FDA 510(k) clearances — page 141
clearances on record, most recent first.
Clearances — page 141
14,001–14,100 of 176,479- K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
- K211150 — Dental diode laser, SOGA Laser, ILaser II
- K211176 — Smith & Nephew Hip Systems
- K213232 — NovaCore Semi-Automatic Biopsy Instrument
- K213315 — CROSSLEAD Peripheral Guide Wire
- K213385 — GEM
- K213488 — Bladder Scanner, Model Name:M5
- K213521 — Nihon Kohden NKV-330 Ventilator System
- K213871 — Ennovate Cervical Spinal and Occiput System
- K214050 — ENT Nasopharyngoscope and Accessories
- K220171 — NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
- K220248 — Home use hair removal device
- K220298 — CerroZone Mobile
- K220317 — PuraPly Micronized Wound Matrix (PuraPly MZ)
- K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
- K220660 — Prevena Restor Adapti-Form Dressing
- K220784 — AcQMap High Resolution Imaging and Mapping System
- K221025 — i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
- K221026 — Power Wheelchair
- K221036 — Astroglide Warming
- K221176 — Insulin Pen Needle
- K221395 — Footmotion Plating System
- K221625 — 2-Way 100% Silicone ClearTract Catheter
- K221909 — J-Temp
- K203597 — Cholesterol2
- K212418 — hCG One Step Pregnancy Test
- K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
- K213582 — Epicardial Access System
- K213913 — leva Pelvic Health System
- K213949 — VASSALLO GT 018 Floppy
- K220378 — Sparta 3-Ply Surgical Disposable Face Mask
- K220634 — NC TREK NEO Coronary Dilatation Catheter
- K220651 — Wrist Type Blood Pressure Monitor
- K221050 — ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
- K221569 — Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
- K221571 — InMode Multi-system
- K221750 — CPS AIM Universal II Slittable Inner Catheter
- K211016 — Powered Breast Pump (Models 7V and 7X)
- K213231 — Kerecis Silicone
- K213794 — Eko Murmur Analysis Software (EMAS)
- K220017 — Coloring Liquid
- K220289 — FridaMom Anti-Nausea Bands
- K220409 — ARTIS pheno (VE21) System
- K220410 — Ebony HP PTA OTW 0.035 Catheter
- K220432 — ARTIS icono (VE21) System
- K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
- K220834 — Powder Free Nitrile Examination Glove
- K220934 — RADIFOCUS Torque Device
- K220937 — Arthrex Mini Fragment System
- K220960 — BruxZir Opaque Coloring Liquid
- K220975 — V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
- K221286 — CLAROX
- K221312 — Diode Laser Hair Removal Device
- K221611 — 780 nm L11 LED Light Source with AIM
- K221714 — Flat Panel Detector
- K211076 — Patient Specific Marking Guides
- K211705 — 3M Attest Rapid Readout Biological Indicator, 1295
- K211718 — Venus Cervical Plate System
- K213478 — BD Pen Needle
- K213577 — VenAir, Sequential Compression System
- K213726 — PL-1 Skin Treatment System
- K220447 — Med-link Disposable ECG Cable and Leadwires
- K220449 — DePuy CONDUIT LLIF SQUID Inserter
- K220670 — Magnum
- K221195 — OsteoProbe
- K221256 — Mg OSTEOINJECT
- K221272 — Medical Face Mask
- K221273 — Medical Face Mask (M001)
- K210947 — Navident
- K213786 — CiRX Single use electrosurgical pencil with non-coated and coated electrode
- K213818 — VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
- K220309 — Wearable Breast Pump (Model S10)
- K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
- K220848 — Venue Fit
- K220851 — Venue
- K221233 — DT-703
- K200715 — RoughRider Aurora Manual Wheelchair
- K210852 — Noris Medical Dental Implants System - Cortical
- K212043 — TRAUS ENDO
- K212741 — EZYPOR
- K213114 — BentrioTM Allergy Blocker
- K213250 — Secret Duo
- K213439 — FlexBoardTM, EagleBoardTM, BreastBoard SXTM
- K213789 — Intelligence LaserComb
- K214123 — T-FIX® 3DSI Joint Fusion System
- K220300 — OTOPLAN
- K220377 — Procedure Mask
- K220575 — MAGNETOM Free.Max, MAGNETOM Free.Star
- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
- K220942 — 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
- K221524 — Sugita AVM Microclip Applier
- K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K201788 — EDEN Spinal Fixation System
- K211173 — maxmorespine Bipolar Electrodes
- K213194 — HD Mediastinoscope
- K213233 — EZYPRO ECG Recorder (Model: UG02)
- K213338 — CORE-CLIP
- K213349 — Catalyst R1 Reverse Shoulder System
- K213612 — SYLFIRM X
- K220494 — BreathID Hp Lab System, BreathID Smart System
Data sourced from openFDA. This site is unofficial and independent of the FDA.