510(k) Clearances in 2019 — Page 20

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 20 of 59)
510(k) clearancesDetails
K182257 — UPnRIDEUpnride Robotics , Ltd. Sep 12, 2019
K192293 — uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. Sep 12, 2019
K191301 — Ceribell Pocket EEG DeviceCeribell, Inc. Sep 11, 2019
K183521 — CNAP MonitorCnsystems Medizintechnik GmbH Sep 11, 2019
K191355 — 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask3M Healthcare Sep 11, 2019
K190815 — BrainScope TBIBrainscope Company, Inc. Sep 11, 2019
K183370 — PeraMobile and PeraWatchPerahealth, Inc. Sep 11, 2019
K191811 — Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc. Sep 11, 2019
K191605 — Neocis Guidance System (NGS)Neocis, Inc. Sep 11, 2019
K191619 — TurboTemp EZZest Anchors, LLC Sep 11, 2019
K181614 — Sterling Supreme Diode LaserCAO Group, Inc. Sep 10, 2019
K191945 — KOWA nonmyd 8Kowa Company , Ltd. Sep 10, 2019
K181602 — Pioneer Elite Diode LaserCAO Group, Inc. Sep 10, 2019
K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. Sep 10, 2019
K183268 — AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. Sep 10, 2019
K190683 — External Counterpulsation SystemVamed Medical Instrument Co., Ltd. Sep 10, 2019
K190484 — BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd. Sep 10, 2019
K181601 — Precise SHP Diode LaserCAO Group, Inc. Sep 9, 2019
K191421 — Sofacia SystemSofwave Medical, Ltd. Sep 9, 2019
K183444 — Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level DisinfectorCenorin, LLC Sep 9, 2019
K191354 — Ti3Z Cervical Interbody SystemZavation Medical Products, LLC Sep 9, 2019
K190668 — Encompass 15 Channel Head Coil, 3TQfix Sep 9, 2019
K192172 — Connected OR Hub with Device and Voice ControlStryker Sep 9, 2019
K183215 — Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. Sep 7, 2019
K190499 — Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc. Sep 6, 2019
K183574 — SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare , Ltd. Sep 6, 2019
K191531 — Sure-Fine Insulin SyringesShina Med Corporation Sep 6, 2019
K190213 — Yikang Endotracheal TubeJiangxi Yikang Medical Instrument Group Co., Ltd. Sep 6, 2019
K191782 — TTC Phantom Intramedullary Nail SystemParagon 28, Inc. Sep 6, 2019
K191121 — Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact LensLentechs, LLC Sep 6, 2019
K191294 — Transvaginal Access PlatformApplied Medical Resources Corp. Sep 6, 2019
K190250 — Microscope NavigationBrainlab AG Sep 6, 2019
K183525 — EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp. Sep 6, 2019
K183665 — Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseJiangsu Micsafe Medical Technology Co., Ltd. Sep 6, 2019
K181986 — Klinly Ultrasonic Tongue CleanerKea Products, Ltd. Sep 6, 2019
K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4Nalu Medical, Inc. Sep 6, 2019
K191102 — Precision S 4K SinuscopeStryker Sep 6, 2019
K191845 — Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)Barco N.V. Sep 6, 2019
K183516 — PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax Of America, Inc. Sep 6, 2019
K192160 — EVO PlatformQuanta System Spa Sep 6, 2019
K191392 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Sep 6, 2019
K192226 — Lumify Diagnostic Ultrasound SystemPhilips Health Care Sep 6, 2019
K192188 — Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation Sep 6, 2019
K182751 — Reusable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. Sep 6, 2019
K191366 — Vacutore Air/Water Bottle TubingSmartdata Suzhou Co., Ltd. Sep 6, 2019
K191528 — Venus Legacy Pro DeviceVenus Concept USA, Inc. Sep 6, 2019
K183027 — Steerable catheter control systemStereotaxis, Inc. Sep 6, 2019
K183416 — Rhino-Laryngo Videoscope Olympus ENF-VT3Olympus Medical Systems Corp. Sep 6, 2019
K182355 — Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd. Sep 6, 2019
K190403 — Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy DrugsEver Global (Vietnam) Enterprise Corporation Sep 6, 2019
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