FDA 510(k) clearances — page 72
clearances on record, most recent first.
Clearances — page 72
7,101–7,200 of 175,620- K232475 — Disposable infusion set with needle
- K232507 — Aerogen®Solo Nebulizer System
- K233100 — QIAstat-Dx® Respiratory Panel Plus
- K233277 — Filter Needle for Single Use
- K233629 — APERTO Lucent MRI System
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer
- K234079 — HyperSuture Extension Line
- K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- K240365 — Bioceramic Root Repair Material (C-Root BP)
- K240374 — Ureterorenoscope System
- K240479 — Access OV Monitor
- K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
- K240699 — SCARLET® AC-Ti
- K240708 — Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
- K232025 — Hushd Pro Avera
- K232468 — SC Medica FFX
- K232470 — Polyisoprene Extra Large Condom
- K232477 — Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
- K232976 — VUZE System
- K233418 — Biofourmis Everion+ (G2)
- K233602 — P200TE (A10700)
- K233918 — Dental Barrier and Sleeves
- K233967 — DePuy Synthes MatrixSTERNUM Fixation System
- K233982 — CEREGLIDE 92 Catheter System
- K234112 — Customized Abutment
- K240296 — Tulsa Pro System (Pad-105)
- K240403 — Access BR Monitor
- K240495 — Flexible Fixation Device for Gynecological Applicators (GM11001960)
- K222292 — F&P myAirvo 3
- K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K233803 — UltraClear Laser System (N/A)
- K240964 — FLOW 90? Wand
- K240999 — Legend X Applicator VO
- K241008 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)
- K231612 — Eve Patient Positioner System
- K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable
- K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K232833 — HALO AP Dx
- K232928 — DeepContour (V1.0)
- K233695 — Medical HAL Lower Limb Type (HAL-ML)
- K233766 — Geneo X Elite
- K233864 — ASSURE Wearable ECG
- K234018 — CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System
- K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
- K240377 — LIFEPAK® ECG Cables
- K240954 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K232514 — MIM Dose Analysis
- K233800 — Vertos mild Device Kit (MDK-0002)
- K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
- K240007 — Solar Compact (G4-1)
- K240392 — JAZZ Spinal System
- K240685 — Salvo® Spine System
- K232416 — AUTION EYE AI-4510 Urine Particle Analysis System
- K232454 — Viral Transport Media (VTM)
- K232491 — CT 5300
- K232648 — RODEO Telescopic Nail
- K232733 — Mbrace Cable
- K232735 — EMA 3D
- K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer
- K232895 — B-Ultrasound Diagnostic System
- K232941 — Megaloop Button System
- K233157 — VaporMAX LDD; MOJo LDD; MegaJOULE LDD
- K233349 — Alinity m HSV 1 & 2 / VZV
- K233524 — Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
- K233687 — ECHELON Synergy V10.0
- K234021 — Masimo Stork
- K234088 — Emily's Care Nourish Test System (Model 1)
- K240126 — ProAM ALIF System
- K240185 — Cypris eXact Suture Placement Device
- K240297 — Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS)
- K240625 — CORUS Navigation Access System
- K240800 — Access Intrinsic Factor Ab
- K240919 — Silk Voice (SMI-04)
- K240940 — Vial2Bag Advanced® 20mm Admixture Device
- K232445 — CSF-4 (CSF-4)
- K232464 — VereSee Optical Veres Needle System
- K232902 — EVA15 insufflator
- K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
- K233689 — Hope&Her Vaginal Dilators
- K233752 — Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
- K233857 — Neodent Implant System Custom Abutments
- K240012 — Mobility Scooter (W3431)
- K240037 — Revi System
- K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
- K240636 — HemoScreen Hematology Analyzer
- K231722 — SmarTooth
- K232370 — Percutaneous Nephroscope System
- K232858 — ORskin Blue
- K233203 — Soft Tissue Augmentation Resorbable Matrix
- K233284 — Vial Adapter with Filter
- K233513 — Remex Spine Surgery Navigation System II
- K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
- K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
- K240279 — VIDAS TBI (GFAP, UCH-L1)
- K240829 — AuST Steerable Sheath
- K240882 — BruxZir® Esthetic
- K240900 — HOTWIRE RF Guidewire
- K240925 — DuraGraft Vascular Conduit Solution
Data sourced from openFDA. This site is unofficial and independent of the FDA.