FDA 510(k) clearances — page 187
clearances on record, most recent first.
Clearances — page 187
18,601–18,700 of 176,479- K201872 — NeutrArt
- K202791 — iHealth Clinical Digital Thermometer
- K202857 — ClearPath Aligner
- K202719 — Disposable Medical Face Masks
- K202880 — J-Plasma Precise FLEX Handpiece
- K203561 — ChoiceSpine Navigation System
- K201873 — Sparrow Therapy System
- K201239 — NuEra Tight Family, EMS Model
- K201342 — HANAROSTENT Trachea/Bronchium (CCC)
- K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
- K202322 — Sim&Size
- K202615 — Nordiwell Medical Face Mask
- K202681 — Promisemed Covered Safety Pen Needle
- K202706 — Surgical Gown (Sterile), Surgical Gown (Non-sterile)
- K193159 — NeuroAmp II, NeuroAmp II.5s
- K201754 — JianYu Surgical Mask
- K201776 — Foley Balloon Catheter for Urology
- K202038 — CryoTreQ
- K202268 — CrossRoads Tray System
- K202372 — Upper Arm Electronic Blood Pressure Monitor
- K202690 — Remunity Pump for Remodulin (treprostinil) Injection
- K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K203239 — Arthrex Low Profile Screws
- K200965 — XR-MX/1000
- K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
- K202456 — M5 Recorder
- K202699 — E-Cath STIM acc. Tsui
- K202940 — First Relief v1
- K203137 — Venue Fit
- K203219 — Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever
- K203508 — BriefCase
- K203511 — Baby Gorilla/Gorilla Plating System
- K200321 — Novaerus NV1050
- K200458 — Tailored-C Cervical Interbody Fusion System
- K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
- K200970 — Self-Contained Biological Indicator
- K201781 — Uni-FuZe-P Bone Putty
- K201800 — Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
- K202248 — Attune Revision Sleeve LPS Femoral Adaptors
- K202454 — Smart SPACE Shoulder System
- K202730 — Quadra-P
- K203062 — Optiflux Series of Dialyzers F160NR, F180NR, F200NR
- K193419 — MBT Sepsityper
- K201747 — 8-CH Electroencephalography Amplifier
- K202485 — ImPACT Version 4
- K200422 — Image Quality Analyzer (IQA)
- K200426 — Acute Dual Lumen Hemodialysis Catheter
- K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
- DEN190035 — Helix Laboratory Platform
- DEN200016 — EndoRotor Device
- K192073 — Helix Genetic Health Risk App for late-onset Alzheimers disease
- K193670 — SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
- K200610 — Customized Contour Implant
- K200631 — DeRoyal Temperature Monitoring Probe
- K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
- K201458 — Scrambler Therapy Technology (Model ST-5A)
- K201604 — Plasdent Disposable Barrier Sleeves and Barrier Film
- K202061 — Medical Face mask
- K202237 — Locking device
- K202320 — CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
- K202353 — SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
- K202431 — ControlRad Select Model Z
- K202526 — OmniTom Elite
- K202637 — F3D Corpectomy System
- K202882 — Affinity
- K203026 — AltiVate® Anatomic Pegged Glenoid with Markers
- K203207 — Omnia Medical TiBrid-SA
- K203257 — LUBi Water Based Personal Lubricant
- K203467 — WishBone Medical Plate and Screw System
- K203540 — Bridge Occlusion Balloon
- K200473 — SoloAsisst II, Voice Control
- K200908 — iSMILE
- K201036 — PlaniMax Orthodontic Software
- K201287 — Impulse Interbody Fusion System
- K201489 — Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
- K201491 — Neodent Implant System - Zirconia Implant System
- K201643 — ChoiceSpine Tiger Shark Cervical Spacer System
- K201705 — ReVene Thrombectomy Catheter
- K201707 — Opallis, Opallis Flow
- K201910 — EZTrack
- K202159 — actiTENS
- K202211 — Disposable Medical Surgical Face Masks
- K202229 — AI Metrics
- K202298 — Lucent XP, Lucent XP Curved
- K202348 — External Remote Controller ERC 4P
- K202820 — Australis Anterior Lumbar Cage System
- K202849 — Everyway Analog OTC TENS, model N103A/N302
- K202968 — Da Vinci SP Surgical System
- K202974 — DenTek Fresh Protect Dental Guard
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
- K203281 — Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
- K203437 — Serranator PTA Serration Balloon Catheter
- K203447 — iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
- K203452 — Nano FortiFix® System
- K203476 — CAPERE Thrombectomy System
- K203504 — Cios Flow
- K203552 — Rapid Reboot
- K192308 — Wu's Electrical Scooter
- K201113 — Resascope RS-01/B
- K201996 — Monocryl Plus Antibacterial Suture
Data sourced from openFDA. This site is unofficial and independent of the FDA.