FDA 510(k) clearances — page 66
clearances on record, most recent first.
Clearances — page 66
6,501–6,600 of 175,620- K212521 — Field Shield Wound Dressing
- K221495 — SOLID CLIP Single Use Clip Applier
- K233482 — Equinoxe® Central Screw Baseplate System
- K233768 — Papacarie Duo
- K233917 — ICHOR 7F Embolectomy System (ICH-7F)
- K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx
- K240340 — Surgical Drive System (Model: ES70, ES90, E8)
- K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
- K241060 — HardyDisk AST Cefiderocol 30µg (FDC30)
- K241206 — Quantum Perfusion Hybrid System
- K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K241321 — Juliet® Ti LL Lumbar Interbody Device
- K241463 — Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)
- K241879 — vRad Viewer
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K240503 — Sonata Transcervical Fibroid Ablation System 2.2
- K240609 — S.I.N. Dental Implant System
- K240705 — Vitrea Software Package, VSTP-002A V2.0
- K240845 — Rayvolve
- K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
- K241121 — MICSI-RMT
- K241413 — sagAlign Lumbar Cage System (Various PNs)
- K241467 — Stable-C Interbody System
- DEN230061 — allay Nerve Cap
- K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
- K240272 — Electric Scooter (M2085, S2091)
- K240944 — Swoop® Portable MR Imaging® System
- K241050 — CrossRoads Modular Tray System
- K241056 — Light Cure Adhesive
- K241441 — RadiForce RX670; RadiForce RX670-AR
- K241740 — Finesse Injectable PTA Balloon Dilatation Catheter
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel
- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K233449 — Avantik VTM
- K233458 — CM005 Standard (CM005); CM004 Mini (CM004)
- K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)
- K240178 — RFG-01
- K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00)
- K240616 — FAQ (102)
- K241032 — BellaTek Bars
- K241739 — Endoscopic Applicator, 41 cm
- K241751 — NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat
- K241385 — Omnifix Syringe NRFit
- DEN220042 — Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
- K233457 — RUS
- K233557 — HemoCare Hemodialysis System
- K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
- K233834 — Infinity Gateway Suite
- K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K234077 — SPIRA® Anterior Lumbar Spacers
- K234124 — Single Use Hemoclips
- K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems
- K240247 — MoFi Cell Culture Basal Medium
- K240651 — MRI Universal
- K240661 — Geistlich Bio-Oss®
- K240920 — HemoCare Bicarbonate Concentrate Set (BCS)
- K241018 — KLS Martin Orthopedic Implants - MR Conditional
- K241031 — TMINI Miniature Robotic System (TMINI 1.1)
- K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
- K241378 — S.I.N. Instrument Kits
- K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K241705 — MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)
- K241707 — OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL
- K241713 — HiRise (1040-230)
- K241715 — Dental Glass Ceramics Blocks (HT,LT,ST)
- K241720 — VersaCross Connect Transseptal Dilator
- K241727 — BriefCase-Triage
- K233791 — Drivewire 24 Guidewire
- K233874 — tmCMF Solution
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K241000 — ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;
- K241006 — Natural Cycles
- K241022 — Sterile single use tip cleaner (WK800-S10 , WK800-S20)
- K241329 — SubtleSYNTH (1.x)
- K241460 — Manual Wheelchair
- K241706 — MicroMatrix® UBM Particulate
- K241711 — Oscar Peripheral Multifunctional Catheter system
- K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix
- K232177 — Lightin System, Lightin, Lightin Generator
- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
- K233628 — AOS Interstitial Templates, Needles, and Accessories
- K240016 — IPL Hair Removal Device (YT01,YT02,YT03,YT04)
- K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
- K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
- K241426 — GPS Advanced; 5 cc GPS Advanced Cannula
- K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
- K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
- K232551 — EM-07 Cordless Endo Motor
- K233937 — OW100S
- K240610 — deepLive
- K240966 — Prima Plus Conical Implant System
- K241019 — aprevo® TLIF-C Articulating System
- K241316 — Zirconia Block
- K241343 — IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
- K241372 — Advisor HD Grid X Mapping Catheter, Sensor Enabled
- K233584 — RhythmStar System
- K240502 — da Vinci SP Surgical System (SP1098)
- K241293 — LED Light Therapy Device, ELIXIR MD
Data sourced from openFDA. This site is unofficial and independent of the FDA.