FDA 510(k) clearances — page 226
clearances on record, most recent first.
Clearances — page 226
22,501–22,600 of 176,542- K190708 — AccelFix Lumbar Interbody Fusion Cage System
- K191576 — Mercury® Spinal System, Overwatch® Spinal System
- K191641 — AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws
- K191676 — Intra.Ox 2.0 Handheld Tissue Oximeter
- K191685 — PicoWay Laser System
- K191688 — SubtleMR
- K191800 — Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
- K191378 — 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- K181478 — Roosin Xeroform Petrolatum Dressing
- K182921 — Infinix Universal Composite
- K183364 — Bellavista
- K183586 — CapMedic
- K183670 — Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens +1 more
- K190005 — Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
- K190288 — Arthrex Tenodesis Button
- K190473 — ACIST RXi System and Navvus II Catheter
- K190830 — TDM Screw Systems
- K190841 — SCENARIA View
- K190869 — Pulse Oximeter
- K190932 — RFID Localization System
- K191021 — Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
- K191273 — Multi-Link X2 ECG and SpO2 Adapter
- K191459 — JuggerStitch Meniscal Repair Device
- K191595 — ARCHITECT STAT High Sensitivity Troponin-I
- K191599 — NICO Myriad NOVUS
- K191801 — PROBEAT-CR
- K191949 — UNFOLDER Vitan Inserter
- K192217 — NCB Plating System Distal Femur and Proximal Tibia
- K192304 — SIS Software Version 3.6.0
- K182257 — UPnRIDE
- K183662 — Saline Wound Wash, SteriCleanse(TM)
- K183695 — OrthoAnalysis Software
- K190002 — Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
- K190398 — Republic Spine Restore Intervertebral Body Fusion System
- K190768 — ARTIS icono
- K190780 — syngo Application Software
- K191148 — Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set
- K191300 — MectaLock Ti Suture Anchor
- K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
- K191516 — Ali Interbody Fusion System
- K191518 — CO2 Laser System
- K191587 — L360 Thigh System
- K191629 — faceLITE
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.