FDA 510(k) clearances — page 47
clearances on record, most recent first.
Clearances — page 47
4,601–4,700 of 175,620- K250348 — JLK-AILink
- K241565 — Sterilization Package/Reel
- K241703 — SD Implant System
- K242994 — OncoStudio (OS-01)
- K243035 — Ulthera® System
- K243287 — APRO 70 Swift Catheter and Alembic Aspiration Tubing
- K243823 — Control-IQ+ technology
- K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- K244010 — ExamVue Apex
- K241186 — Synthetic Bone Graft Particulate
- K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
- K241563 — Extremity Medical External Fixation System
- K241983 — Fassier-Duval Telescoping IM System
- K242607 — ScanDiags Ortho L-Spine MR-Q
- K242838 — QuickRad
- K242850 — Wearable breast pump (model W8)
- K242898 — Sterilization Pouches and Reels
- K243088 — Green X 12 SE (PHT-40CHS)
- K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
- K243258 — Paradigm System
- K243278 — Custom Abutments
- K243330 — LYMA Laser PRO
- K243431 — Medicom Sterilization Pouch and Reel
- K243614 — Sonio Suspect
- K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
- K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
- K243916 — Primus Spinal Fixation System
- K243940 — VITA YZ Multi Translucent
- K243951 — TEMP MASTER, PMMA-based dental resin
- K250027 — Powered Mobility Scooter
- K250218 — Xpert® FII & FV
- K234004 — Medical diode laser systems (CHARISMA, REGAL)
- K241470 — CORE Shoulder System
- K241626 — SperSort Sperm Sorting Chip (IPG02)
- K242240 — CaRi-Plaque
- K242447 — Falcon HST
- K242681 — NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
- K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
- K243086 — Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
- K243283 — Alinity h-series System
- K243312 — CER-S
- K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
- K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter
- K250172 — Green Card Bowie-Dick Test (BD115)
- K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
- K250487 — SparkTM Clear Aligner System
- K241578 — Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
- K241666 — EVOS Pelvic and Acetabular System
- K242023 — Microdent Sterilization Cassette
- K242411 — Brainomix 360 e-Lung
- K242455 — AViTA Pulse Oximeter (SP62B)
- K242526 — Visby Medical Respiratory Health Test
- K243206 — Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
- K243241 — Phasix ST Umbilical Hernia Patch
- K243478 — Straumann InLab Validated Workflow
- K243588 — Single Use CO2 Laser Fiber (HAF005001)
- K243591 — OPTOVISION Endoscopic Light Source Unit
- K243761 — A.L.P.S. Small Fragment Plating System
- K244015 — SuperBall-RC
- K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
- K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
- K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
- K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom
- K243593 — AXS Lift Intracranial Base Catheter
- K243792 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
- K243915 — FIX-C 3D Ti ACIF System
- K241737 — Sway System Sports Plus
- K241527 — Pastelle Pro
- K241573 — Alinity m Resp-4-Plex
- K241643 — WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
- K241958 — WARD-CSS (v1.2.x)
- K242198 — ICS Dizcovery (1091)
- K242593 — CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
- K242776 — LimFlow V-Ceiver
- K243081 — Green X 21 (PHT-90CHO)
- K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
- K243212 — DESS Dental Smart Solutions
- K243294 — Brainomix 360 e-ASPECTS
- K243503 — VIA360 Surgical System
- K243696 — AVIEW CAC
- K250248 — BriefCase-Triage
- K241410 — EDEN ControlCath
- K241597 — Freedom® Total Knee System - Porous Tibial Base Plate
- K241832 — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
- K242317 — Integrated Endo System (Meet Endo-II)
- K243319 — Ampa One System (AMPA-001)
- K243396 — Aptima SARS-CoV-2 Assay
- K243546 — AH Plus Endodontic Sealer
- K243778 — Body Temperature Software (BTS)
- K243912 — Newclip Patient-matched instrumentation non sterile PSI
- K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
- K241418 — OptoMonitor 3
- K241425 — AspenView
- K241479 — Etiometry Platform (DAV 5.4 RAE 9.2)
- K242006 — SureWave Elastography (Q7000225)
- K242666 — Fecobionics Anorectal System
- K243250 — SubtleHD (1.x)
- K243523 — NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Data sourced from openFDA. This site is unofficial and independent of the FDA.