FDA 510(k) clearances — page 36
clearances on record, most recent first.
Clearances — page 36
3,501–3,600 of 175,620- K251570 — Hippocampe Marathon and Trail
- K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
- K242911 — Medconn Glycated Hemoglobin Test system
- K242964 — Celsi Warmer
- K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
- K242981 — Atellica IM Thyroglobulin (Tg)
- K242985 — CollOvine Wound Dressing
- K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- K243053 — Navient Image Guided Navigation System (ENT) (955-NC-NC)
- K243062 — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
- K243120 — HybridAPC probe
- K243168 — Alinity i Rubella IgG
- K243398 — CT Scanner TSX-501R/1 V11.1
- K243589 — PAL Sterilization Case
- K243978 — LED Facial Mask
- K250037 — Incompass Total Ankle System
- K250151 — Us2.ca
- K250566 — EsCem RMGI
- K250583 — AdheResp Smart Breath-actuated Mesh Nebulizer
- K250732 — Disposable Endoscopy Valve Set
- K250877 — TMINI Miniature Robotic System
- K250880 — LED LIGHT MASK (A093)
- K250968 — PathPresenter Clinical Viewer
- K251114 — FloPatch FP120
- K251224 — Restrata Soft Tissue Reinforcement (STR)
- K251240 — Branchor X Balloon Guide Catheter
- K251248 — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
- K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
- K251560 — FUBUKI XF-R Neurovascular Long Sheath
- K251567 — NovoSorb BTM
- K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device)
- K250515 — EpiMonitor
- K251235 — Electrosurgical Pads
- K242224 — Happy Health Home Sleep Test
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
- K242917 — Enteral Drainage System, Enteral Medicine straw
- K242922 — Extracorporeal Shock Wave Lithotripter (U200)
- K242933 — SPINEART Navigation Instrument System
- K243014 — EyeQ nanoECP
- K243039 — Ureteral Stents (AF-D series)
- K243102 — Mobility Scooter (JT10)
- K243172 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
- K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
- K243366 — DRX9000C-SL Cervical Spinal Decompression System
- K243583 — F&P Nova Nasal Mask
- K243672 — CardIQ Suite
- K250082 — Procedure mask/Surgical mask/Face mask
- K250492 — FlexiGo 3D Delivery Catheter
- K250845 — Curiteva Porous PEEK Standalone ALIF System
- K250872 — Bioline Dental Implant System
- K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K250908 — Virata Spinal Fixation System
- K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port
- K251296 — The Acumed Wrist Fixation System
- K251530 — CONMED Argo Knotless® Anchor
- K251634 — LZI Fentanyl III Enzyme Immunoassay
- DEN240038 — Oxiplex®
- DEN240066 — COAPTIUM Connect with TISSIUM LIGHT
- K243003 — VitalSigns 1-Lead Holter (VSH101)
- K243133 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
- K243561 — Nano-Check Influenza+COVID-19 Dual Test
- K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
- K243666 — uOmniscan
- K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
- K250219 — Dorado PTA Balloon Dilatation Catheter
- K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
- K250665 — SKR 3000
- K250997 — Integrity Implant
- K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
- K242870 — Access hsTnI
- K242978 — Geo Abutment
- K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)
- K243872 — BD Veritor System for SARS-CoV-2
- K244012 — Mosaic (V1.0.1)
- K250436 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
- K250443 — MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- K250685 — Methinks NCCT Stroke
- K250900 — EvoEndo Single-Use Endoscopy System
- K251617 — X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
- K240795 — Withings ECG App
- K242863 — Bioptimal Bipolar Pacing Catheter
- K243036 — IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
- K242852 — ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
- K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
- K243633 — Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
- K243638 — MV Flow Aspiration Pump (MVFLOWPMP01)
- K243729 — Prismira
- K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
- K250075 — Medtronic Stedi Extra Support Guidewire
- K250251 — Eleganz Fusion Screw System (Fusion Screw System)
- K250273 — BinaxNOW COVID-19 Ag Card
- K250469 — Accuro® 3S Needle Guide Kit
- K250674 — Vessel Sealer Curved (480522)
- K250759 — 3 in 1 TENS UNIT
- K251166 — Mfinity Femoral System
- K251189 — Aventus Thrombectomy System
- K251485 — Excipio LV Prime Thrombectomy Device
- DEN240032 — APO-Easy Genotyping kit
- K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
- K242872 — iDart Lyme IgM ImmunoBlot Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.