FDA 510(k) clearances — page 45
clearances on record, most recent first.
Clearances — page 45
4,401–4,500 of 176,479- K243172 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs +1 more
- 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 +3 more
- 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) +11 more
- 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) +3 more
- K243633 — Brainlab Elements (7.0) +5 more
- 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
- K243234 — Second Opinion® CS
- K243608 — TRIGEN Stable Lock Nut & Washer
- K243683 — Deka Bluebeam
- K243973 — FIX-L PEEK PLIF and T-PLIF System
- K250559 — GMReis Fibula Nail System
- K250782 — Fractional CO2 Laser Machine
- K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
- K250826 — Multi M Series
- K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
- K250936 — Q-Switched Nd:YAG Laser (SHE-LSP101-1)
- K251153 — Aurora
- K251154 — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
- K251193 — Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
- K251209 — Medical Monitor (32HS710S)
- K251279 — Disposable Cytology Brush BC-202D/203D Series
- K251459 — OneLIF Interbody Fusion System
- K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped
- K240852 — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- K243482 — Self-Forming Magnet (Flexagon)
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K250584 — Rezum System
- K250646 — Impact PEEK Union Nail System
- K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP)
- K250787 — Liberant Thrombectomy System
- K250933 — LORRAINE 2.5/3.5mm Distal Humerus System
- K251499 — Frova Intubating Introducer (4 models)
- K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm +3 more
- K242996 — EndyMed PRO MAX
- K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K250010 — EXTRON 3; EXTRON 5; EXTRON 7
- K250354 — Viz Subdural+, Viz SUBDURAL PLUS
- K250735 — Dental Barrier and Sleeves
- K250768 — Elecsys Anti-SARS-CoV-2
- K250465 — CO2 Laser Machine (Lume)
- K250830 — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
- K251093 — Bonvadis®
- K251500 — MallyaG Injection Pen Adapter (MallyaG)
- K250746 — Magnetic Surgical System
- K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Data sourced from openFDA. This site is unofficial and independent of the FDA.