FDA 510(k) clearances — page 33
clearances on record, most recent first.
Clearances — page 33
3,201–3,300 of 175,620- K251297 — MIS LYNX Conical Connection Implant System
- K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251618 — MOTO Partial Knee System Extension
- K251955 — Onflex Mesh
- K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
- K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- K252010 — SPY Laparoscope
- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
- K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
- K243681 — Neuro Insight V1.0
- K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
- K250280 — SD TL Implant System
- K250590 — MAGiC Sweep EP Mapping Catheter
- K250716 — IMAGE ONE
- K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- K251213 — Da Vinci Surgical System (IS5000)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K251280 — DESS® Dental Implants
- K251748 — MammoSTAR Biopsy Site Identifier
- K243367 — Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
- K243415 — Granudacyn® Wound Irrigation Solution
- K243425 — Guided DAS Surgical Kit
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K243566 — CardioTag
- K244018 — Disposable Biopsy Needle
- K250211 — Yushan X-Ray Flat Panel Detector
- K250686 — GyriCalc (Version 1.0.0)
- K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K251255 — LymphaTech Mobile 3D Measuring Tool
- K251300 — Plastic Surgical Kits
- K251310 — OTS 25-L (100-5)
- K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
- K251616 — Clear Miracle
- K251638 — Mobility Scooter (MS160C)
- K251564 — microINR System
- K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
- K231562 — ELEC ENGINE (Model: ISE-170L)
- K243404 — HyHub and HyHub Duo Vial Access Devices
- K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL)
- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2)
- K250750 — INNOVISION-P5
- K250902 — HeartFlow Analysis
- K250952 — Baby Gorilla®/Gorilla® Plating System
- K250999 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
- 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 (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
- 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); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
Data sourced from openFDA. This site is unofficial and independent of the FDA.