FDA 510(k) clearances — page 169
clearances on record, most recent first.
Clearances — page 169
16,801–16,900 of 176,479- K211513 — sam X1 Long Duration Ultrasound Device
- K211631 — Surgical Face Mask
- K211813 — Triton
- K211957 — QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
- K212097 — Disposable medical surgical mask
- K212322 — Cellvizio I.V.E. system with Confocal Miniprobes
- K201573 — Brain Perfusion (BP) application
- K203089 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K203820 — ASPIVIX v1.1 Cervical Suction Tenaculum
- K210201 — Deep Transcranial Magnetic Stimulation (DTMS) System
- K210998 — ROSA Hip System
- K211376 — STARband
- K211671 — Journey II Mid-Level Tibial Inserts
- K211708 — Disposable Medical Nitrile Gloves
- K201094 — iMap 3D Mapping & Navigation System (iMap System)
- K202636 — Metallic Fabric Electrodes
- K203236 — Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
- K210569 — Disposable Monopolar Laparoscopic Shafts and Reusable Handles
- K210695 — CPM Medical Consultants Tibial Revision Knee System
- K210841 — NuVent Eustachian Tube Dilation Balloon
- K211294 — Multi-Link X2 ECG Cable and Leadwire System
- K211654 — Penumbra System (Reperfusion Catheter RED 72)
- K211703 — Insignia Hip Stem
- K212066 — Adena-Zina System
- K212230 — TruSPECT Radiological Image Processing Station
- K210381 — I.V. Administration Set
- K192823 — MEGA-TMS
- K200913 — Clearblue® Early Digital Pregnancy Test
- K202279 — Insignis Subcutaneous Needle Sets
- K203693 — Nisus Touch Negative Pressure Wound Therapy Pump
- K203817 — Tyber Medical Anatomical Plating System
- K210336 — Neodent Implant System - Zirconia Implant System
- K210671 — Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
- K210858 — VITROS Chemistry Products PHBR Slides
- K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K211383 — NFLK-2501 Portable X-ray Unit
- K211519 — Every Cycle Reusable Tampon Applicator
- K211563 — Pitch-Patchs
- K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
- K211588 — Caretaker Platform, VitalStream Platform, CT5
- K211777 — ARCO FP-S
- K211860 — Powder Free Nitrile Patient Examination Gloves, Blue Color
- K211969 — EMM Ultrasonic Transducer Cover
- K212206 — Jot Dx Insertable Cardiac Monitor
- K212228 — WATCHMAN FXD Curve Access System
- K212229 — White Endoseal MTA
- K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
- K203363 — Crosser iQ CTO Recanalization System
- K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
- K210510 — Disposable Surgical Gown
- K210661 — SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
- K210912 — Excelsius3D
- K210946 — Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
- K211179 — InferRead CT Stroke.AI
- K211205 — Prase-C Anterior Cervical Plate System
- K211863 — eVolve PACS
- K212007 — VERTICALE Navigation Instruments
- K202536 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
- K203152 — Disposable Face Mask
- K203448 — uCT ATLAS with uWS-CT-Dual Energy Analysis
- K203643 — Sensatronic Reusable Temperature Probes
- K210687 — CONTOUR® NEXT ONE Blood Glucose Monitoring System
- K210759 — Solo, Swing Maxi
- K211102 — FreeStyle Libre 2 Flash Glucose Monitoring System
- K211353 — Medical Face Mask
- K211552 — Surgical mask
- K211883 — QUANTUM® Patient Specific Instrumentation (PSI) System
- K211993 — Z-LINKPC System
- K212204 — Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
- K201026 — sOLVe Tube
- K210730 — Nitrile Patient Examination Glove
- K210820 — EAGLE EDGE AXR90 and AXR120
- K211414 — KHEIRON Spinal Fixation System
- K211640 — Ponto 5 Mini
- K211799 — Biodentine XP 500, Biodentine XP 200
- K211873 — PSX Interbody System
- K211030 — EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
- K211299 — X-CUBE 70
- K211300 — X-CUBE 90
- K211540 — Edma Synthetic Nitrile Examination Gloves
- K211354 — Disposable Synthetic Vinyl Nitrile Examination Glove
- K200193 — Kisses Plus Implant System
- K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity
- K203305 — Tiger Reusable Sharps Container
- K210320 — ClearCorrect System
- K210541 — ulrichINJECT CT motion
- K210725 — Nitrile Patient Examination Glove
- K211202 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
- K211435 — PAO Cortical Screw
- K211725 — Senographe Pristina
- K211764 — Vereos PET/CT
- K211783 — TriMed Threaded Intramedullary Nail System
- K211784 — da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
- K212100 — Kosmos
- K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
- K201089 — ARK Lacosamide Assay
- K202621 — NeuroSENSE Monitoring System, Model NS-901
- K202969 — Biomet Microfixation OmniMax MMF System
- K203006 — R2 Dermabrasion Tip (for Dermal Cooling System)
- K203362 — TRACOE vario
Data sourced from openFDA. This site is unofficial and independent of the FDA.