FDA 510(k) clearances — page 13
clearances on record, most recent first.
Clearances — page 13
1,201–1,300 of 176,428- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K260289 — Perfect-O Ostial Positioning Catheter
- K260301 — Vial Adapter
- K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
- K260761 — APTUS Clavicle System 2.8
- K261492 — FieldFlex Steerable Sheath
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K253004 — LUNA 3D
- K253020 — Strauss Surgical Resection Instruments
- K253026 — Respiratory Gating for Scanners (2.1)
- K253102 — GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
- K253553 — Orion
- K253602 — Precision S 4K Sinuscope
- K253893 — Harmony Referral System with Harmony OCT Viewer (Octave)
- K253984 — Instrument Exit Point on Touch Surgery Aide
- K253994 — TroKit Laparoscope Lens Wiper
- K254209 — Radius VSM and Accessories
- K260497 — DEEPVESSEL Plaque
- K260662 — Dental Cone Beam Computed Tomography System
- K260690 — LumiGlam Laser System (SHE-LSP601-3)
- K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- K260956 — Spectra Platinum Mini
- K261510 — Signature ONE System
- K261519 — Sonio Suspect
- K252800 — KARL STORZ Endoscopic Accessories for Urology
- K252854 — SteriTite Container System with MediTray Products
- K252904 — SIC Abutments including CAD/CAM Solutions
- K253124 — Upper arm electronic blood pressure monitor (XB-01)
- K253600 — Scooter (YD-03)
- K253974 — Roosin Collagen Dressing
- K254034 — Roosin Collagen Powder
- K260116 — CustoMED Viewer
- K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
- K260373 — Electric Wheelchair (DF506)
- K260402 — MeRT System
- K260703 — Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl +1 more
- K260715 — CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
- K260726 — Straumann® ProClean Cassette (041.800; 041.801)
- K260780 — HeartFocus
- K260806 — Nitrile Disposable Examination Gloves
- K261439 — Permatage Flowable, Settable Hemostatic Bone Paste
- K261484 — Tissue Approximation System
- K261522 — BioWave BioWraps
- K261530 — iiSure Infusion Set
- K261826 — VSP System (Titanium Palatal Splint)
- K261840 — BracePaste Prime Plus
- K252532 — Inno-Port Disposable Bladed Trocar
- K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)
- K252844 — Tyto Insights for Wheeze Detection (with PCCP)
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
- K253302 — Hemospray Endoscopic Hemostat (HEMO-[X])
- K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
- K253803 — MILAN System
- K253918 — Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
- K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
- K260364 — Device 300419 Strip
- K260569 — DB 4000 High Impact Denture Base
- K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- K260642 — Manual Wheelchair (LW01108)
- K261002 — Pectus Blu System
- K261093 — DIAFIL
- K261540 — Cube 4D Navigation System, VirtuEye Pro
- K253882 — CorDx Tyfast COVID-19 Ag Rapid Test Rx
- K260456 — VI°Port Liver Preservation System
- K261541 — VisionAir Enhanced Stock Stent
- K261154 — CoLink® & CoLag® Non-Sterile Screws
- K252396 — Cryo Sport 2.0 (AVA 501)
- K252802 — Peak Flow Meter (PF-10(BR-PEF231))
- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252840 — M12 Telemetry System
- K252859 — ZEUS Platform (FG0501US)
- K252947 — HistoSonics® Planning Tool
- K252965 — Oxygen Concentrator (OX-5A, OX-5C)
- K253103 — Nexus DRF Digital X-ray Imaging System
- K253119 — CoSense ETCO Monitor
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
- K260077 — OrthoGrid Hip AI® 4.0
- K260138 — LUNE PureHygiene
- K260262 — Injection Needle
- K260489 — LASEmaR 1500
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K261038 — Xpert PFP
- K261060 — Navigated LLIF Impactable Tracker
- K261159 — Exceed® Biplanar Expandable Interbody System
- K261202 — ENTire IRE System
- K261369 — GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US)
- K251840 — Zimmer® Persona® Personalized Knee System
- K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
- K252712 — STIMPOD NMS460 Nerve Stimulator
- K252823 — Dukal Crepe Paper Sterilization Wrap
- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K253894 — BMD Titanium Spinal Fusion System
- K253931 — Arthrex Bioabsorbable PushLock Suture Anchors
- K254092 — Bellalun 2D (VDMS-1000S)
- K260213 — BD BACTEC FXI Culture System
- K260295 — Helio Kids; Apex P
- K260423 — Disposable Endoscopic Distal Attachments
- K260895 — Ulike Clear Zero (YC10 BU)
Data sourced from openFDA. This site is unofficial and independent of the FDA.