FDA 510(k) clearances — page 247
clearances on record, most recent first.
Clearances — page 247
24,601–24,700 of 175,699- 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
- K173665 — AMSafe Sure-Lok Needle-Free Connector
- K173921 — HD-500 Video Endoscope System
- K173976 — Masimo Acoustic Respiration Sensors, infant and neonate
- K181662 — Iridex TruFocus LIO Premiere
- K181878 — Kiierr 272 Laser, Kiierr 148 Laser
- K182138 — Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
- K173568 — NeoBase 2 Non-derivatized MSMS Kit
- K173765 — Surveyor Patient Monitor
- K181249 — EUSRA RF Electrode
- K181314 — IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
- K181510 — ECHOLASER X4
- K181532 — Exactech Alteon Monobloc Revision Stem
- K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
- K181167 — Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
- K181466 — Cadwell Zenith System
- K171549 — Intelligent Mesh Nebulizer
- K173368 — Reusable & Disposable SpO2 Sensors
- K173477 — ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
- K180006 — AmCAD-UT Detection 2.2
- K180185 — BIO-C REPAIR
- K180866 — CareSens S Fit Blood Glucose Monitoring System
- K181225 — ALTAPORE
- K181228 — IlluminOss Bone Stabilization System
- K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
- K181482 — myTAP2
- K181543 — Cure OPEL-C Plate System
- K182107 — CarriGen PF
- K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
- K173380 — b-ONE® Total Hip System
- K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set
- K173623 — Anchor plate
- K173648 — Spectralis HRA + OCT and variants
- K180536 — Neodent Implant System GM Line
- K180888 — LYFT
- K181262 — SpineJack Expansion Kit
- K181486 — DEKA Motus AY
- K181513 — Arthrex PushLock Tenodesis Anchor
- K181997 — Swiss LithoClast Trilogy
- K182024 — Dissecting Balloon System
- K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
- K173205 — Equinox Advantage
- K180073 — Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set
- K180496 — TruClear Elite Hysteroscope
Data sourced from openFDA. This site is unofficial and independent of the FDA.