FDA 510(k) clearances — page 263
clearances on record, most recent first.
Clearances — page 263
26,201–26,300 of 176,542- K172981 — Reusable SpO2 Sensors, Disposable SpO2 Sensors
- K173070 — HSW Resection Instruments
- K173156 — Integrated CardioRespiratory System
- K173189 — Lumfuse TP
- K173706 — Piccolo Implants and Accessories
- K180306 — Nexy
- K180332 — 17HK700G-W
- K180449 — Single Use Aspiration Needle NA-U200H
- K180660 — Avanti
- K180904 — Sniper Infusion Catheter with Balloon Occlusion
- K180985 — Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
- K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
- K172121 — Digital Thermometer
- K172721 — FOCAL ONE
- K172909 — ELEVARE, PERFECTIO 4
- K173032 — Paxman Scalp Cooler
- K173155 — Pakter Curved Needle Set
- K173573 — Tetric CAD
- K173577 — Guarded Luer Connector
- K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
- K180459 — VERASENSE for Zimmer Biomet Persona
- K180612 — Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
- K180839 — AT 030
- K180947 — Orthopantomograph OP 3D
- K180956 — Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
- K181264 — QLAB Advanced Quantification Software
- K172221 — VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
- K172780 — SD1 Ultrasonic Pocket Doppler
- K173053 — POWDER FREE LATEX EXAMINATION GLOVE
- K180427 — ARK Fentanyl Assay
- K180436 — T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
- K180621 — EchoMark, EchoMark LP
- K180672 — Sterilization Pouch/Roll Made with Tyvek
- K180709 — truSculpt RF Device; truSculpt; truSculpt 3D
- K180712 — Coconut Infused Hybrid Personal Lubricant
- K180832 — SALVATION External Fixation System
- K180925 — uMR 570
- K180926 — uMR 560
- K181202 — Sentry IVC Filter
- K181207 — Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
- DEN170089 — Curve Positive Airway Pressure System
- K172745 — ImmuGlo HEp-2 Elite IFA
- K173045 — Oximeter
- K173093 — TAMA BEMS device
- K173821 — LungQ Software
- K173961 — Straumann BLX Implant System
- K180191 — SuperBall Meniscal Repair System
- K180593 — Vbeam Prima Laser System
- K180608 — Lunoa System
- K180661 — SIGMA Sterilization Pouch and Roll
- K171609 — Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
- K172763 — Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
- K172807 — Silicone Foley Catheter for single use
- K180447 — reVive Light Therapy LED Cleansing System
- K180500 — VariAx 2 System
- K180640 — SmartClip Soft Tissue Marker
- K181012 — BUHLMANN fCAL ELISA
- K171798 — Silverwear Silver Pro Garment Device
- K172068 — Kenz Cardico1211
- K172234 — Oxygen Concentrator
- K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
- K172499 — NEOSHIELD
- K172765 — Smart Moves Complete
- K173330 — PanNAT STEC Test
- K173975 — UF(II) Wide Fixture
- K180026 — Bowel Management Device, Bowel Management Irrigation Set
- K180045 — Omnipod DASH Insulin Management System
- K180136 — BioNude Lubricant
- K180189 — InMode System with Fractora3D/3D-90 Applicators
- K180238 — CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
- K180325 — Single Use MultiClip Device
- K180617 — Hair Up
- K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit
- K180855 — Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
- K170703 — Single Use Arthroscopic Electrode (with Pencil)
- K171828 — ETCO2 Sensor
- K172690 — ToFscan
- K173415 — EndoWrist 5mm Thoracic Grasper
- K173906 — da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- K180464 — AEVUMED PHANTOM Suture Anchors
- K180480 — ATEC Universal Spacer System
- K180582 — Sternal Cable System
- K180606 — SOMAVAC Device
- K181098 — ACUSON SC2000 Diagnostic Ultrasound System
- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K181177 — Interventional Workspot
- K171019 — ScioCardio ECG Transmitter
- K172825 — MN-111
- K173246 — ANEROID SPHYGMOMANOMETER
- K173269 — KATOR Suture Anchor
- K173483 — Pure Flow External Counter-Pulsation Device
- K173951 — Legend Acetabular Liners
- K180167 — Playtex Stella Tampons
- K180293 — Retia 2
- K180361 — MICRORAPTOR REGENESORB Suture Anchor
- K181188 — EVEREST Spinal System
- K172871 — SpineKure Kyphoplasty System
- K173157 — Dr's Light2
- K180174 — Belun Ring
Data sourced from openFDA. This site is unofficial and independent of the FDA.