FDA 510(k) clearances — page 33
clearances on record, most recent first.
Clearances — page 33
3,201–3,300 of 176,479- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K253376 — OBSIDIO Conformable Embolic (M0013972101010)
- K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System
- K250618 — Medi Lift Essential Eye Mask
- K250882 — SANSA HSAT
- K251643 — Synchfix EVT
- K251772 — Navilas Laser System 577sl (156691)
- K251963 — LOGIQ E10s
- K251985 — LOGIQ E10
- K252314 — Arthrex SutureTak Suture Anchor
- K252390 — Telescope Guide Extension Catheter
- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K252697 — 3D Laparoscope
- K253153 — SER Pen Carain MicroSystem (MP1209SP)
- K253232 — Seguin Annuloplasty Ring
- K253242 — LCD Monitor (C1216W, C822W, C821W)
- K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
- K253314 — Freedom Infinia Total Knee System
- K253323 — Protrieve Sheath
- K253345 — JARVIS Diaphyseal Stem Standard
- K253355 — Difiney Advanced Anti Snoring Device 4.0
- K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch
- K251466 — VenAir, Sequential Compression System (9P-089000) +6 more
- K252165 — ZIRCONOMER P
- K252351 — UniSpace® TPLIF Cage
- K252376 — Yomi S Robotic System
- K252547 — TheraSphere 360 Y-90 Management Platform
- K252742 — Navigated Instruments
- K253300 — Fine Osteotomy
- K253399 — Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter
- K250297 — TECHFIT Patient-Specific Cranial System
- K250520 — OsteoCentric Navigated Instruments System
- K251027 — cvi42 Coronary Plaque Software Application
- K251331 — Blood Pressure Monitor (B73, BE23T)
- K251824 — Patriot Duo
- K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K252053 — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
- K252467 — Disposable Vinyl Examination Gloves
- K252629 — Electric Breast Pump (HL-3058, F5112)
- K252630 — Electric Breast Pump (HL-3060, F5113)
- K250345 — Medline Bag Decanter
- K250687 — Cocoon Solo (DX-7020s)
- K250696 — AccuCheck
- K250904 — Atalante X
- K251059 — Syngo Carbon Clinicals (VA41)
- K251312 — Vesalio Peripheral System
- K251372 — VersaD Delivery Catheter
- K251710 — Mobile X-ray unit (!M1)
- K251784 — Hushd Pro Z-Link
- K251827 — Azurion R3.1
- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components
- K252238 — CoroFlow Cardiovascular System
- K252357 — Glucose2
- K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
- K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- K252730 — Fule Spinal Fixation System
- K253106 — AngioVac Cannula
- K253125 — Parietene Flat Sheet Mesh
- K253129 — Infinity OCT System
- K253150 — Cryon-X Cold Compression
- K253188 — CoaguChek XS Plus System
- K253335 — CD Horizon Spinal System
- K253377 — Expandable Titanium PLIF/TLIF System
- K250288 — TeraRecon Cardiovascular.Calcification.CT
- K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
- K252309 — PerQseal Introducers
- K252345 — Picosecond Laser Device (PF131-BI)
- K252384 — DESS® Dental Smart Solutions
- K252425 — Silatrix Oral Gel
- K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- K252931 — Invisalign® Palatal Expander System
- K253100 — MultiPulse TFL
- K253226 — UV5000W Handle
- K250666 — Alegria Flash CTD Screen
- K250955 — XC11 ICE System, USA
- K251030 — Sirona Advanced Imaging Suite
- K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
- K251289 — WELLlife COVID-19 Antigen Test Rx
- K251628 — Mandibular Advancement Device L07
- K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K251977 — electric breast pump (3 models)
- K252298 — ANDI 2.0
- K252322 — SIros-X System
- K252325 — Hair Growth Laser Cap
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252569 — Carrier XL Delivery Catheter
- K253144 — Freedom® Total Knee System Titan PCK Components
- K253145 — Pre-Sutured Tendon
- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
- K231897 — NeuroAlign software
- K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
- K250394 — Fine TTO
- K250409 — Disposable Balloon Catheter (3 models)
- K250887 — Neuromuscular Transmission Monitor TOF3D (2510091)
- K251838 — Introducer Sheath Set
- K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
Data sourced from openFDA. This site is unofficial and independent of the FDA.