FDA 510(k) clearances — page 56
clearances on record, most recent first.
Clearances — page 56
5,501–5,600 of 176,479- 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 +1 more
- 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 (4 models)
- 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
- K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- K243702 — V8 Diagnostic Ultrasound System +5 more
- K243907 — Affixus Tibial Nailing System - 4mm screws
- K243961 — Electrically Powered Wheelchair
- K243962 — Electrically Powered Wheelchair
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K241451 — Rusch Endotracheal Tubes (3 models)
- K241462 — LONGY Implant and LONGY-N Implant
- K241634 — Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
- K241817 — InSet Total Shoulder System
- K241897 — MOR
- K243155 — Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)
- K243188 — CYLOX® ST
- K243317 — NUVENTUS NV.C Surgical Cassette and Tray
- K243518 — BinaxNOW COVID-19 Antigen Self Test
- K243620 — Vivid iq
- K243628 — Vivid T9/Vivid T8
- K250200 — InbellaBody System
- K240958 — Locking Plates and Screws Systems
- K241516 — BTL-398
- K241659 — Ultrasound Workspace (UWS 6.0)
- K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
- K243063 — Myolight Microcurrent Handpiece
- K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
- K243453 — Philips Lumea IPL
- K243511 — OTC TENS & EMS Unit
- K243516 — Remi Custom Night Guard
- K244042 — Calcium2
- K241453 — Elecsys sFlt-1 and Elecsys PlGF
- K241483 — ceramys femoral head system
- K242368 — Symani Surgical System
- K242404 — BDC Dental Unit
- K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System
- K242713 — Any-Com Bulk
- K242957 — Identify (4.0)
- K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)
- K243661 — Electronic Blood Pressure Monitor
- K243780 — HELIOS 785 Pico (1754V2)
- K243996 — AssureTech Panel Dip Tests +3 more
- K241599 — Signature Osteosynthesis Plate System
- K241702 — CROSSLEAD 0.014inch
Data sourced from openFDA. This site is unofficial and independent of the FDA.