FDA 510(k) clearances — page 154
clearances on record, most recent first.
Clearances — page 154
15,301–15,400 of 176,479- K213165 — Rapid
- K220047 — AcQCross Qx Integrated Transseptal Dilator/Needle
- K201191 — ELEC-LED
- K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
- K210356 — Noris Medical Dental Implants System
- K211417 — F3D-C2 Cervical Stand-Alone System
- K212271 — smart-sync
- K212419 — Magnifico Open, Magnifico MSK
- K212654 — Micro C Medical Imaging System, M01
- K212721 — Genex Bone Graft Substitute
- K212724 — BD Vacutainer UltraTouch Push Button Blood Collection Set
- K212774 — VenSure LightGuide
- K212849 — VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)
- K213569 — HOLLYWOOD SPECTRA Laser System
- K213777 — Stryker Resorbable Fixation System
- K213801 — Veuron-Brain-pAb2
- K213938 — Revolution Ascend
- K214062 — Radialis PET Camera
- K220020 — Cryo 7
- K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
- K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
- K220098 — Digital Radiography CXDI-Pro, Digital Radiography D1
- K203335 — MectaScrew Extension
- K210826 — Healing Abutment, Cover Screw
- K211822 — LifePath Remote Patient Monitoring Platform
- K212382 — Ambu® aScope Gastro, Ambu® aBox2
- K213824 — Sonopet iQ Ultrasonic Aspirator System
- K213976 — Contour ProtégéAI
- K220071 — Soniquence Reusable Neutral Plate
- K201403 — NATtrol BD MAX Vaginal Panel External Controls
- K203586 — EndoSerter-PL
- K210832 — EVOCLEAN CLEANsert Ultrasonic Insert
- K211228 — Rosso
- K211603 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
- K212079 — TeesuVac Breast Biopsy Device Mark 1
- K213554 — Sentient Manufacturing Laser Fiber
- K213812 — PALACOS MV pro
- K213814 — Viveve 2.0 System
- K203088 — Infinity Acute Care System (IACS) Monitoring System
- K210727 — HotDog Warming Mattress + Return Electrode
- K211701 — X-Guide® Surgical Navigation System
- K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
- K212611 — CO2 Laser Equipment
- K213565 — JETi AIO Peripheral Thrombectomy System
- K213701 — Exeter® X3® RimFit® Cup
- K213830 — Home use hair removal device, model: Precise Touch Pro
- K220257 — Permadyne
- K203272 — Alltest Pregnancy Rapid Combo Test Cassette
- K211628 — MIS Precision Chevron Bunion System
- K213188 — Primary Relief
- K213401 — DIAPLUS Universal
- K213908 — SKR 3000
- K220023 — 8mm Monopolar Curved Scissors
- K203260 — syngo.CT Brain Hemorrhage
- K203395 — Platform treatment system
- K211096 — Optiflow Oxygen Kit
- K212120 — Surgical Masks
- K212341 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
- K212533 — BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
- K212598 — iHealth infrared Ear thermometer PT5
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K212943 — SyntheCel Dura Repair
- K213082 — Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
- K213093 — STEP-1 PumEtch
- K213142 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
- K213317 — ShinEvac Smoke Evacuation Pencil
- K213325 — Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
- K213523 — X-CUBE i8, X-CUBE i9
- K214106 — QuikPass Catheter
- K203768 — Omnipod 5 ACE Pump (Pod)
- K203772 — Omnipod 5 SmartBolus Calculator
- K203774 — SmartAdjust technology
- K210360 — Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
- K211210 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K211436 — Intermittent Catheter (Not Finalized)
- K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- K211941 — 9Line
- K212312 — RA-T59 Wrist blood pressure monitor
- K212373 — Sim&Size
- K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
- K213475 — Elevo Snoring Intervention Set
- K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
- K213493 — Fortilink with TiPlus Technology
- K213771 — Merlin Aspiration System
- K202914 — SternaFuse Fixation System
- K210101 — American-Made Surgical Mask
- K211219 — LASSOSTAR NAV Circular Mapping Catheter
- K212610 — Surgical Face Mask
- K212771 — LightStim Elipsa
- K212868 — JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
- K212938 — Vitalograph Model 6000 Alpha
- K213591 — ANTHEM® Fracture System
- K213692 — SmoothSkin Pure Mini
- K201323 — INNO SLA Submerged Implant System
- K211355 — iCare HOME2
- K212173 — HDH Treatment Planning System
- K213347 — ADI Medical Surgical Face Mask
- K211482 — Disposable Syringe with Needle
- K212333 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
- K213639 — Revaclear 500, Revaclear 400, Revaclear 300
Data sourced from openFDA. This site is unofficial and independent of the FDA.