FDA 510(k) clearances — page 280
clearances on record, most recent first.
Clearances — page 280
27,901–28,000 of 176,542- K170983 — NIOX VERO
- K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS)
- K172007 — CamX Triton HD Proxi Head
- K172111 — Vevazz LED
- K172128 — EsoFLIP® ES-310 Balloon Catheter
- K172229 — GC85A
- K172278 — Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
- K172398 — DENTCA DENTURE Teeth
- K172424 — Velofix SA Cervical Cage
- K172462 — OrthAlign Plus System
- K172539 — CereTom Elite
- K172569 — GenePOC CDiff
- K172576 — BioHorizons Tapered Short Implants
- K172695 — AIR Anterior Array, AIR Posterior Array
- K172822 — Azurion series R1.2
- K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
- K172903 — HemosIL D-Dimer HS 500
- K173183 — CEDIA Heroin Metabolite (6-AM) Assay
- K163414 — Ultrasonic scaler
- K163579 — KLS Martin Individual Patient Solutions
- K170236 — Dental Low-speed Turbine Handpiece
- K170398 — S.I.N. Dental Implant System
- K170545 — Automatic Wrist Bluetooth Blood Pressure Monitor
- K170754 — 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
- K170914 — TXM Support Catheter
- K170915 — TXM Hydrophilic Guidewire
- K171044 — Climax Personal Lubricant
- K171073 — Smith & Nephew, Inc. REDAPT Augments
- K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece
- K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzer
- K171681 — Hermes Medical Imaging Suite v5.7
- K171719 — Hybrid3D
- K172050 — Follicle Aspiration Set, Reduced Single Lumen
- K172176 — Parkell Universal Adhesive
- K172218 — MIM Y90 Dosimetry
- K172253 — Altus Spine Cervical Interbody Fusion System
- K172622 — Microcyn Antimicrobial Skin and Wound Cleanser
- K172685 — LiverMultiScan
- K172924 — GentleCath Intermittent Urinary Catheter
- K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
- K173030 — Vertera Spine Cohere Cervical Interbody Fusion Device
- K173037 — Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
- K173112 — LAP-iX
- K171136 — LIA Pregnancy Test
- K171492 — B7 2C Occlusion Balloon
- K172032 — Modulift Vertebral Body Replacement (VBR) System
- K172241 — Tyece OTC EMS System, Model EM35
- K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K172580 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
- K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K172650 — Materialise PKA Guide System
- K172921 — Stryker Self-Punching ICONIX
- K172984 — Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
- K173018 — MDR17 Mobile Direct Radiographic System
- K173044 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
- K173169 — Rapid Family
- K173378 — syngo®.via protoNeo (Version VA20)
- K170544 — Langston dual lumen catheter
- K170856 — CMS600P2 B-Ultrasound Diagnostic System
- K171121 — Masimo Root Monitoring System and Accessories
- K171158 — Single Use Electrosurgical knife
- K171270 — DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
- K171589 — AEON Endoscopic Stapler
- K171742 — N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
- K171743 — Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
- K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
- K172223 — SleepRight ProRx Custom Dental Guard
- K172318 — Endoform Silver Dermal Template
- K172362 — DEKA SMARTXIDE TOUCH
- K172363 — DEKA SMARTXIDE ULTRASPEED
- K172451 — Dr.MUSIC 3s
- K172472 — Micro-MEC 1.8% Glutaraldehyde Monitor Strip
- K172514 — Trak Plus Male Fertility Testing System
- K172660 — Duravess bovine pericardial vascular patch
- K172761 — New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
- K172850 — SterilContainer with PrimeLine Pro Lid
- K172878 — Vantage Titan 3T, MRT-3010/A7, M-Power GX
- K173023 — Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
- K173068 — Performer Introducer
- K173305 — NeuroBlate System
- K173355 — Gastric Sizing Balloon Catheter
- K173365 — Bausch + Lomb Boston Scleral Lens Case
- K173423 — MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
- K173446 — Contour 24
- K163472 — Intra.Ox Handheld Tissue Oximeter
- K163643 — SIRIO H3
- K170022 — Klockner Vega TiBase for CEREC
- K170517 — Merits Model R106/R136 Rehab Wheelchair
- K170606 — Acrylic Herbst Appliance with Micro-Recorder
- K171254 — LeEject 2 Dental Syringe and Needle System
- K171482 — NEPHROCHECK Test System
- K171543 — Renovis Surgical Hip Replacement System
- K171610 — MC3 QuickFlow Dual Lumen Catheter
- K171618 — Symetrex Long Term Hemodialysis Catheter
- K171816 — Kardia Band System
- K172130 — Resorbable Mesh Device
- K172178 — Minimally Invasive Bunion Plating System
- K172535 — Bipolar applicator CELON ProCurve V
- K172550 — OEC Elite
- K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Data sourced from openFDA. This site is unofficial and independent of the FDA.