FDA 510(k) clearances — page 12
clearances on record, most recent first.
Clearances — page 12
1,101–1,200 of 175,620- K260697 — VyPlate Anterior Cervical Plate System
- K260746 — S-scan Open (100001800)
- K252926 — Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
- K253379 — Stealth AXiS Cranial clinical application
- K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555)
- K253627 — Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
- K253775 — SwiftMR
- K253796 — Lunit INSIGHT DBT (V1.2)
- K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
- K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- K260601 — REAL INTELLIGENCE CORI
- K260626 — Multiflex Steerable Sheath 17.5F
- K252023 — MiraChlor Antimicrobial Wound Solution
- K252037 — CUVIS-joint (CJ150)
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K252432 — Flex-Z Cervical Cage
- K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- K253615 — Invictus Bands System
- K253680 — LYNX COBLATION Laryngeal Wand (72290254)
- K254278 — Arterial Pressure Monitoring Set/Tray
- K260274 — Airlock® Ankle Plating System
- K260291 — Vortex5 Tailor's Bunion Correction System
- K252099 — Trinias
- K252169 — Access BNP II
- K252421 — JLK-NCCT
- K253047 — PRESSONE
- K253198 — NanoKnife Generator (H78720300351US0)
- K254012 — Electric Wheelchair (E201)
- K254253 — LOQTEQ® VA Proximal Humerus Plate 3.5
- K260087 — Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
- K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
- K260787 — FebriDx Bacterial/Non-bacterial Assay
- K252031 — Adin Long Dental Implant System
- K252992 — CT Rembra RT; CT Areta RT; CT Rembra
- K253686 — True Definition DL
- K254166 — MDx-Chex for BCN
- K254275 — HyperSuture All Green Extension Line
- K254288 — Clavicle Fixation System
- K260112 — QuikFix External Fixator: Knee-Spanning Pack
- K260202 — LED Light Therapy Masks (LumiLips FAC07NA)
- K251937 — nordicAudio (1.0)
- K251950 — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)
- 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; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
- 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; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
- K254112 — Dia-X Sil Bite
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
- 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; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.