FDA 510(k) clearances — page 47
clearances on record, most recent first.
Clearances — page 47
4,601–4,700 of 176,479- K251383 — Prestige Coil System (Prestige Packing Line Extension)
- K251406 — BriefCase-Triage
- DEN240048 — Spur Peripheral Retrievable Stent System
- K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
- K243372 — BiliWrap
- K243469 — SIGNEX
- K243480 — SuturePatch Tissue Reinforcement
- K243484 — PM2+ System and SmartPICC Stylet
- K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
- K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
- K250048 — NEUROMARK System (NMK00301)
- K250215 — Baha 7 Sound Processor +4 more
- K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)
- K250543 — Voluson Performance 16; Voluson Performance 18
- K250606 — Dental Barrier and Sleeves
- K250673 — CERABIEN MiLai
- K250757 — Radius VSM and Accessories
- K251315 — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
- K251325 — VersaCross Connect Transseptal Dilator
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
- K240950 — Disposable Prophy Angle
- K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US) +2 more
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
- K242793 — Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0 +3 more
- K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
- K243378 — Rapid MLS
- K243716 — Zionic Pro Max (Radiofrequency)
- K243949 — OsteoFlo HydroFiber
- K244049 — Europa (Alternative: AiRTouch) portable X-ray system
- K250367 — CoLumboX
- K250427 — TAIMedImg DeepMets
- K250624 — myAir
- K251344 — OptiMap System
- K242604 — Helios+ UV-C System
- K242611 — Integral Dental Units
- K242820 — Puritan PurSafe Plus Collection and Transport System
- K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- K243777 — Rennou Varnish (4 models)
- K250435 — Dexter L6 System
- K250475 — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
- K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- K250614 — Neodent Implant System - Custom Abutments
- K250932 — DeepRhythmAI
- K251309 — OSSIOfiber® Suture Anchor
- K251578 — BEAUTIFIL II
- K242545 — RadiForce MX317W-PA
- K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S
- K242594 — DEEPECHO
- K243023 — WiZARD 520 Full Face Mask
- K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- K243474 — MagnetOs MIS
- K243937 — Accuro 3S
- K243989 — Second Opinion® 3D
- K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
- K250005 — Clever One
- K250239 — NeuroMatch
- K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
- K250384 — IPL400
- K250446 — Frida Anterior Cervical Plate System
- K250544 — Knotilus+ Biocomposite Knotless Anchor
- K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- K250778 — Sil-Flow
- K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK +1 more
- K251044 — 93 NeuFlex Catheter
- K251211 — ViewFlex Xtra ICE Catheter +5 more
- K251292 — RECLAIM Monobloc Revision Femoral Stem
- DEN240035 — ConcizuTrace ELISA
- K242586 — ArgoCap (200.52)
- K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
- K242684 — Harioculture TL-16 Time-lapse Incubator
- K250532 — Solawave 2-in-1 Skincare Mini (Model: 61043)
- K250630 — Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- K250639 — DESS Dental Smart Solutions
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E)
- K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter
- K250920 — Arthrex Spine Compression FT Screw
- K250935 — TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
- K250980 — Physica System (Physica CR Porous Femoral components)
- K251052 — Trivicta® Hip Stem
- K251493 — Skin Clinic Freeze Point for Warts and Skin Tags
- K242527 — The Karma® Fixation System
- K242637 — MEM Clear Aligner System
- K242857 — ClearHemograsper
- K243116 — FlareHawk Interbody Fusion System
- K243122 — uMR Omega
- K243302 — 3DMatrix DynaFlex (DynaFlex)
- K243429 — HJY VisualNext 3D Endoscopic Vision System
- K243762 — Synapse 3D Base Tools (V7.0)
- K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K243866 — InVision Precision Cardiac Amyloid
- K250493 — MotiliCap GI Monitoring System
- K250528 — Stryker AlphaVent Knotless SP Biocomposite Anchor
- K250798 — Control-IQ+ technology
- K251109 — SMARTDent
- K251230 — The Alma Hybrid Laser System
- K251239 — GrandioSO Unlimited
- K251276 — Swoop® Portable MR Imaging® System
- K242485 — EveryWare
- K250199 — VitalFlow Console
Data sourced from openFDA. This site is unofficial and independent of the FDA.