Atlas FDA

2015

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

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RecordFirmDate
NeoMed NeoConnect Enteral Syringes with ENFit Connector (K143344)Neomed, Inc.2015-04-09
Kobold Ring and Tandem Applicator Set (K142330)Kobold, LLC2015-04-09
Arthrex Blunt Tip Screws with Fiber Tape (K143702)Arthrex, Inc.2015-04-09
NOVA View Automated Fluorescense Microscope (DEN140039)Inova Diagnostics, Inc.2015-04-09
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT (K150567)Medtronic, Inc.2015-04-09
Vantage Titan 3T (K143008)Toshibamedical Systems Corporation2015-04-09
PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) (K143258)4Web, Inc.2015-04-09
18ch T/R Knee Coil (K150331)Quality Electrodynamics, LLC2015-04-09
APTUS Foot System (K142581)Medartis AG2015-04-09
Equinoxe Mega Prosthesis (K143659)Exactech, Inc.2015-04-09
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (K143723)Fotona D.D.2015-04-09
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml (K150607)Osseon, LLC2015-04-09
LightStim Professional 2-Panel Light (K150098)Led Intellectual Properties, LLC2015-04-09
G-scan Brio (K142421)Esaote, S.p.A.2015-04-09
ApexM (K150183)Incontrol Medical, LLC2015-04-09
KOGENT SPETZLER LIGHTED SUCTION TUBES (K141781)Katalyst Surgical, LLC2015-04-09
O-MAR (K143253)Philips Medical Systems Nederland B.V.2015-04-09
AngioSculpt PTA Scoring Baloon Catheters (K150634)Spectranetrics2015-04-08
HIDREX PSP1000 (K133033)Hidrex GmbH2015-04-08
Polyscrew Pedicle Screw System (K150647)New Era Orthopedics, LLC2015-04-08
ELIAN Digital Diagnostic X-ray System (K150506)Osko, Inc.2015-04-08
SOMATOM Definition AS/AS+ (K143400)Siemens Medical Solutions USA, Inc.2015-04-08
CD HORIZON Spinal System, IPC POWEREASE System (K143019)Medtronic Sofamor Danek USA, Inc.2015-04-08
BLUEPRINT Patient Specific Instrumentation (K143374)Tornier S.A.S.2015-04-08
CONVENTUS PHS SYSTEM (K141737)Conventus Orthopaedics, Inc.2015-04-08
Exilite (K150051)BTL Industries, Inc.2015-04-08
NOVA Lite DAPI ANA Kit (K150155)Inova Diagnostics, Inc.2015-04-08
SOLSTICE OCT System (K150229)Life Spine, Inc.2015-04-07
CR3 Keyless Split Sample Cup Morphine - Methamphetamine (K150602)Guangzhou Wondfo Biotech Co., Ltd.2015-04-07
SOLSTICE OCT System (K143249)Life Spine, Inc.2015-04-07
UltraVision 2 Diagnostic Ultrasound System (K150580)Winprobe Corporation2015-04-07
ACCLARENT SE Inflation Device (K150172)Acclarent, Inc.2015-04-07
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! (K141913)Pjur Group Luxembourg S.A.2015-04-06
Renu Gel (K150400)Cytophil, Inc.2015-04-06
VitreaView (K150738)Vital Images, Inc.2015-04-06
ULTRASONIC SCALER (K140233)Nanning Baolai Medical Instrument Co., Ltd.2015-04-06
Vertessa Lite Y-Mesh (K150023)Caldera Medical, Inc.2015-04-06
Airlock osteosynthesis plate system (K143523)Novastep2015-04-06
Ziehm Vision RFD 3D (K142740)Ziehm Imaging GmbH2015-04-06
LUOFUCON SILVER FOAM DRESSING (K141619)Huizhou Foryou Medical Devices Co., Ltd.2015-04-06
Vertessa Lite (K150016)Caldera Medical, Inc.2015-04-06
Acumed Ankle Plating System (K143385)Acumed, LLC2015-04-06
Trevo XP ProVue Retriever (6X25mm) (K143077)Concentric Medical, Inc.2015-04-06
SOMATOM Definition Edge (K143401)Siemens Medical Solutions USA, Inc.2015-04-06
ELECTRONIC BLOOD PRESSURE MONITOR (K141683)Shenzhen Urion Technology Co., Ltd.2015-04-03
Corin TaperFit Hip Stem (K142761)Corin USA2015-04-03
2MP Color LCD Monitor, RadiForce RS240 (K150106)Eizo Corporation2015-04-03
InFill Interbody Fusion Devices (K150206)Pinnacle Spine Group, LLC2015-04-03
Santis Pedicle Screw System (K150507)Lanterna Medical Technologies2015-04-03
VAPR Tripolar Suction Electrode (K143475)Depuy Mitek2015-04-03
Aptis Medical Distal Radio Ulnar Joint Implant (K142569)Aptis Medical, LLC2015-04-03
KIMGUARD ONE-STEP Sterilization Wrap (K143053)Kimberly-Clark Health Care2015-04-03
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (K142454)Advanced Sterilization Products2015-04-03
Valleylab LS10 Generator (K143654)Covidien, LLC2015-04-03
Accu-Dent XD Tray, Accu-Dent XD Syringe (K143575)Ivoclar Vivadent, Inc.2015-04-03
Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular (K150262)Volcano Corporation2015-04-03
CYMA (K150027)Whitecap Technologies, LLC2015-04-03
LnK Cervical Interbody Fusion Cage System (K143360)L&K BIOMED Co., Ltd.2015-04-03
Arthrex Distal Radius System (K143749)Arthrex, Inc.2015-04-03
Monobond Etch & Prime (K150164)Ivoclar Vivadent, AG2015-04-03
Digital Automatic Wrist Blood Pressure Monitor MD2400 (K143733)Grandway Technology (Shenzhen) Limited2015-04-03
V8 Transluminal BAV Catheter (K150343)Intervalve, Inc.2015-04-03
EzDent-i /E2/Prora View (K150747)LK Consulting Group USA, Inc.2015-04-02
AWARE (K143372)Ambient Clinical Analytics2015-04-02
Tanning Lamp (K143043)Unilam Co., Ltd.2015-04-02
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (K150010)Cedic S.R.L.2015-04-02
Total Bilirubin (K150510)Abbott Laboratories2015-04-02
GC85A (K150165)Samsung Electronics Co., Ltd.2015-04-02
BRIGHTMATTER NAVIGATION SYSTEM (K142024)Synaptive Medical, Inc.2015-04-02
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors (K143018)Covidien2015-04-02
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator (K150413)Cymedica Orthopedics, Inc.2015-04-02
Hahn Tapered Implant System (K143353)Prismatik Dentalcraft, Inc.2015-04-02
Force Fiber OrthoTape suture (K150438)Teleflexmedical, Inc.2015-04-02
J2A Dental Implant System, J2C Dental Implant System (K150060)Kj Meditech Co., Ltd.2015-04-02
MYGAIT STIMULATION SYSTEM (K141812)Otto Bock Healthcare Products GmbH2015-04-02
IS4000 8mm Harmonic ACE Curved Shears (K143132)Intuitive Surgical, Inc.2015-04-02
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM (K141687)Aesculap, Inc.2015-04-02
Disposable Blood Pressure Cuff Guard (K150227)Pinhu Sama Medical Packing Co., Ltd.2015-04-02
Euphora Rapid Exchange Balloon Dilatation Catheter (K143480)Medtronic, Inc.2015-04-02
Reliance Interspinous Plate System (K142217)Reliance Medical Systems, LLC2015-04-02
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX (K141227)Sophysa SA2015-04-02
FLASHPAK STERILIZATION CONTAINER SYSTEM (K141826)Symmetry Medical Inc- Manchester2015-04-02
Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) (K150545)Sejoy Electronics & Instruments Co., Ltd.2015-04-02
PHYSICA KR KNEE SYSTEM (K141934)Lima Corporate S.P.A.2015-04-02
Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (K150253)Taiwan Surgical Corporation2015-04-01
Silk Road Acccess Catheter (K143459)Silk Road Medical, Inc.2015-04-01
St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter (K150631)St Jude Medical2015-04-01
SpaceOAR System (DEN140030)Augmenix, Inc.2015-04-01
K-Pack II Needle-21G x 2 (K150263)Terumo Europe N.V.2015-04-01
CRIT-LINE IV SYSTEM (K141997)Fresenius Medical Care2015-04-01
Argulated Locking Plates (K143338)Osteomed LP2015-04-01
Biomet Microfixation OmniMax MMF System (K143336)Biomet Microfixation2015-04-01
125mL CT Syringe (K142745)Coeur, Inc.2015-04-01
Sensititre Susceptibility plates (K143288)Thermo Fisher Scientific2015-04-01
ADVIA Centaur Cortisol (COR) Assy (K142723)Siemens Healthcare Diagnostics, Inc.2015-03-31
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA (K142781)Immco Diagnostics, Inc.2015-03-31
Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (K150234)Myriad Medical, LLC2015-03-31
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES (K141181)Led Technologies, LLC2015-03-31
Xcela Power Injectable PICC (K150527)Navilyst Medical, Inc.2015-03-31
Range/Denali/Mesa Spinal System (K150325)K2m, Inc.2015-03-31
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Every clearance here is in the API, with alerts when new ones post.