FDA 510(k) clearances — page 191
clearances on record, most recent first.
Clearances — page 191
19,001–19,100 of 176,479- K200612 — R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
- K200992 — S.I.N. Dental Implant System
- K201998 — JETi AIO Peripheral Thrombectomy System
- K202307 — Activ Fuse
- K202444 — Knotless TensionTight Button Implant System
- K202777 — VeriFixx Small Bone Implant
- K202931 — Disposable Trocar
- K193193 — Telio CAD Abutment Solutions- extra systems
- K200461 — Freeprint denture
- K200706 — Sientra OPUS Silicone Gel Breast Implant Sizer
- K201060 — Cordiana Dx16
- K201918 — EVOS Large Fragment Plating System
- K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- K202344 — TiUltra Implants and Xeal Abutments
- K202370 — Ion Endoluminal System
- K202490 — Avid CT2
- K202758 — Nd: YAG Laser Therapy Systems HM-YL900
- K202762 — Circular Fixation with Balanced Cable Transport
- K203149 — M.U.S.T. MINI Posterior Cervical Screws System
- K200401 — Apogee
- DEN190029 — Acumen Assisted Fluid Management (AFM) Software Feature
- K192612 — Kerecis Gingiva Graft
- K200081 — NEUWAVE Microwave Ablation System and Accessories
- K200239 — Astroglide Organix Gel
- K200820 — SpeediCath Compact Set
- K201666 — SINGLE USE MANOMETER
- K201881 — CoroFlow Cardiovascular System
- K201937 — Ceramir Restore QuikCap
- K202132 — Venue
- K202178 — VersaLoop Anchor System
- K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
- K202355 — Stryker Omega PEEK Knotless Anchor System
- K202373 — APEX 3D Total Ankle Replacement System
- K202620 — FlexCath Advance Steerable Sheath and Dilator
- K202966 — SIGNA Architect
- K203011 — Monster Screw System
- K203040 — TSolution One Total Knee Application
- K191433 — AGILON® XO Shoulder Replacement System
- K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer
- K192980 — EOGas 4 Endo-SteriTest
- K193289 — FastStroke, CT Perfusion 4D
- K193385 — TP Orthodontics Clear Aligner System
- K193411 — O2asis Personal Oxygen Humidifier
- K200334 — AN1036 Dosimeter
- K200335 — Sterisheet Sterilization Wrap
- K200336 — Tyvek Sterilization Pouches with Chevron Seal
- K201523 — Sharps container
- K201568 — Calvary Spine Pedicle Screw System
- K201985 — KardiaAI
- K202074 — Apache Ultrasound System (Model C62)
- K202571 — da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories
- K203082 — Insight Infrared Video Goggles
- K203085 — NOVA Patient Warming System
- K203173 — ExacTrac Dynamic
- K203043 — Route 92 Medical 070 Access System
- K183044 — JTK Dental Implant System
- K193214 — WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
- K200098 — VagiVital Aktivgel
- K200428 — Multi-Drive Interference Screw System
- K200886 — StimSite
- K201976 — SnapshotNIR
- K203106 — Nio Fusion 12MP (MDNC-12130)
- K193190 — BD PureHub Disinfecting Cap
- K193432 — Vantage PSI System
- K200005 — Concinnity Aligners
- K201269 — Accula Strep A Test
- K201431 — OGYILI TENS/NMES Stimulator
- K201990 — DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System
- K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
- K203110 — iFuse Implant System - iFuse Navigation
- K203128 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
- DEN200033 — NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
- K192621 — Medical RF
- K193562 — AI-Rad Companion Organs RT
- K200077 — BioMin Restore Plus
- K200672 — Durex Penck Standard, Durex Penck XL
- K200750 — Neuro.Al Algorithm
- K200811 — cobas u 701 microscopy analyzer
- K201091 — V-Print splint
- K201669 — SimpleSENSE
- K202427 — Aqueduct 100 Plus Cervical Dilation Balloon Catheter
- K202583 — BioShield biopsy valve EUS - Linear
- K202587 — ATEC Lateral Interbody System
- K202589 — APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System
- K202664 — Clio Prime and Clio Pedo
- K203061 — Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS) +2 more
- K203076 — Mecta-C Stand Alone Extension
- K200017 — Eclipse DermaFlex Cannula
- K201741 — Gabriel 3 Way EnFit Valve
- K201827 — GR-17 Resin System
- K201877 — OtoSet- Ear Cleaning System
- K201902 — MammaPrint
- K202244 — SPY-PHI System with SPY-PHI Fluorescence Assessment Software
- K202476 — Salvo® Spine System
- K203025 — LOBO Vascular Occlusion System (model LOBO-5)
- K203154 — KASILOF Cervical Plate System
- K182084 — Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
- K193499 — DigiGuide System
- K200350 — MyHip Planner & Verifier
- K201840 — Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Data sourced from openFDA. This site is unofficial and independent of the FDA.