FDA 510(k) clearances — page 182
clearances on record, most recent first.
Clearances — page 182
18,101–18,200 of 175,699- K202069 — BASE4 Disposable Medical Mask
- K202377 — Palm Care Latex Examination Powder Free Gloves
- K202388 — Apolo D / Apolo S
- K202659 — Stryker Arthroscope
- K202876 — Confirm Rx Insertable Cardiac Monitor
- K203199 — RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
- K200155 — Bright High Flow
- K200372 — Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil
- K201687 — Avenda Health Treatment System
- K202416 — Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
- K201173 — E-Guard
- K201294 — Pulse Oximeter
- K201308 — Axonpen, Axonmonitor, Axonbox, Tablet
- K201653 — Compex Sport Elite 3.0
- K202851 — Spo2 Sensor
- K203268 — Arthrex FiberTak Suture Anchor
- DEN200029 — Parallel
- K192177 — SysMed S/T
- K192285 — CPR Face Shield
- K192406 — AveCure BT Microwave Ablation System
- K193155 — Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
- K193377 — TopLock Anchor System
- K200402 — DR-HO'S Electro Therapy Conductive Gel
- K200484 — CARTO® 3 EP Navigation System with Signal Processing Unit
- K200761 — Tenax Laser Resistant Endotracheal Tube
- K201193 — SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System
- K202066 — EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled
- K202079 — Physiq
- K202098 — GLOBAL UNITE Platform Shoulder System
- K202194 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- K202250 — Dermatological Carbon Dioxide Laser Systems
- K202269 — PRE-MILLED Abutment
- K202306 — T3 Platform software
- K202465 — Night Guard
- K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
- K202883 — Sterile bone screw (PEEK ACL screw)
- K203216 — The Multimodality Advanced Vessel Analysis
- K203317 — CarboClear X Pedicle Screw System
- DEN190047 — CADScor System
- K193158 — ACENT Central Venous Catheter
- K200798 — G-CEM ONE
- K200931 — RF Surgical Generator
- K201622 — Medical surgical mask
- K201742 — eKuore One Wireless Electronic Interface for stethoscope
- K201904 — Monet Curing Laser
- K202515 — NUVO Implant System NUVO Instrument Kit Cases
- K202682 — Promisemed Triple Safety Pen Needle
- K202943 — OptoMonitor 3
- K202959 — PolyLock Plating System
- K202972 — Anterior Cervical Plate System
- K203024 — C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- K203081 — RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
- K203120 — RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
- K193621 — Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
- K200166 — Mirus Ligating Clip, Mirus Ligating Clip Applier
- K201484 — Somnos Anti-Snoring Mouth Guard
- K201991 — Medical surgical mask
- K202475 — PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
- K202888 — Confirm Rx Insertable Cardiac Monitor
- K203056 — Invictus Spinal Fixation System
- K202090 — Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
- DEN200043 — FilmArray Global Fever Panel
- K193056 — Puritan Bennett 980 Series Ventilator System
- K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
- K193285 — V-ONESTEP
- K193287 — CorInsights MRI
- K193346 — Codman Surgical Patties & Strips
- K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
- K200873 — HALO
- K201158 — NeuroStar Advanced Therapy
- K201325 — Optomed Smartscope M5 with Optomed Smartscope FA
- K201404 — Passio Pump Drainage System
- K201526 — TIPCAM1 Rubina Video Endoscope System
- K201815 — Dornier MAGELLAN Ureteral Access Sheath
- K201825 — MiniCAT 2D
- K201984 — MPS 3 ND Myocardial Protection System
- K202000 — Silatrix Oral Gel
- K202035 — Vscan Air
- K202042 — Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
- K202139 — Medical surgical mask
- K202382 — FilmArray Global Fever Panel External Control Kit
- K202413 — LC ResinCal PC
- K202529 — ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
- K202764 — Ortho Solutions Plating System
- K202805 — Optimized Positioning System (OPS) Insight
- K202962 — Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft
- K203100 — Arthrex Eclipse Titanium Humeral Head
- K203156 — DTX Studio Clinic
- K203169 — Revolution Ascend
- K203179 — Fortress Introducer Sheath System
- K192503 — GM501 Wash with Phenol Red and Gentamicin
- K192860 — Sapphire Infusion Pump, Sapphire administration sets
- K200171 — SMR TT Augmented Glenoid System
- K200580 — FotoDent denture
- K200693 — K2 MOBILE
- K201694 — Air Compression Therapy Device
- K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
- K202172 — StarWalker
- K202442 — Carewear Firefly Wrinkle Reduction
- K202980 — Laser Therapy Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.