FDA 510(k) clearances — page 63
clearances on record, most recent first.
Clearances — page 63
6,201–6,300 of 175,620- K240593 — VEEGix EEG System
- K240790 — Polyisoprene Surgical gloves
- K240896 — ONE Nitrile Condom
- K241302 — SonoSync
- K241492 — Guided Surgery Kit Cases
- K241780 — Cardinal Health Nitrile Exam Gloves
- K242169 — Morph DNA Steerable Introducer Sheath
- K242191 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K242202 — LightWalker Laser System Family
- K242264 — TMINI Miniature Robotic System
- K230071 — Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
- K234076 — iCare ALTIUS CW
- K234128 — Phantom Fibula Nail System
- K240227 — LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
- K241098 — NeuroQuant
- K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories
- K241369 — LIJIA Night Guard
- K241803 — INSULCLOCK® v2.0 PRO
- K241804 — TRIGEN INTERTAN 10S Nail System
- K241979 — Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
- K242126 — I.V. Administration Set
- K242248 — Introducer Sheath Kits
- K232415 — Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K233391 — cCeLL - In vivo
- K233566 — Montage-XT Settable, Resorbable Bone Putty
- K240290 — AiMIFY (1.x)
- K240298 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
- K240314 — MULA (K2-A1)
- K240859 — Glidewire GT-R
- K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100)
- K241080 — Kerecis Parvus (50207)
- K241351 — Blood Pressure Monitor (TMB-2092-G)
- K242066 — iSage Rx
- K242141 — TiLink-P SI Joint Fusion System
- K242142 — Fraxel® FTX Laser System
- K231932 — TDS (TECHWIN DENTAL SYSTEM)
- K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K240200 — HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
- K241102 — Luna 4 plus
- K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic)
- K241496 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
- K241738 — PYXIS 3D Titanium Cervical Cage system
- K241848 — MedtFine Safety Lancet
- K242134 — ClearCap Distal Attachment
- K242189 — CELERITY HP Indicator Tape (PCC077)
- K240235 — OmniTrans Transport System
- K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand)
- K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3)
- K241282 — RibFix Titan Fixation System
- K241440 — HealthCCSng
- K241504 — iFuse TORQ TNT Implant System
- K241870 — OnPoint Augmented Reality Spine System
- K242432 — MT-Bone
- K240234 — BTL-899MS
- DEN230090 — First To Know Syphilis Test
- K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K223700 — BOSS
- K231979 — Mecun SpO2 sensor
- K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter
- K233700 — Avicenna Roboflex
- K233755 — HeartKey® Rhythm
- K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
- K240081 — Human Lubricant
- K240133 — Xenograft Bovine Bone Particulate
- K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
- K240573 — iTero Lumina Pro
- K240740 — qCT LN Quant
- K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K241236 — XTRA Collection sets; XTRA Sequestration set X
- K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)
- K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance
- K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- K233505 — Sapphire ULTRA Coronary Dilatation Catheter
- K233965 — UltraDrape UGPIV Barrier and Securement (34-15)
- K240837 — TOV Dental Implant System
- K240961 — Disposable Pen Injector Assembly
- K241211 — CoLumbo
- K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K241522 — NPseal (20 and 25)
- K241596 — uMI Panvivo
- K241750 — Medifun Safety Lancet ( MSL1 series)
- K241754 — NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate
- K241810 — MICROLET®NEXT Lancet
- K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002)
- K232836 — Family of DIMAR DMAX NIV masks
- K240595 — Utepreva Endometrial Sampler (UP01)
- K240713 — TRAUMAGEL®
- K240957 — Catapult Guide Sheath
- K241510 — CROSSLEAD Tracker
- K241571 — BostonSight® Specialty Lenses
- K241748 — Intimate Rose Vaginal Dilators
- K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
- K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- K242059 — Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
- K242077 — PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
- K240807 — VM-2000
- K241094 — Bullsai
- K241387 — CoLink NeoFuse MIS Plating System (see attached parts list)
Data sourced from openFDA. This site is unofficial and independent of the FDA.