Atlas FDA

2015

3,020 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PURICORE WOUND HYDROGEL SPRAY DRESSING (K141863)Puricore, Inc.2015-05-14
SCIg60 Infuser, Infuset (K142319)Emed Technologies Corporation2015-05-14
DISPOSABLE CERVICAL BRUSH (K141057)Ningbo Hls Medical Products Co., Ltd.2015-05-14
Tinnitus Sound Generator Module (K150171)Gn Resound A/S2015-05-14
Planmed Verity (K143435)Planmed OY2015-05-14
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 (K140150)Hmd Biomedical, Inc.2015-05-14
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere (K150458)Exactech, Inc.2015-05-14
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (K142629)Fujifilm Medical System U.S.A., Inc.2015-05-14
Bookwalter Gordon Adjustable Compression Element (K143078)Symmetry Surgical2015-05-14
MDK HANDPIECES (K141886)Modern Korea Co., Ltd.2015-05-13
SpineFrontier Lumbar Interbody Fusion Device System (K142504)Spinefrontier, Inc.2015-05-13
JMS Harmony A.V. Fistula Needle Set (K151017)JMS North America Corporation2015-05-13
IntelliVue Patient Monitor (K150310)Philips Medizin Systeme Boeblingen GmbH2015-05-13
Hematocrit and Metabolite QUALICHECK (K150226)Radiometer Medical Aps2015-05-13
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (K150356)Healgen Scientific,, LLC2015-05-13
BLUE VINYL GLOVES POWDER FREE (K150224)Zibo Sanying Trade Co., Ltd.2015-05-12
Venus Viva SR Device (K150161)Venus Concept , Ltd.2015-05-12
GEMORE OTC TENS (K150681)Gemore Technology Co, Ltd.2015-05-12
OASYS System (K150539)Stryker Corporation2015-05-12
Mont Blanc Spinal System (K150185)Spineway2015-05-12
syngo.CT Lung CAD (K143196)Siemens AG Medical Solutions2015-05-12
Miromatrix Biological Mesh RS (K150341)Miromatrix Medical, Inc.2015-05-12
Coda LP Balloon Catheter (K150970)Cook Incorporated2015-05-12
Dorsal Spanning Plate (K150675)Skeletal Dynamics, LLC2015-05-12
The Octane Straight Intervertebral Fusion Device, Ti Coated (K150152)Exactech, Inc.2015-05-11
Elite Nitinol Fixation System (K150125)Biomedical Enterprises, Inc.2015-05-11
Life Spine Cannulated Screws (K150126)Life Spine, Inc.2015-05-11
Renovis Surgical Hip Replacement System (K143647)Renovis Surgical Technologies, Inc.2015-05-11
GYMFORM ABS & CORE (K142055)Well Brain International , Ltd.2015-05-11
NobelActive (K142260)Nobel Biocare AB2015-05-11
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control (K142543)ACON Laboratories, Inc.2015-05-11
Magic3 Go Intermittent Urinary Catheter (K150345)C.R. Bard, Inc.2015-05-11
Terason uSmart3200T Ultrasound System (K150533)Teratech Corp.2015-05-09
Snap-Off Self-Compressive Screw (K150772)Neosteo2015-05-08
ORTHOPHOS SL (K150217)Sirona Dental Systems GmbH2015-05-08
Aspen Laser Systems Therapy Laser System (K150138)Aspen Laser Systems, LLC2015-05-08
Jumong Series (K150816)Sg Healthcare Co, Ltd.2015-05-08
MultiBand SENSE (K143606)Philips Medical Systems Nethrlands BV2015-05-08
Subtalar Spacer System (STS) (K150213)Wrightmedicaltechnologyinc2015-05-08
VitalBeam (K150706)Varian Medical Systems, Inc.2015-05-08
MedSource Sharps Dart (K150333)Medsource International, LLC2015-05-08
Rapid Therapy System (K143531)Magstim Company Limited2015-05-08
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm (K150946)Ostial Corporation2015-05-08
Touch Ultrasound (K150342)Carestream Health, Inc.2015-05-08
Level Sensor, Level Sensor Tape (K150530)Medtronic, Inc.2015-05-08
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (K143462)Benq Materials Corporation2015-05-08
740 SELECT (K150620)Cas Medical Systems, Inc.2015-05-08
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) (K151007)Jvckenwood Corporation2015-05-08
VariSeed 9.0 (K150636)Varian Medical Systems, Inc.2015-05-08
DERMAFINE (K140905)Invado Pharmaceuticals2015-05-08
CUFF PILOT, SURE SEAL (K142103)Teleflexmedical, Inc.2015-05-08
Stryker Footed Attachments and Cutting Accessories (K143399)Stryker Corp.2015-05-08
Chesapeake Stabilization System (K142487)K2m, Inc.2015-05-07
entré Model PD08-U (K143185)Tactile Systems Technology, Inc.2015-05-07
Mecta-C TiPEEK (K142744)Medacta International2015-05-07
QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators (K150267)Maquet Cardiopulmonary, AG2015-05-07
MRI PATIENT MONITORING SYSTEM TESLA M3 (K142032)Mipm Mammendorfer Institut Fur Physik Und Medizin2015-05-07
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System (K143750)Apex BioTechnology Corp.2015-05-07
Diagnostic X-ray System (K150663)Osko, Inc.2015-05-07
Tensyn Plug (K150359)Dallen Medical, Inc.2015-05-07
Gemini Bonded Sterilization Wrap (K143147)Medline Industries, Inc.2015-05-07
The Vest Airway Clearance System (K142482)Hill-Rom Services Private Limited2015-05-07
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case (K142717)Ni Hau Industrial Co., Ltd.2015-05-07
GC KommonBase (K143667)Gc Orthodontics America, Inc.2015-05-07
Elite L Expandable Lumbar Fusion System (K150954)Innova Spinal Technologies, LLC2015-05-07
Insightra Freedom Ventral Hernia Repair System (K142192)Insightra Medical2015-05-07
FORA GD43 Blood Glucose Monitoring System (K143467)Taidoc Technology Corporation2015-05-07
JAZZ System (K143759)Implanet, S.A.2015-05-07
Blue Mountain Cervical Plate System (K150036)Spineway2015-05-07
StatStrip Glucose Hospital Meter (K150281)Nova Biomedical Corporation2015-05-06
Spiral Flow Peripheral Vascular Graft (K150389)Vascular Flow Technologies, Ltd.2015-05-06
Acclarix Diagnostic Ultrasound System (K150999)Edan Instruments, Inc.2015-05-06
Luxisse+ (K150056)Heany Industries, Inc.2015-05-06
Electric Breast Pump (K143585)Shantou Xinghe Electrical Apparatuses Co., Ltd.2015-05-06
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series (K143434)Abbott Medical Optics, Inc.2015-05-06
Terumo Circuit Tubing (K150536)Terumo Cardiovascular Systems Corporation2015-05-05
Pasture 60S Surgical Mask (K141875)Pasture Pharma Pte, Ltd.2015-05-05
Stryker MEDPOR TITAN 3D Orbital Floor Implant (K142568)Stryker2015-05-05
ILUMIEN, Drageonfly OPTIS Imaging Catheter (K150237)Lightlab Imaging, Inc.2015-05-05
NovaCross Microcatheter (K143608)Nitiloop , Ltd.2015-05-04
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
EUROIMMUN LYME ELISA(IgG/IgM) (K142038)Euroimmun US2015-05-04
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE (K141910)Biologic Therapies, Inc.2015-05-04
Maxima PRO 45L (K141576)Kavo DO Brasil Industria E Comercio Ltda2015-05-04
Modified Bencox Hip System (K150007)Corentec Co., Ltd.2015-05-04
ERBECRYO 2 Cryosurgical Unit with accessories (K151041)Erbe USA, Inc.2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 (K143734)Grandway Technology (Shenzhen) Limited2015-05-02
Pyrenees Cervical Plate System (K142212)K2m, Inc.2015-05-01
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System (K143528)Zimmer Dental, Inc.2015-05-01
ADVIA Centaur TSH3-Ultra (K150403)Siemens Healthcare Diagnostics, Inc.2015-05-01
Elecsys Progesterone III Cal Check 5 (K150955)Roche Diagnostics2015-05-01
Bifix Temp (K143212)Voco GmbH2015-05-01
Sonendo GentleWave System (K143448)Sonendo, Inc.2015-05-01
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System (K150818)Zimmer, Inc.2015-05-01
Rush Medullary Pins (K150626)Zimmer, Inc.2015-05-01
BGM009 BLOOD GLUCOSE MONITORING SYSTEM (K141036)Apex BioTechnology Corp.2015-05-01
2D Mercy TAPE & 3D Mercy TAPE (K142469)Children'S Mercy Hospital2015-05-01
V10 system (K150035)Viora , Ltd.2015-05-01
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Every clearance here is in the API, with alerts when new ones post.