FDA 510(k) clearances — page 173
clearances on record, most recent first.
Clearances — page 173
17,201–17,300 of 176,479- K203198 — KARL STORZ Metal Sterilization Trays
- K203309 — NUVO CF Implant System
- K203459 — SafeCross Transseptal Puncture and Introducer (TSP/I) System
- K210480 — AcuPebble SA
- K211821 — DEKA Motus AZ
- K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
- K202241 — LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
- K202570 — Insulin Syringe, Insulin Syringe with Safety Retractable
- K202954 — Disposable Surgical Mask
- K203347 — Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
- K203441 — The Alma Hybrid Laser System
- K203498 — LX9max
- K203591 — Single-use Medical Face Mask
- K203800 — SyntrFuge System
- K210097 — Estar-Z
- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K210199 — RICOH MEG
- K211393 — Selethru(TM) NC PTCA Balloon Dilatation Catheter
- K211422 — Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
- K202171 — Pulmogine Vibrating Mesh Nebulizer
- K203262 — Cannula for Organ Perfusion
- K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System
- K203575 — GlidePath Retro Long-Term Hemodialysis Catheter
- K203672 — MAZIC Claro CAD and MAZIC Claro Press
- K210326 — Bravo G4 Chamber Autoclave
- K210611 — MAGNETOM Free.Max
- K210910 — Snore Bandit
- K211007 — EZ-TRAXTM Persona Knee Containment Device
- K211337 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
- K211411 — Penumbra System (RED 68 Reperfusion Catheter)
- K211511 — decimal Bolus
- K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
- K201206 — Pivot Breath Sensor
- K203057 — Quantum Perfusion Arterial Cannula Graft
- K203717 — Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
- K210044 — Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
- K210377 — Stryker iBur hubs and cutting accessories
- K210512 — LUMINELLE DTx System
- K210542 — aprevo Transforaminal IBF
- K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- K210753 — KardiaMobile 6L
- K210904 — Metapaste Plus
- K211025 — Oral/Enteral Syringe with ENFit connector
- K211768 — LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
- K203645 — Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
- K203733 — 12MP Color Digital Mammography LCD Monitor CL-S1200
- K210437 — Standard Bougie, 38 Fr.
- K210445 — Nordiwell Surprotect Face Mask
- K210645 — RayStation 10.1
- K210837 — Smith & Nephew Plates and Screws
- K210843 — STAGE
- K210954 — Synergy
- K211038 — Biophotas Celluma RESTORE
- K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System
- K203410 — ENFit Disposable Enteral Syringe
- K210421 — Diafil & Diafil Capsule
- K210587 — Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
- K210775 — White Nitrile Powder Free Patient Examination Glove, Non Sterile
- K210869 — Phantom Hindfoot TTC/TC Nail System
- K201196 — Scooter (Model: FDB01)
- K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
- K203657 — Vu-Path Ultrasound System
- K210098 — PuraStat-GI
- K210138 — iTind System
- K210889 — iLab Polaris Multi-Modality Guidance System
- K211193 — BD Prevue II Peripheral Vascular Vascular Access System
- K211232 — Apache Ultrasound System
- K211238 — SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
- K211252 — Nitrile Glove
- K211293 — Safety Winged Blood Collection Sets
- K211656 — 3D Echo v1.1
- K201428 — Powder Free Black Nitrile Examination Glove
- K202196 — BioFire RP2.1/RP2.1plus Control Panel M441
- K202523 — TMJ Relax
- K202551 — Cor-Knot Micro
- K202897 — Natural Cycles
- K203375 — OVOMotion Reverse Shoulder Arthroplasty System
- K203590 — Perfit FS Dental Zirconia Fully Sintered Block
- K210423 — Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
- K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- K210909 — easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
- K210948 — Omnilux CLEAR
- K210959 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
- K211191 — Virtual C DRF Digital Imaging System
- K211259 — Renamel Bulkfill
- K211297 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K211306 — LABYRINTH
- K211623 — THD Procto Software System
- K201806 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter
- K203456 — Straumann CARES M-Series CAD/CAM System
- K203725 — S.I.N. Dental Implant System
- K210258 — NovoFine
- K211045 — Synthetic Vinyl Examination Gloves
- K211408 — CervAlign® Anterior Cervical Plate System
- K211595 — da Vinci SP Surgical System (SP1098)
- K211596 — CD Horizon Spinal System
- K211606 — Mariner Deformity System
- K211695 — Valkyrie Thoracic Fixation System
- K201935 — Air Pressure Therapy System
- K202991 — Fotona XPulse Pro Laser Platform
Data sourced from openFDA. This site is unofficial and independent of the FDA.