FDA 510(k) clearances — page 218
clearances on record, most recent first.
Clearances — page 218
21,701–21,800 of 175,699- K191726 — mont blanc & mont blanc MIS Spinal Systems
- K192012 — Capillus 112, Capillus 244
- K192199 — CRC PC Smart Chamber K1
- K192293 — uDR 592h, uDR 596i
- K183370 — PeraMobile and PeraWatch
- K183521 — CNAP Monitor
- K190815 — BrainScope TBI
- K191301 — Ceribell Pocket EEG Device
- K191355 — 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
- K191605 — Neocis Guidance System (NGS)
- K191619 — TurboTemp EZ
- K191811 — Catalyst OrthoScience CSR Shoulder System
- K181602 — Pioneer Elite Diode Laser
- K181614 — Sterling Supreme Diode Laser
- K183268 — AI-Rad Companion (Cardiovascular)
- K190484 — BH Medical Dental Barrier Sleeves and Barrier Film
- K190683 — External Counterpulsation System
- K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
- K191945 — KOWA nonmyd 8
- K181601 — Precise SHP Diode Laser
- K183444 — Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
- K190668 — Encompass 15 Channel Head Coil, 3T
- K191354 — Ti3Z Cervical Interbody System
- K191421 — Sofacia System
- K192172 — Connected OR Hub with Device and Voice Control
- K183215 — Focus TENS Therapy, Model PM710-M/-L
- K181986 — Klinly Ultrasonic Tongue Cleaner
- K182355 — Secret RF Smartcure Applicator with electrodes
- K182751 — Reusable Temperature Probe
- K182886 — Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
- K183027 — Steerable catheter control system
- K183416 — Rhino-Laryngo Videoscope Olympus ENF-VT3
- K183516 — PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K183525 — EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
- K183574 — SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
- K183665 — Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
- K190213 — Yikang Endotracheal Tube
- K190250 — Microscope Navigation
- 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 Drugs
- K190499 — Gem FlowCoupler System
- K191102 — Precision S 4K Sinuscope
- 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 Lens
- K191294 — Transvaginal Access Platform
- K191366 — Vacutore Air/Water Bottle Tubing
- K191392 — AcQMap High Resolution Imaging and Mapping System
- K191435 — IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
- K191528 — Venus Legacy Pro Device
- K191531 — Sure-Fine Insulin Syringes
- K191577 — Willow Wearable Breast Pump 2.0
- K191782 — TTC Phantom Intramedullary Nail System
- K191845 — Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
- K192160 — EVO Platform
- K192188 — Aquilion ONE (TSX-306A/3) V10.0
- K192226 — Lumify Diagnostic Ultrasound System
- K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190
- K183433 — FUJIFILM Ultrasonic Endoscope
- K183563 — Holinwon 30
- K190383 — GM501 Wash
- K190899 — bili-hut
- K190930 — SmarTemp X1
- K191004 — Advocate Non-Contact Infrared Thermometer
- K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
- K191625 — Persona Revision Knee System
- K191710 — FlowTriever Retrieval/Aspiration System
- K191853 — Dual-Safety Pen Needle
- K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
- K192119 — 3M Clarity Aligners
- K192123 — HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
- K192148 — Freedom Primary PCK
- K183347 — K3
- K190758 — Opus Bulk Fill APS, Opus Bulk Fill Flow APS
- K190844 — Akesis Galaxy
- K191034 — VPS Impression Material
- K191070 — Signia Small Diameter Reloads
- K191179 — Myo Plus
- K191503 — MobileRay Pulse SE Digital Imaging System
- K191908 — MTS Imipenem 0.016-256 µg/mL
- K192088 — GOLNIT Non-aborbable PTFE Surgical Suture
- K192116 — Human IgA liquid reagent kit for Use on SPAPlus
- K192155 — Smith & Nephew DYONICS 25 Fluid Management System
- K192156 — Cartiva SCI instrumentation set
- K182765 — 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
- K183438 — Geomed Vascular Dilators
- K191500 — NuVasive® ACP System
- K191617 — Syntec Tibial Nail System
- K192106 — AcQRef Introducer Sheath
- K183407 — Triton Cage
- K183475 — T1-CS, T1-C
- K190449 — Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
- K190702 — Lumipulse G whole PTH
- K190719 — Artemis Eye System
- K190810 — OPERA, OPERA eco
- K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin
- K191415 — Pathfinder Endoscope Overtube
- K191471 — Carnation Ambulatory Monitor
- K191547 — ReliefBand
- K191554 — LightWalker Laser System Family
- K191664 — SelectFlex 072 Neurovascular Access System
- K191732 — Sutter RaVoR Bipolar Electrodes
- K191786 — Cyclops Anterior Cervical Plate System
Data sourced from openFDA. This site is unofficial and independent of the FDA.