FDA 510(k) clearances — page 255
clearances on record, most recent first.
Clearances — page 255
25,401–25,500 of 176,542- K180894 — Magnetic Surgical System
- K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- K181229 — TirboLOX-C Cervical IBFD
- K181328 — T2 STRATOSPHERE Expandable Corpectomy System
- K181349 — Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens +1 more
- K181449 — Ortoma Treatment Solution - OTS
- K181734 — Beurer IPL 8500 device/ IPL VelvetSkin Pro
- K182080 — Scope Antifogging System
- K182286 — Oh'Care Lite Smart Blood Glucose Monitoring System
- K171904 — Tandry Locking Plate System
- K173830 — MAC VU360 Resting ECG Analysis System
- K181233 — Elecsys FT4 III
- K181320 — Caprolon
- K181337 — Sypher Spacer System
- K181390 — Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
- K181620 — Endoscopic Linear Cutting Staplers and Loading Units for Single Use
- K181653 — Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
- K182157 — BioSign Flu A+B
- K182243 — The CVC WAND Safety Introducer with Valved Peelable Sheath
- K173871 — CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- K180933 — DenTek Ultimate Dental Guard
- K181632 — Venacure 1470 Pro
- K181721 — Ceracell Ortho Foam
- K182260 — PALACOS MV
- K181102 — ThermaCare Quick Therapy TENS
- K173676 — A-FIT
- K173827 — LightScalpel
- K173910 — Impress SFS System
- K173926 — DORADOnova MR3T
- K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
- K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
- K180871 — Portable Nebulizer
- K180875 — POLY REJUV
- K181598 — Prime E-CLASS XLPE Liner
- K181874 — MX40 Mobile Digital X-ray System
- K182213 — QT Ultrasound Breast Scanner - 1
- K182214 — DizzyDoctor System 1.0.0
- K182223 — Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
- K172450 — TENS device-HeadaTerm, eEspress
- K173933 — Sorrento Bioglass Bone Graft Substitute
- K180053 — Sof-Flex Ureteral Stent Set
- K180215 — DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
- K181000 — SelectFlex 072 Neurovascular Access System
- K181236 — HySil Impression Materials
- K181241 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K181576 — Planmeca Viso
- K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module
- K181821 — MOSS VRS Spinal System
- K181889 — MTS Penicillin 0.002- 32 µg/mL
- K182206 — RiX70 DC
- K182275 — Seal Single Use Biopsy Valve
- K173424 — BioSphere Flex
- K181255 — PRODENSE Bone Graft Substitute
- K181748 — Magnesium
- DEN180042 — Irregular Rhythm Notification Feature
- DEN180044 — ECG App
- K171532 — TruBase S
- K173822 — Anchor Tissue Retrieval System by CONMED
- K181380 — LnK Lumbar Interbody Fusion Cage System
- K181504 — Stryker Pediatric Mandibular Distractor 2
- K181568 — IPL Salon Hair Reduction System
- K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System
- K182196 — Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
- K182226 — AirStrip RPM InvisionHeart Adapter
- K182232 — Octane Mechanical Thrombectomy System
- K173941 — IntelliSpace Perinatal Rev.K.00
- K181078 — The Sex Gel
- K181211 — Human Tecar HCR 1002
- K181415 — XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
- K181455 — ProSun sunlamp products, Luxura sunlamp products
- K182055 — SECULOK ACP System
- K170702 — mediCAD 4.0
- K173813 — IPL Hair Removal Device Joy Version
- K173883 — External Fixation System
- K180778 — Exceed Microneedling Device
- K181061 — Corin Optimized Positioning System (OPS) Femoral
- K181270 — Disposable SpO2 Sensors, Reusable SpO2 Sensors
- K181311 — Philips Hemodynamic Application R1.0
- K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
- K181525 — INNOVANCE Free PS Ag
- K181537 — GLOW800
- K181688 — R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
- K181811 — ReTrace Ureteral Access Sheath
- K182053 — Ultravision Visual Field Clearing System
- K182079 — Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
- K182144 — Bi-Flex Evo
- K182147 — CTXX85
- K182148 — SILVERBACK Gorilla Plating System
- K182208 — syngo.via View&GO (Version VA10A)
- K182230 — Multi Modality Viewer
- K182263 — RetCam 3; RetCam Shuttle; RetCam Portable
- K172834 — Dual output digital therapy massager
- K173893 — Trabis
- K180465 — Provata Implant System
- K180728 — Spinal Elements Cerclage System
- K181128 — Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
- K181518 — Sebacia Microparticles
- K181558 — Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
- K182153 — Ultrasound System SONIMAGE HS1
- K182234 — Optima XR240amx
Data sourced from openFDA. This site is unofficial and independent of the FDA.