FDA 510(k) clearances — page 21
clearances on record, most recent first.
Clearances — page 21
2,001–2,100 of 176,479- K260112 — QuikFix External Fixator: Knee-Spanning Pack
- K260202 — LED Light Therapy Masks (LumiLips FAC07NA)
- K251937 — nordicAudio (1.0)
- K251950 — Endobronchial Blocker Tube (12 models)
- K251980 — ClaveQS Bag
- K252005 — Livi Device
- K252016 — Arthrex Humeral Nails
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- K252606 — Bifix Veneer LC, Bifix Veneer Try-In
- K253098 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
- K253520 — Photonova Spectra, Photonova Spectra Select
- K253574 — SOMATOM X.cite; SOMATOM X.ceed
- K253604 — TiLink-L Navigation Instruments
- K253849 — Electric wheelchair (JJW-7002, JJW-7003)
- K253864 — NOMAD Pro 3
- K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit
- K254208 — FLOWRUNNER Aspiration System
- K260437 — Valvuloplasty Balloon Catheter (ValvuloPro)
- K260519 — Smart Fit TorsoCardiac 1.5T
- K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more
- K260551 — HemosIL Factor V Leiden (APC Resistance V)
- K260561 — Arthrex FiberTak Suture Anchor
- K260585 — Noxturnal Web
- K252101 — JWG-1
- K253139 — Disposable Distal Cap
- K253432 — DiversiVy Facet Screw System
- K253746 — Enroute 0.014'' Transcarotid Guidewire
- K253965 — CureLight Medical Diode Laser Systems (CureLight F2-A15 +5 more
- K254112 — Dia-X Sil Bite
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K260448 — CastleLoc Pectus Bar System
- K260509 — AutoContour (RADAC V5)
- K260532 — Derma-Gide
- K260533 — ELISIO-H
- K260537 — Willow 24 Guidewire
- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- K252304 — syngo.via RT Image Suite VC10
- K252961 — Fusion FibFix Nail
- K253012 — AlignRT Plus (8.0)
- K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments
- K253622 — Safety Pen Needle
- K253834 — VISUREF 600
- K254110 — DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
- K260188 — LimFlow Vector
- K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
- DEN250014 — Tyto Insights for Eardrum Bulging Detection
- K251926 — enCore Impression Material
- K252078 — BreathePal Bilevel (GFM50-MD2201)
- K252813 — Electrical Scooter (SM4226)
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K253587 — Cala kIQ Plus
- K253614 — EchoNavigator R5.0
- K253750 — BTL-785NEH
- K253863 — GUARDIAN Quick Dip Residual Chlorine (5212)
- K253886 — Grappler Suture Anchor PCFD Tether System
- K254053 — APS Spear Locking Plate
- K254167 — MDx-Chex for BCY
- K260390 — Super Upper Limbs Versalock Plating System
- K260546 — Q Pedicle Instruments
- K260632 — LASER THERMAL THERAPY KIT
- K252122 — DCwire Micro-guidewire
- K252282 — SurgiCount+ System
- K252433 — Sonio Detect (v3)
- K253334 — ZENEX Implant System_Short (R-System)
- K253395 — Stealth AXiS ENT clinical application
- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K253590 — Millipede System
- K253705 — Healgen® Accurate Oral Fluid Drug Test
- K253838 — Lifemotion Disposable Membrane Oxygenator
- K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- K253944 — Data Analysis Facilitation Suite (DAFS)
- K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- K254079 — LED Light Therapy Mask (Models: T2, RLD10)
- K254176 — SINEFIX
- K260511 — Ulike Reglow Light Therapy Device (UM10)
- K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more
- K251848 — Pentacam® Cornea OCT
- K251916 — GenBody COVID-19 Ag Home Test
- K251999 — Promogran Prisma Collagen Matrix with ORC and Silver
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
- K252249 — Extremity CT Imaging System
- K252261 — InferCare RECIST
- K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K252648 — Niti-S SPAXUS Stent
- K252923 — IASIS i2 Relaxation Neurofeedback System
- K253111 — Aeka Imaging
- K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50)
- K253261 — Apollo Quattro (APQ-10M)
- K253391 — Visualase Cooled Laser Applicator System (3 models)
- K253732 — Permatage Flowable, Settable Bone Paste
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
- K254059 — Access anti-HBc IgM
- K254277 — Embrace Neonatal MRI System
- K260078 — Aquilion ServeSP (TSX-307B) V2.0
- K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
- K260455 — New Wave System
- K260479 — TheraSphere 360 Y-90 Management Platform
- K260499 — Amplatzer Trevisio Intravascular Delivery System +1 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.