FDA 510(k) clearances — page 150
clearances on record, most recent first.
Clearances — page 150
14,901–15,000 of 176,479- K213729 — Clover Glove
- K220215 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
- K220229 — Powder Free Nitrile Examination Gloves, Orange
- K202437 — Infusion Sets for Single Use
- K210037 — Pluski Safe 1 Safety IV Catheter
- K212153 — Biobeat Platform, BB-613WP Patch
- K212231 — C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
- K212263 — Luna G3 BPAP System
- K212395 — Nebulizer
- K213355 — Toro-L Interbody Fusion System
- K213562 — DTX Studio Clinic 3.0
- K213820 — BALTEUM - ONE Lumbar Plate System
- K213848 — Medical nitrile examination gloves (Model: JL001)
- K220187 — Medical Surgical Mask (Model: JM92, JM92B)
- K220242 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
- K220362 — LE-12CH
- K220600 — Artix Thrombectomy Device
- K220637 — 3 Ply Medical Grade Single Use Procedural Disposable Face Mask
- K202903 — Surgical Face Mask
- K211365 — Alio Medical Remote Monitoring System
- K212916 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile
- K213461 — AviClear Laser System
- K213492 — Dib UltraNav Transseptal Catheter System
- K213589 — FUBUKI XF Neurovascular Long Sheath
- K220196 — Steth IO Spot
- K220206 — Mobility Scooter
- K220207 — Mobility Scooter, Model W3468
- K220354 — Disposable Medical Synthetic Nitrile Examination Gloves
- K220453 — FlareHawk Interbody Fusion System
- K220519 — Erchonia Zerona Z-Bed
- K220629 — Emerge Monorail PTCA Dilatation Catheter
- K220655 — X-Pac Expandable Lumbar Cage System
- K210718 — LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
- K212625 — PathBuilder Transseptal Needle
- K212626 — PathBuilder Transseptal Guiding Introducer
- K212726 — Disposable Medical Surgical Mask
- K213568 — DRX-Rise Mobile X-ray System
- K213592 — Iridex 810 Laser
- K213616 — BD Surgiphor Antimicrobial Irrigation System
- K213860 — ArthroFree Wireless Surgical Camera System
- K214101 — Project E Beauty LED Light Therapy Mask (Model: PE730)
- K220178 — Total Immunoglobulin E (IgE)
- K220492 — COPAL exchange G hip spacer
- K220501 — Pounce Thrombectomy System
- K200828 — Athelas Home
- K210452 — Creatinine2
- K210693 — PLEXR PLUS
- K212960 — Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
- K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe
- K213678 — Powder Free Blue Nitrile Examination Gloves
- K214039 — LOGIQ P10, LOGIQ P9, LOGIQ P8
- K214103 — Shani Darden LED light therapy mask
- K220181 — StealthFix Intraosseous Fixation System
- K220511 — Medline UNITE IM Fibula Implant
- K203839 — WatchPAT200U (WP200U)
- K212999 — Multi-Functional Electrosurgical Knife
- K213200 — Solus Gold Embolization Device
- K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
- K213721 — BriefCase
- K220199 — AFFINITY Proximal Tibia System
- K203237 — Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
- K203530 — Albumin BCP2
- K210171 — Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
- K210823 — LYMA Laser
- K211132 — ARISTE AB Mesh
- K211438 — OPTRELL Mapping Catheter with TRUEref Technology
- K212371 — F&P Evora Full Face Mask
- K212498 — Stable-L Standalone Lumbar Interbody System
- K212891 — TempSure System
- K212939 — Vintage Prime Press
- K213563 — DePuy Synthes Radial Head Replacement System
- K213834 — Cardio Flow Peripheral Guide Wire
- K213965 — BeautiBond Xtreme
- K214016 — 15L Cycler Drainage Bag
- K220153 — Needle Stimulator (Model: RJNS6-1)
- K220228 — Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
- K220275 — EMERGE Anterior Cervical Plate System
- K220473 — CELERITY 20 HP Challenge Pack
- K220529 — Merits P335 Powered Wheelchair
- K220627 — SURGIVISIO Device
- K210315 — Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
- K210489 — SICtapered & SICvantage tapered
- K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
- K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
- K213948 — OxyMinder
- K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit
- K212623 — Healgen Strep A Rapid Test Strip (Throat Swab)
- K212851 — EchoSK and EchoSGyn modules for EchoS Family devices
- K213623 — iTEAR100 Neurostimulator
- K213779 — Customize
- K213823 — Intera Refill Kit
- K220324 — AccuFit Lateral 2-Hole Plate
- K220426 — Fiber Dust PRO
- K220726 — K Clear
- K212461 — VITEK MS PRIME
- K212709 — VoqX Electronic Stethoscope
- K212955 — Fit Pro Breast Pump
- K213121 — Disposable Nitrile Examination Glove
- K213314 — CerusEndo Microcatheter (027)
- K213980 — Peridot Spinal Interbody System
Data sourced from openFDA. This site is unofficial and independent of the FDA.