FDA 510(k) clearances — page 202
clearances on record, most recent first.
Clearances — page 202
20,101–20,200 of 175,699- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
- K191788 — CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
- K191909 — HepaShield Bacterial Viral Breathing System Filter
- K193453 — TruDi Probe
- K193479 — Sternal Cable System
- K200043 — Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
- K200436 — Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
- K200485 — RadiForce RX1270, RadiForce RX1270-AR
- K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
- K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- K191612 — Encision AEM Monopolar Laparoscopic Instruments and Accessories
- K191657 — Bioland Blood Glucose Monitoring System
- K191680 — AZUR Vascular Plug
- K191735 — CPT Hip System
- K191838 — Clearform Aligners
- K192300 — EnlightenVue Microendoscopy System
- K192510 — DIAFIL & DIAFIL Capsule
- K192897 — icotec Cervical Cage
- K193089 — MULTIX Impact
- K193121 — GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- K193211 — Nano FortiFix® System
- K193281 — Hepatic VCAR
- K193327 — Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
- K193366 — T2 ICF
- K193560 — Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
- K193581 — Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
- K193609 — Q Switched Nd: YAG Laser machine
- K193659 — iTero Element 5D
- K200036 — AI-ECG Tracker
- K200180 — MTS Omadacycline 0.002 - 32 ug/mL
- K200474 — Symbia 6.7
- K191057 — Park's Pectus System
- K191658 — IV Sets not made with PVC
- K191818 — F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
- K191856 — Compression Therapy Device
- K192905 — Creo Electrosurgical System with HS1 Hemostasis Accessory
- K193059 — G1 40 Radiopaque Bone Cement
- K193061 — G3 40 Radiopaque Bone Cement
- K193491 — restor3d Metallic Interference Screw
- K193530 — Deklene MAXX
- K200379 — Super Sheath
- K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- K191876 — PulmoScan
- K193517 — ViziShot 2 FLEX
- K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel
- K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
- K193558 — HEALICOIL Knotless Suture Anchors
- K193658 — Viz ICH
- K200094 — speX LP Support Catheter
- K200113 — LINK TrabecuLink Tibial Cones
- K200198 — WIRION
- K200406 — Evolve Breast Pump
- K200418 — VIVIX-S VW
- K191753 — Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
- K192007 — TheraBase, TheraBase Ca
- K192272 — Wolf445nm
- K192753 — NeuralScan System
- K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
- K193582 — SterilContainer S2 System
- K200136 — Shear Wave Quantificational Ultrasound Diagnostic System
- K200151 — Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
- K200243 — ACUVUE (senofilcon A) Soft Contact Lens Multifocal
- K200433 — iBalance UKA Tibial Tray Implant
- K200443 — EndoTool IV 1.10
- K190495 — Transferrin
- K190767 — AnatomicAligner
- K191705 — OptikView GUP2103CMI
- K191827 — Sunmed Disposable Angio-Closure Pads
- K192713 — Altera Filter and HME/Filter
- K193267 — Al-Rad Companion (Musculoskeletal)
- K193486 — Epic 980
- K200097 — Response BandLoc Spinal Fixation
- K200110 — SANDRO Dual
- K200385 — CONTINUUM PACS
- K200522 — AERO CHROME* Breathable Performance Surgical Gowns
- K190783 — Health Expert Electronic Stimulator (model: AST-300L)
- K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
- K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
- K192241 — Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K192483 — MeDioStar
- K192720 — GIA Stapler with Tri-Staple Technology
- K192817 — Curian HpSA, Curian Analyzer
- K192888 — EzOrtho
- K192925 — 32HL512D
- K193105 — iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
- K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K193244 — Indigo Aspiration System Lightning Aspiration Tubing
- K193325 — Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
- K193418 — SeaSpine Skipjack System
- K193482 — PrisMax System Version 3
- K193572 — VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
- K200069 — Disposable SpO2 Sensor
- K200075 — 3DMetal Diaphyseal Femoral Cones
- K200183 — CS 9600
- K200349 — Stat Profile Prime Plus Analyzer System
- K200358 — Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
- K200407 — LEGION Inserts with JRNY Lock
- K190978 — RefleXion Medical Radiotherapy System
- K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
Data sourced from openFDA. This site is unofficial and independent of the FDA.