FDA 510(k) clearances — page 195
clearances on record, most recent first.
Clearances — page 195
19,401–19,500 of 176,479- K202522 — Synchro SELECT Guidewire
- K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
- DEN200002 — Tangible Boost
- K200115 — Cavetto-SA Cervical Cage System
- K200569 — RayStation
- K201051 — Straumann BoneCeramic
- K201260 — Dermal Cooling System
- K201684 — A-Silicone for Bite Registration
- K201770 — Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
- K202477 — EndoGI S-Path Biliary Stent System
- K202484 — Cordera Hip System
- K202572 — GXR-Series Diagnostic X-Ray System
- K193276 — Nerve and Muscle Stimulator
- K200414 — Pulse Oximeter
- K200416 — Boston One Step Liquid Enzymatic Cleaner
- K201208 — Halo AF Detection System
- K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
- K201367 — FlareHawk TiHawk9 Interbody Fusion System
- K202479 — IBS Implant System
- K202569 — Responsive Arthroscopy Interference Screw System
- K200123 — Accessories for the SixFix® Hexapod Fixator
- K200843 — Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
- K200987 — LTJ Screws and Washer
- K201717 — BD Cathena Safety IV Catheter
- K202210 — Vantage Orian 1.5T, MRT-1550, V6.0
- K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- K192707 — Optiflux F180NR Dialyzer
- K192814 — Pounce Thrombus Retrieval System
- K201278 — World Hip Stem, World Cup, World Liner
- K201290 — Medline DeNovo 4Pro Electrical Stimulation Device
- K201467 — Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
- K200603 — AAA Model
- K201350 — CORVUS
- K201532 — B&J DVT Calf/Thigh Garments, Models 801/830 Series
- DEN200010 — Spineology Interbody Fusion System
- K190798 — LaborView LV1000 Wireless Electrode System
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
- K192890 — SentEP
- K193368 — Smart Correction System
- K200174 — DIA-ROOT BIO MTA
- K200852 — EchoPAC Software Only, EchoPAC Plug-In
- K201013 — Optixon 1-Day
- K201073 — Seaspine WaveForm C Interbody System
- K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
- K201224 — Electrosurgical Generator and Accessories
- K201390 — Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
- K201538 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K201547 — B&J DVT Foot Garments, Models 820 Series
- K201642 — Paragon Adult Maxi PMP Oxygenator with Tubing Pack
- K201673 — SMS Cementless Stem
- K201746 — Tempus Pro Patient Monitor
- K201992 — Caption Guidance
- K202022 — GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
- K202287 — Ran-Flex-B Bone Marrow Aspiration Needle
- K202399 — OrthoButton FL
- K202463 — Disposable Surgical Mask
- DEN190032 — HemosIL Liquid Anti-Xa
- DEN190039 — ToothWave
- K182020 — Portable Electro-Stimulation Therapy Device
- K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)
- K201494 — ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
- K201686 — GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT Introducer and Catheter Guide, GYNECARE TVT EXACT Continence System and Trocar, GYNECARE TVT Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide
- K201691 — Single-Use Surgical Mask With Ear Loop
- K201849 — eNAT molecular collection and preservation medium
- K202007 — LZI Oxycodone III Enzyme Immunoassay
- K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System
- K200430 — Precice® Ankle Salvage System
- K200469 — PAPAYA 3D Premium & PAPAYA 3D Premium Plus
- K201298 — VX1
- K201369 — AVA (Augmented Vascular Analysis)
- K201661 — Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
- K201774 — Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
- K202286 — Tulsa-Pro System
- K202360 — Ziehm Vision RFD 3D
- K202394 — EOSedge
- K202406 — Butterfly iQ Ultrasound System
- K192665 — Accelerate Pheno System, Accelerate PhenoTest BC Kit
- K201170 — Athletis PTA Balloon Dilatation Catheter
- K201341 — AcQMap 3D Imaging and Mapping Catheter
- K201645 — Massage Compression Boots
- K201656 — ARIX Elbow System
- K201664 — FIREBIRD SI Fusion System
- K201665 — Collaboration Live
- K202347 — UNIFUSE Infusion System with Cooper Wire
- K200313 — VIVO
- K200343 — FusionFrame Ring Lock System
- K200862 — Feelix Stethoscope
- K201631 — VersaWrap Nerve Protector
- K201646 — Shoreline ACS (Anterior Cervical System)
- K202227 — Artus cervical plate system
- K202318 — Marathon Flow Directed Micro Catheter
- K193657 — Disposable Enteral Feeding Syringe with Enfit Connector
- K191639 — TK Insulin Syringe with/without Saftey Retractable Device
- K192137 — IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
- K193340 — GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
- K193449 — Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
- K200530 — AMICUS Separator System
- K200854 — DePuy PINNACLE Dual Mobility Liner
- K200948 — Fitbit ECG App
Data sourced from openFDA. This site is unofficial and independent of the FDA.