FDA 510(k) clearances — page 42
clearances on record, most recent first.
Clearances — page 42
4,101–4,200 of 176,479- K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2)
- K250750 — INNOVISION-P5
- K250902 — HeartFlow Analysis
- K250952 — Baby Gorilla®/Gorilla® Plating System
- K250999 — V8 Diagnostic Ultrasound System +9 more
- K251542 — InstaFAN
- K251585 — Profoject Enteral Feeding Syringe
- K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
- K251809 — Arthrex FiberTak Suture Anchor
- K251906 — Z1 Hip System
- K252012 — SPY Cystoscope/Hysteroscope
- K252218 — MF SC GEN2 Facial Toning System
- K242505 — Elecsys Cortisol III
- K243324 — Masimo O3 Regional Oximeter
- K243420 — HESTIA
- K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
- K243547 — uMR Ultra
- K243756 — 0.014 Willow Guidewire
- K250751 — DualView Catheter
- K251016 — MectaLIF 3D Metal
- K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
- K251491 — K5 Cart, K5 Mount, K5 Swing
- K251556 — Device 300423 Granules
- K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- K243397 — uMR 680
- K243412 — ARCHIMEDES Biodegradable Pancreatic Stent
- K243782 — StimTrial Neuromodulation System
- K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
- K251102 — Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)
- K251151 — Rapid CTA 360
- K251198 — HyperVue Software
- K251202 — da Vinci Surgical System (IS5000)
- K251342 — EchoPAC Software Only / EchoPAC Plug-in
- K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
- K242237 — Jewel Soft Tissue Reinforcement Device (102-6005)
- K242818 — IsoSphere
- K250119 — Tempus ECG-Low EF
- K250181 — AV Viewer
- K250350 — Thrive 2-in-1 Breast Pump (Model P3)
- K251045 — Disposable Neonatal NIBP Cuff (4 models)
- K251053 — Shinetell PlusTM Digital Early Pregnancy Test
- K251844 — Kerecis SurgiBind (50241)
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K250120 — GECHO
- K250185 — Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
- K250504 — Leonardo Duster
- K250660 — LUMINOS Q.namix T; LUMINOS Q.namix R
- K251096 — PeekMed web
- K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
- K251173 — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
- K251378 — CoolTone
- K251488 — FLOWRUNNER Aspiration System
- K251554 — Materialise TKA Guide System
- K251850 — Phantom® Hindfoot TTC/TC Nail System
- K243598 — Welch Allyn Connex® 360 (Multiple)
- K243199 — NightWatch+ US
- K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
- K243227 — B-Scan
- K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
- K243296 — Disposable Biopsy Needle
- K243655 — TurbAlign
- K250034 — Natural rubber latex male condom
- K250156 — Choice 2 DC
- K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401)
- K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort)
- K250761 — KALA Therapy Wand (Model: KALA-03)
- K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K250820 — Disposable Trocars
- K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
- K251134 — RipCord
- K251149 — AviClear Laser System
- K251155 — BD Cathena Safety IV Catheter
- K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) +1 more
- K251436 — Resolve Anterior Cervical Plate System
- K251470 — ResiCem EX
- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K251482 — AEON Endoscopic Powered Stapler
- K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
- K251808 — Achieva +10 more
- K243252 — ZBPro Diagnostic
- K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101)
- K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit
- K250063 — ARENA Star, Galaxy Star
- K250072 — CONDUIT SYNFIX Evolution Secured Spacer System
- K250283 — RAP Femoral Venous Cannulae
- K251145 — Arthrex PushLock Suture Anchors
- K251169 — Vivid Pioneer
- K251830 — Sonosite LX Ultrasound System
- K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
- K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243500 — ARCHITECT iGentamicin
- K243731 — HEXIM Implant; Samwon General Abutments
- K250108 — OptiVu Shoulder
- K250133 — HARBOR Occlusion Device
- K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
- K250247 — panaSIa SI Fusion System
- K250505 — EZ-FIDUCIALS
- K251520 — Cios Alpha; Cios Flow
Data sourced from openFDA. This site is unofficial and independent of the FDA.