FDA 510(k) clearances — page 36
clearances on record, most recent first.
Clearances — page 36
3,501–3,600 of 176,479- K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K250318 — Planmed XFI
- K250659 — LoFric Origo
- K251204 — FUJIFILM Stiffening Wire Device (SW-2000)
- K251208 — Tuned Self-Fitting Mobile App
- K251262 — S.I.N. Dental Implant System
- K251275 — VitalStream ART Connect; VitalStream-Hemo
- K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
- K251919 — Thulium Laser System (Deluxlase)
- K251986 — AUXILIARY WATER TUBE MAJ-855
- K252105 — Ligence Heart
- K252221 — Inset Reverse Total Shoulder System
- K252435 — Magnetic Surgical System
- K252700 — Optima Coil System (Optima Packing Coil System)
- K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps
- DEN250016 — Essilor® Stellest®
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear) +1 more
- K250076 — Endeavor Stand-Alone Cervical IBF System
- K250837 — Pulse Oximeter
- K251148 — JDEvolution Plus L and JDEvolution Plus LE
- K251465 — Root canal repair materials (nRoot BP)
- K251512 — Hi bebe super (BT-150B)
- K251527 — Brain WMH
- K251789 — EMBOTRAP III Revascularization Device
- K251791 — Auxano® Wedge Fixation System
- K251812 — Steripath® Flow Blood Collection System
- K251868 — Panther Fusion GI Bacterial Assay
- K251971 — RPS Primary TKA Software +6 more
- K251993 — Panther Fusion GI Expanded Bacterial Assay
- K251997 — Single-Use Biopsy Valve (MAJ-1555)
- K252013 — EnSite X EP System
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K252063 — Medical Diode Laser Systems (4 models)
- K252102 — Alinity m HCV
- K252371 — uMR 680
- K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)
- K243910 — Retraxil
- K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- K250045 — uWS-Angio Pro
- K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
- K250792 — t:slim X2 insulin pump with interoperable technology
- K251206 — Digital X-Ray DentiMax Pro Imaging System
- K251734 — ProVee Video Processing Unit (PV-003)
- K252183 — Resitu Slider 09 (RESL09)
- K252227 — Pounce(TM) Sheath
- K252680 — Celerity 20 HP Biological Indicator
- K252682 — LenSx Laser System (8065000944)
- K252689 — MEDRAD Centargo CT Injection System +4 more
- K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000) +1 more
- DEN240080 — Biolinq Shine Autonomous Time-in-Range Microsensor
- K250209 — Polyvinyl Alcohol Embolic Microspheres
- K251140 — Zenflow Spring Scope
- K251483 — SwiftSight-Brain
- K251894 — Himaging Bronchscope System
- K251973 — Luminance Red Cold Sore Device (TN1927G)
- K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)
- K251987 — Rapid Aortic Measurements
- K252043 — Bipolar applicator CelonProBreath (WB990310) +3 more
- K252045 — Ion Endoluminal System (IF1000)
- K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
- K243645 — IC-Flow Imaging System 2.0
- K250205 — Babio® Virus Transport Kit (Non-inactivating)
- K250388 — ENDOFLATOR +
- K251743 — SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
- K252315 — Santreva-ATK Endovascular Revasculariztion Catheter
- DEN240067 — KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
- K241868 — xR IVD
- K242859 — VEGA
- K243920 — Purema H Hemoconcentrator - Pediatric
- K243990 — BondEase 2 Topical Skin Adhesive
- K244035 — Portable mesh nebulizer (JM821)
- K250128 — Single Use Suction-Evacuation Ureteral Access Sheath
- K250408 — Alegria Flash ENA Screen
- K250450 — Coated hip implants
- K250649 — Bunkerhill ECG-EF
- K250777 — Sonicaid Team3
- K250953 — EQUIA LC ONE
- K251002 — Videa Dental AI
- K251100 — IPGTFL-02
- K251167 — uDR Aurora CX
- K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more
- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K252285 — Well-Root PT
- K252613 — Unscented menstrual three-piece applicator tampon
- K252647 — Tapestry Biointegrative Implant
- K252657 — Impact PEEK Union Nail System
- K252662 — UniBur
- K250369 — Axial3D Insight
- K250883 — ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
- K251377 — Magic InBra
- K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)) +3 more
- K251597 — InnerView System
- K251649 — Sunny Plus (Sunny)
- K251905 — Normatec Elite Hip
- K252428 — Electric Wheelchair (Model P2)
- K243752 — Double Tube Herbst Appliance
- K244006 — FG Bone Graft M
- K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
Data sourced from openFDA. This site is unofficial and independent of the FDA.