FDA 510(k) clearances — page 179
clearances on record, most recent first.
Clearances — page 179
17,801–17,900 of 175,699- K200560 — InBody
- K200769 — Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
- K200999 — Thermidas IR System (ThIR-A615)
- K202350 — SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
- K202491 — Disposable Surgical Face Mask
- K202495 — SIRION Lateral Lumbar Interbody Fusion
- K202594 — Medical Surgical Masks-Non Sterile
- K202810 — AutoStrut G2
- K202844 — Medical Surgical Gowns
- K203339 — NEOLab Clear Aligners
- K203340 — MULTIX Impact C
- K203465 — OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
- K203652 — Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
- K193273 — Insulin Syringe
- K193497 — Fixone Biocomposite Interference Screw
- K200159 — Non-contact Infrared Body Thermometer, model:HTD8823US
- K200298 — ABI Instrument, Creo Electrosurgical System
- K200491 — Bfix Orthopedic External Fixator Systems
- K200963 — Halo Single-Loop Microsnare Kit
- K201114 — Bidop 7
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.