Atlas FDA

2017

3,200 FDA 510(k) clearances · Clearance year

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RecordFirmDate
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider (K162751)Surgical Instrument Services and Savings, Inc.2017-05-01
REDAPT Sleeved Monolithic Revision Stems (K162303)Smith & Nephew, Inc.2017-05-01
The Cranial Fusion System (K162266)Life Spine, Inc.2017-05-01
Televere Digital Imaging System (K170975)Televere Systems2017-05-01
MagVita TMS Therapy - w/MagPro R20 (K170114)Tonica Elektronik A/S2017-05-01
IontoDC (K170291)Soterix Medical, Inc.2017-05-01
NaviSuite SSI Edition (K163119)Medcom GmbH2017-05-01
Digital TENS Unit (K170145)Shenzhen Eapply Technology Co., Ltd.2017-04-29
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159)Vr Medical Technologies, LLC2017-04-28
Salvin Tenting Screw System (K161857)Salvin Dental Specialties2017-04-28
syngo.CT View&GO (K170952)Siemens Medical Solutions USA, Inc.2017-04-28
Biodesign Staple Line Reinforcement (K170945)Cook Biotech Incorporated2017-04-28
VERIFY ASSERT STEAM Process Challenge Device (K162945)STERIS Corporation2017-04-28
WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts (K162460)Wavi Co.2017-04-28
CardioCel 3D (K170951)Admedus Regen Pty, Ltd.2017-04-28
Introcan Safety 3 Closed IV Catheter (K163358)B.Braun Melsungen AG2017-04-28
ABL90 FLEX, ABL90 FLEX PLUS (K170882)Radiometer Medical Aps2017-04-28
Exactech® Truliant™ Line Extensions (K171045)Exactech, Inc.2017-04-28
BabyDance Fertility Lubricant (K162319)Fairhaven Health, LLC2017-04-28
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles (K170070)STERIS Corporation2017-04-28
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) (K161724)Radiomed Corporation2017-04-28
Z-DOSE29 (K170273)Zetta Medical Technologies, LLC2017-04-28
BrainPulse 1100 (K170926)Jan Medical, Inc.2017-04-28
Self Sealing Sterilization Pouches (K162258)Tianchang Jiarui Packaging Material Co., Ltd.2017-04-28
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) (K163667)Health Beacons, Inc.2017-04-28
Randox RX Daytona Plus Magnesium (MG) (K162200)Randox Laboratories, Ltd.2017-04-28
IOB Temperature Management System (K162679)Iob Medical, Inc.2017-04-28
van Andel Dilatation Catheter (K170616)Cook Incorporated2017-04-28
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters (K161596)AngioDynamics, Inc.2017-04-28
Scope-Assist Flushing Sink (K162120)Custom Ultrasonics, Inc.2017-04-28
Smith & Nephew SURESHOT Distal Targeting System V4.0 (K170280)Smith & Nephew, Inc.2017-04-28
Instrument kits (K160730)Anthogyr2017-04-27
Accessory Irrigation Adapter (K162142)Wilson-Cook Medical, Inc.2017-04-27
Insight Dental System (K170211)Insight Dental System2017-04-27
HAMILTON-C3 (K161450)Hamilton Medical AG2017-04-27
Star Tissue Marker (K170905)Scion Medical Technologies, LLC2017-04-27
RadiForce MX315W (K170949)Eizo Corporation2017-04-27
OneQ-SL s-Clean Implant System (K170220)Dentis Co., Ltd.2017-04-27
RSM 2430C (K170930)DRTECH Corporation2017-04-27
U.S. Laser Worx Patriot 1 family of lasers (K162334)U.S. Laser Worx2017-04-27
RAPIDEC CARBA NP (K162385)Biomerieux S.A.2017-04-27
Exactech® Alteon® HA Femoral Stem (K162732)Exactech, Inc.2017-04-26
Zenius Spinal System (K170964)Medyssey USA, Inc.2017-04-26
Apex Revision Knee System (K163332)Omnilife Science2017-04-26
NuVasive BASE Interfixated Titanium System (K170592)Nu Vasive, Incorporated2017-04-26
CalSet IGF-1 (K170938)Roche Diagnostics2017-04-26
Restrata Wound Matrix (K170300)Acera Surgical, Inc.2017-04-26
VisualEyes (K163149)Interacoustics A/S2017-04-26
HV Screw System (K170889)Wrightmedicaltechnologyinc2017-04-26
AmCAD-UV (K170069)Amcad Biomed Corporation2017-04-26
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K170942)Choicespine, LP2017-04-26
Summit Spine Yellowstone Lumbar Interbody Fusion System (K170572)Summit Spine2017-04-26
Pro-Lock CT Safety Infusion Set (K162271)Medcomp (Medical Components, Inc.)2017-04-26
Processor VP-7000, Light Source BL-7000 (K163675)Fujifilm Medical System U.S.A., Inc.2017-04-25
NeoFuse HA Enhanced PLIF/TLIF (K170511)Ht Medical, LLC2017-04-25
Triton Sponge System (K163507)Gauss Surgical, Inc.,2017-04-25
SavDenTM MTA Root Canal Filling Materials (K162661)Tyds Biotech Incorporation2017-04-25
MyoCycle Home, MyoCycle Pro (K170132)Myolyn, LLC2017-04-25
ET US SS Prosthetic system (K160670)Osstem Implant Co., Ltd.2017-04-25
Cliniview (K162799)Palodex Group OY2017-04-25
XO1 Knee Balancing System (K162237)Xpandortho, Inc.2017-04-25
Cutera enlighten III Laser System (K170936)Cutera, Inc.2017-04-25
BC-001+ Acne Purifier (K170260)Oriental Inspiration Limited2017-04-25
Oculeve Intranasal Tear Neurostimulator Device (DEN160030)Oculeve, Inc.2017-04-24
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (K163650)Wrightmedicaltechnologyinc2017-04-24
Apnea Risk Evaluation System (ARES), Model 620 (K160499)Watermark Medical2017-04-24
MindMotionPRO (K162748)Mindmaze SA2017-04-24
EVOS Small Fragment Plating System (K170887)Smith & Nephew, Inc.2017-04-24
Foot and Hand Motion (K170012)Newclip Technics2017-04-24
C-Flex Ureteral Stent Set (K162104)Cook Incorporated2017-04-24
PowerPICC Provena Catheters with SOLO Valve Technology (K162441)C.R. Bard, Inc.2017-04-24
ECG Disposable Lead Wire (K170536)APK Technology Co., Ltd.2017-04-24
Pantheon Medical Balanced Plating System (K162154)Pantheon Medical2017-04-24
VX130 Ophthalmic Diagnostic Device (K162067)Luneau Sas2017-04-24
FDR AQRO (DR-XD 1000) (K170858)Fujifilm Medical Systems U.S.A, Inc.2017-04-24
StealthConnect Remote Viewing, Planning and Collaboration System (K162655)Medtronic Navigation, Inc.2017-04-21
syngo.CT Cardiac Planning (K170221)Siemens Healthcare GmbH2017-04-21
VivaChek Ino Blood Glucose Monitoring System (K160179)Vivachek Laboratories, Inc.2017-04-21
Tomcat Cervical Spinal System (K170953)Choicespine, LP2017-04-21
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K162294)Brightway Holdings Sdn. Bhd.2017-04-21
Braun No Touch + Forehead NTF3000 Thermometer (K163516)Kaz USA, Inc., A Helen of Troy Company2017-04-21
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (K170869)Covidien2017-04-21
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories (K170865)Intuitive Surgical, Inc.2017-04-21
Aero Chrome* Select Breathable Performance Surgical Gowns (K162930)Halyard Health, Inc.2017-04-21
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil (K170721)Precision Surgical, LLC2017-04-21
Steri-Cassette and Steri-Cage Sterilization Packaging System (K162063)Sybron Dental Specialties2017-04-21
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (K163537)Covidien, LLC2017-04-21
TSIII BA Fixture (K163088)Osstem Implant Co., Ltd.2017-04-21
joimax Endovapor 2 (K170358)Joimax GmbH2017-04-21
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor (K163255)Caretaker Medical, LLC2017-04-21
DERMABOND PRINEO Skin Closure System (K163645)Ethicon, LLC2017-04-21
PercuNav Image Fusion and Interventional Navigation (K170716)Philips Ultrasound, Inc.2017-04-21
Nexxis OR, Nexxis (K170537)Barco N.V.2017-04-21
Randox RX Daytona Plus Alkaline Phosphatase (ALP) (K162275)Randox Laboratories Limited2017-04-21
Ortho System (K163677)3Shape A/S2017-04-20
K3 (K152830)Osstem Implant Co., Ltd.2017-04-20
HyperSense (K162722)Ge Medical Systems, LLC2017-04-20
Penumbra 3D Revascularization Device (K162901)Penumbra, Inc.2017-04-20
Sterile Single-use Infusion Set (K163160)Jiangxi Hongda Medical Equipment Group , Ltd.2017-04-20
HEM-9210T (K163235)Omron Healthcare, Inc.2017-04-20
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Every clearance here is in the API, with alerts when new ones post.