FDA 510(k) clearances — page 71
clearances on record, most recent first.
Clearances — page 71
7,001–7,100 of 176,479- K241518 — Horizon® 3.0 TMS Therapy System (3 models)
- K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) +1 more
- K241585 — uMI Panorama
- K241602 — Kingcera Dental Zirconia Blank
- K241662 — Ultrasound Transducer Cover
- K241823 — ToxiSeal Vial Adaptor
- K241847 — Imbio PHA (4.0.0)
- K241957 — Talee, Talee PostOp
- K242249 — Conformity Stem Extension Line
- K242275 — syngo.via MI Workflows; Scenium; syngo MBF
- K242300 — MI View&GO
- K220908 — Ensol EnTM Specimen Collection and Transport System
- K233826 — Kosmos
- K240105 — Navigator (FMNVG15); Navigator XL (FMNVX06)
- K241227 — RHYTHMIA HDx Mapping System
- K241400 — SkinPen Precision Elite System
- K241881 — IPL Hair Removal Device (JM-843, JM-865, JM-638)
- K242243 — Target Detachable Coils
- K242280 — Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
- K242296 — VersaTap Suture Anchor (ADP050) +4 more
- K242346 — Grass® MR Conditional/CT Cup Electrodes
- DEN230067 — Chronos®
- K232991 — BT-1000
- K233816 — REDEMPTION Charcot Plating System
- K233827 — OxiWear
- K240078 — Fogarty Thru-Lumen Embolectomy Catheter
- K240545 — GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)
- K241457 — Vista BC Putty
- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K241557 — Cercon® yo ML
- K241913 — da Vinci Handheld Camera
- K241932 — OSSIOfiber® Compression Staple
- K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
- K242316 — Safety Lancet
- K233846 — Vitrification Solution Set and Warming Solution Set
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K240270 — Electric wheelchair (S7018)
- K241228 — TENSWave
- K241241 — Z1 Cemented Hip System
- K241354 — Sealer Solvent
- K241517 — Q Guidance System; Mako Spine System
- K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201)
- K241684 — Overjet Charting Assist
- K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
- K242537 — BracePaste Fluoride Sealant
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K240982 — DESS Dental Smart Solutions
- K241538 — TriClip Steerable Guide Catheter
- K241607 — MyoStrain (6.0)
- K241777 — SmartAdjust Technology
- K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K241858 — BARS Set (100.60)
- K242044 — FiAPC plus probes
- K231100 — Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
- K233358 — SCoV-2 Ag Detect Rapid Test
- K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K233829 — Nova Micro Pillows Mask Small A Model (NVP1SA) +7 more
- K240318 — SITTER 3.5mm Versatile System
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.