering, Ltd.2013-06-13
SHASER V-MINI HAIR REMOVAL SYSTEM (K130015)Shaser, Inc.2013-06-13
ORTHOSENSOR KNEE BALANCER (K130380)Orthosensor, Inc.2013-06-13
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE (K130753)Watchdog Group, LC2013-06-13
PIPELINE TOTAL HIP SYSTEM (K131237)Pipeline Orthopedics2013-06-13
ENTERAL NUTRITION WARMER (K122449)Acacia, Inc.2013-06-13
PLATEAU SPACER SYSTEM TITANIUM (K130630)Life Spine, Inc.2013-06-13
GUIDEWIRE, PURSUER SERIES (K130104)Oscor, Inc.2013-06-13
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE (K122973)Medgyn Products, Inc.2013-06-12
NEXUS TKO-6P LUER ACTIVATED DEVICE (K130416)Nexus Medical, LLC2013-06-12
EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (K123261)Euroimmun US2013-06-12
MINT (K130191)Hans Biomed Corporation2013-06-12
VUSION CS PLUS (K122588)Ortho Development Corp.2013-06-12
SMR 3-PEGS GLENOIDS (K130642)Lima Corporate S.P.A.2013-06-12
Z-800 INFUSION SYSTEM (K130690)Zyno Medical, LLC2013-06-12
DISPOSABLE CIRCULAR STAPLER (K131303)Changzhou City Zhiye Medical Devices Institute Co.2013-06-11
T3 (K123292)Medcomp2013-06-11
PREVENT SEAL (K122521)Itena Clinical2013-06-11
MAMMOMAT INSPIRATION PRIME (K123520)Siemens Medical Solutions USA, Inc.2013-06-11
ENGLER 25K SERIES ULTRASONIC INSERTS (K122748)Engler Engineering Corp.2013-06-11
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER (K131528)CIVCO Medical Instruments Co., Inc.2013-06-11
SONENDO ENDOTHERAPY SYSTEM (K130025)Sonendo, Inc.2013-06-11
DR LONG LENGTH IMAGING SOFTWARE (K130567)Carestream Health, Inc.2013-06-11
PATHASSIST LED LIGHT FIBER (K130503)Entellus Medical, Inc.2013-06-11
STARBAND (K124023)Orthomerica Products, Inc.2013-06-10
DISPOSABLE 330PSI EXTENSION LINES (K120892)Coeur, Inc.2013-06-10
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K130907)Stryker Trauma AG2013-06-10
ACUMED TOTALW RIST FUSION PLATING SYSTEM (K131380)Acumed, LLC2013-06-10
IMR SOFTWARE APPLICATION (K123576)Philips Healthcare (Cleveland)2013-06-07
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945)Hitachi Chemical Diagnostics, Inc.2013-06-07
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785)Diazyme Laboratories2013-06-07
LIMACORPORATE SMR CTA HUMERAL HEADS (K131112)Lima Corporate S.P.A.2013-06-07
FASTBRACES CERAMIC BRACKETS (K130446)Orthodontic Design and Production, Inc.2013-06-07
4WEB OSTEOTOMY BONE WEDGE (K130185)4-Web, Inc.2013-06-07
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051)Hitachi Chemical Diagnostics, Inc.2013-06-07
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD (K130636)Vidar Systems Corp.2013-06-07
XGEO GU60 (K123105)Samsung Electronics Co., Ltd.2013-06-07
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR (K130464)Carestream Health, Inc.2013-06-07
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (K131217)Hitachi Chemical Diagnostics, Inc.2013-06-07
ISR'OBOT MONA LISA (K130944)Biobot Surgical Pte., Ltd.2013-06-07
BEARING NSPVA EMBOLIZATION PARTICLES (K130259)Merit Medical Systems, Inc.2013-06-07
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K131300)Access Scientific, LLC2013-06-07
ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE (K131115)Nds Surgical Imaging2013-06-07
PRELUDE SHEATH INTRODUCER (K130791)Merit Medical Systems, Inc.2013-06-07
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK (K130726)Intuitive Surgical, Inc.2013-06-07
NATRATONE (K121902)Orelle Corporation, Ltd.2013-06-06
VECTOR PTA BALLOON DILATATION CATHETER (K131329)R4 Vascular, Inc.2013-06-06
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (K123394)Coreleader Biotech Co., Ltd.2013-06-06
CRITICAL CARE VENTILATOR (K120931)Oricare, Inc.2013-06-06
WIZARD 230 NASAL PILOW MASK (K121642)Apex Medical Corp.2013-06-06
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K131346)Microlife Intellectual Property GmbH2013-06-06
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS (K130739)Siemens Medical Solutions USA, Inc.2013-06-06
DAS MEDICAL EQUIPMENT DRAPES (K121436)Das Medical, LLC2013-06-06
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE (K130149)United Orthopedic Corporation2013-06-06
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE (K123481)Convatec, Inc.2013-06-06
AQUILION PRIME, V5.00 (K130645)Toshibamedical Systems Corporation2013-06-06
XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR (K131103)Sorin Group Italia S.R.L.2013-06-06
PHOTON PHOTON PLUS (K122020)Zolar Technology & Mfg Co., Inc.2013-06-05
HEARTSTRING III PROXIMAL SEAL SYSTEM (K130382)Boston Scientific Corporation2013-06-05
F&P SIMPLUS FULL FACE MASK (K130328)Fisher & Paykel Healthcare Limited2013-06-05
NOBELPROCERA PEEK ABUTMENTS (K120954)Nobel Biocare AB2013-06-05
ABBOTT CARBAMAZEPINE ASSAY (K123518)Microgenics Corporation2013-06-05
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT (K123423)Meridian Bioscience, Inc.2013-06-05
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER (K130598)Inspirx, Inc.2013-06-05
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM (K130427)Pioneer Surgical Technology, Inc.2013-06-05
CD HORIZON SPINAL SYSTEM (K131321)Medtronic Sofamor Danek USA2013-06-05
TEMPUS PRO PATIENT MONITOR (K130773)Remote Diagnostic Technologies , Ltd.2013-06-05
TRC-50DX RETINAL CAMERA (K123101)Topcon Medical Systems, Inc.2013-06-05
NEUROEPG SYSTEM (K123843)Strohl Medical Technologies2013-06-05
WART FREEZE (K130599)Koninklijke Utermohlen NV2013-06-05
VIDAS LYME IGM (K122979)Biomerieux S.A.2013-06-04
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE (K130290)Intel-Ge Care Innovations, LLC2013-06-04
ULTRACHECK CURVE BLOOD PRESSURE CUFFS (K122365)Statcorp Medical2013-06-04
INFILL OBLIQUE TLIF DEVICE (K124012)Pinnacle Spine Group, LLC2013-06-04
LYOPLANT ONLAY (K122791)Aesculap, Inc.2013-06-04
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (K130640)Medtronic Sofamor Danek USA, Inc.2013-06-04
VALVED TEARAWAY INTRODUCER GENERATION II (K124046)Medical Components, Inc.2013-06-03
FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (K130507)Footprint Medical, Inc.2013-06-03
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR (K123885)Osteomed LP2013-06-03
HUMAN CAERULOPLASMIN KIT (K122965)The Binding Site Group , Ltd.2013-06-03
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) (K123653)Bisco, Inc.2013-06-03
TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 (K122473)Hill-Rom2013-06-03
MAXTORQUE SCREW SYSTEM (K131324)Orthohelix Surgical Designs, Inc.2013-05-31
ENDOFORM RECONSTRUCTIVE TEMPLATE (K130547)Mesynthe, Ltd.2013-05-31
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM (K130129)Arthrex, Inc.2013-05-31
VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332)Ortho-Clinical Diagnostics, Inc.2013-05-31
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES (K122700)Prosben, Inc.2013-05-31
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K130267)Spineart2013-05-31
OSTEOMED EXTREMIFUSE SYSTEM (K130412)Osteomed2013-05-31
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (K130338)ImpediMed Limited2013-05-31
SURGISEAL TOPICAL SKIN ADHESIVE (K130474)Adhezion Biomedical, LLC2013-05-31
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (K120900)Cliniqa Corporation2013-05-31
MEDLINE CANNULATED SCREW (K130319)Medline Industries, Inc.2013-05-31
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY (K130498)Bacterin International, Inc.2013-05-31
PHT-6500, PHT-60CFO (K130432)VATECH Co., Ltd.2013-05-31
GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (K131136)Bionostics, Inc.2013-05-31
SINGLE ENERGY (SE) FEMUR EXAMS (K130277)Hologic, Inc.2013-05-31
STRIDE UNICONDYLAR KNEE (K123380)Blue Belt Technologies, Inc.2013-05-31
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K130293)Cook, Inc.2013-05-31
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (K131232)Guangzhou Wondfo Biotech Co., Ltd.2013-05-31
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Every clearance here is in the API, with alerts when new ones post.