FDA 510(k) clearances — page 178
clearances on record, most recent first.
Clearances — page 178
17,701–17,800 of 176,479- K202387 — Disposable Surgical Face Mask
- K202462 — SIGMA Sterilization Pouch and Roll
- K202607 — Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs
- K202915 — IRIS Thermocoagulator and Digital Colposcope
- K203314 — Cartesion Prime (PCD-1000A/3) V10.8
- K203502 — MEDO-Thyroid
- K203605 — SteriTrak
- K203735 — Brainsway Deep TMS System
- K203835 — MIS Solution
- K203854 — Pulse Oximeter
- K210007 — Face Mask
- K210030 — Medical Surgical Mask
- K210312 — PlutoX Digital Intraoral X-Ray Imaging System
- K210345 — 2MP Monochrome LCD Monitor MS-S200
- K210626 — SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
- K210885 — Dayspring
- K210890 — GPS Cervical Spacers
- K210996 — ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- K211190 — 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
- K200329 — IDCAM Dental Implants
- K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
- K203353 — DVT-PRO
- K203365 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
- K203570 — Mya Joy PLUS Breast Pump
- K203646 — Disposable Medical Face Mask
- K210065 — Verifine Safety Type Insulin Pen Needle
- K210482 — Medline UNITE REFLEX Nitinol Staple System
- K210525 — MY01 Continuous Compartmental Pressure Monitor
- K210549 — ARx Spinal System
- K210893 — Restoration Anatomic Shell
- K202639 — si-Mochi
- K202750 — Knee+
- K202759 — Disposable medical surgical mask
- K203533 — VASSALLO GT
- K210145 — Nitrile Glove Powder Free Blue
- K210483 — MOBIO Total Knee System
- K210556 — Preview Shoulder
- K210580 — InnovaMatrix FS
- K210851 — DiLumen Endolumenal Interventional Platform (DiLumen)
- K210867 — NuEra Tight RF, NuEra Tight RF Plus
- K210961 — U2 Total Knee System, XPE Tibial Insert, PS PLUS
- K210988 — Yushan X-Ray Flat Panel Detector with DROC
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
- K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay
- K203596 — Panthera Occlusal Appliance
- K203610 — Automatic Anatomy Recognition (AAR)
- K203805 — Disposable Nitrile Examination Gloves
- K210157 — SOLE Medial Column Fusion Plate
- K210427 — M.U.S.T. Midline Cortical (MC) Screw System
- K210835 — Identify
- K210839 — SoundBite Crossing System - Peripheral (14P)
- K202506 — Karma Powered Wheelchair
- K203421 — Triathlon AS-1
- K203469 — AI Segmentation
- K203473 — SOZO
- K203495 — Arthrex SwiveLock Anchor
- K203644 — Solevy Co. LLC Silicone Based Personal Lubricant
- K203654 — Solevy Co. LLC Water-Based Personal Lubricant
- K203824 — VPS Impression Material
- K210121 — ROSA Partial Knee System
- K210134 — Dentis s-Clean s-Line
- K210420 — Goblin and Goblin LS Pedicle Screw Systems
- K200270 — rainbow MCT
- K200271 — rainbow CT
- K200978 — Electric Wheelchair (Model: S7110)
- K201047 — Fusion Taper System
- K202055 — Looper (Model: ZX-579S)
- K202419 — BIOTECH Nitrile Examination Gloves
- K203170 — Infrared Thermometer Models: DT-8806S, DT-8807S
- K203517 — Saige-Q
- K203616 — Brainsway Deep (DTMS) System
- K210169 — Hair Growth Device
- K210276 — Disposable Nitrile Gloves
- K210600 — MOLLI
- K201718 — GD Disposable Medical Face Mask
- K202403 — SKORE (Colors & Flavors), SKORE (Colors)
- K202830 — Axiostat Patch
- K203132 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K203315 — BLUEPRINT Patient Specific Instrumentation
- K203364 — MDPC-8127
- K203701 — Locator Overdenture Implant System
- K210235 — Verrata PLUS Pressure Guide Wire
- K210338 — Edge Insulated Blade Electrode
- K210539 — CoreLink Midline Fixation System
- K210808 — Instylla Microcatheter 1.2
- K201127 — DEFEND Ear-loop Face Masks
- K201138 — AMSure® Single Use Saline Topical Solution
- K202617 — Metapex Plus
- K202992 — BriefCase, RIB Fractures Triage (RibFx)
- K203390 — Artimes pro Balloon Dilatation Catheter
- K203449 — F&P Visairo NIV Mask Range
- K210493 — CX30N (CX30PQX)
- K210752 — HydroMARK Breast Biopsy Site Marker
- K210754 — Cannulated Fasteners and Nuts
- K202136 — IDS Cortisol
- K202884 — SR-1 Skin Treatment System
- K202906 — EndoPilot2
- K203500 — RetCam Envision
- K210088 — 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
Data sourced from openFDA. This site is unofficial and independent of the FDA.