FDA 510(k) clearances — page 153
clearances on record, most recent first.
Clearances — page 153
15,201–15,300 of 176,479- K213091 — Well-Life TENS/EMS/Heating Stimulator
- K213286 — EONS Nitrile Examination Gloves Powder Free
- K213600 — Medical nitrile examination gloves (Model: SH001)
- K213912 — Disposable Medical Nitrile Examination Gloves
- K214110 — Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs
- K201510 — Traufix osteosynthesis, osteotomy, and arthrodesis devices
- K202644 — Acetaminophen
- K211746 — Pocket Ultrasound System
- K212212 — Multitom Rax with True2scale Body Scan Option
- K212447 — SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
- K212627 — True Tulip, True M.I.S.
- K213057 — ExamVue Duo
- K213079 — Ear Thermometer, Model ET001
- K213306 — Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs
- K213319 — Viz ANEURYSM, Viz ANX
- K213440 — Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
- K213503 — Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E
- K213634 — Vinyl/Nitrile Blend Exam Glove
- K213688 — Nitrile Examination Gloves (Model: ZMG1351)
- K213999 — Deep Learning Image Reconstruction
- K214003 — Dental Zirconia Pre-shaded Block
- K214005 — Zirconia Dental Ceramics
- K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
- K210208 — Titan Condoms
- K210864 — Safety Pen Needle
- K211212 — LoFric Elle
- K211679 — Xtractor device
- K212586 — Amazing+
- K212824 — Bluezone Model RX-450 Air Purifier
- K212977 — SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
- K213107 — Powder Free Blue Nitrile Examination Gloves
- K213625 — Vinyl Examination Gloves
- K213647 — Durex Patronus Wide
- K213689 — Voluson P6, Voluson P8
- K213710 — da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
- K213972 — Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
- K213982 — Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
- K214022 — Accu-Chek Softclix Blood Lancing System
- K220124 — YandR System, VoluDerm Handpiece, VoluDerm Tips
- K220137 — Lunderquist Extra Stiff Wire Guide
- K220150 — TENS & PMS (Model: SM9126)
- K220277 — Digital Intraoral X-ray Sensor
- K212886 — Broncoflex Agile, Broncoflex Vortex, Screeni
- K212930 — LumiVy Lumbar IBF System
- K213186 — NovoFlow Reinforced Ureteral Stent
- K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K214044 — 14HQ901G-B
- K220136 — Treace Medical Concepts (TMC) Plating System
- K220147 — Aspiron S ACP System
- K220419 — Apapro Desensitizer
- K203234 — t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
- K210229 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K210636 — Morpheus
- K203793 — RithmID-SD Steerable Diagnostic Electrophysiology Catheter
- K211610 — Fogarty Occlusion Catheter
- K212011 — Vinyl Powder Free Examination Glove
- K213606 — EvoEndo Single-Use Endoscopy System
- K213622 — Cionic Neural Sleeve NS-100
- K203337 — PainTB, PainTJ
- K211024 — Electric Breast Pump
- K211248 — ArtUs
- K211400 — Pulse Oximeter
- K211712 — 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
- K212180 — Wearable Breast Pump (Model S12)
- K212545 — FlexitSystem Knee osteotomy system
- K212570 — OsteoPlan System
- K212622 — Zyter RPM
- K212885 — Actively Trying Personal Lubricant Rose Scented
- K213328 — Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
- K213462 — EzRay M18 (Model: VMX-P400)
- K213487 — ACUSON P500 Ultrasound System
- K213603 — SIGNA Artist Evo
- K213617 — Surgical Face Mask
- K213664 — B. Braun Introcan Safety 2 IV Catheter
- K213874 — MAVERICK External Fixation System
- K213890 — IMICRYL Impression Materials
- K202234 — NervAlign Nerve Cuff
- K202728 — Action Trackchair Hawk
- K202926 — Micro Catheter
- K203811 — GPC Intraheal Intramedullary Nailing System
- K211327 — Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
- K211570 — Zeolite Hemostatic Gauze
- K212971 — NPseal
- K213632 — Instylla Delivery Kit
- K220007 — Pure-Vu EVS System
- K211617 — Infrascanner
- K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
- K212211 — Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
- K212213 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
- K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System
- K212705 — Actively Trying Personal Lubricant Unfragrance
- K213297 — Redline
- K213311 — Lucy Breast Pump
- K213313 — Veinoflow SCD (Model: LBTK-M-I 5006)
- K213573 — PELNAC Wound Matrix
- K213918 — DeGen Navigated Instrumentation
- K214011 — Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers
- K220108 — SDC4K Information Management System with Device and Voice Control Package
- K211530 — PathBuilder Steerable Introducer
- K213058 — O'Star Nitrile Examination Gloves Powder Free
Data sourced from openFDA. This site is unofficial and independent of the FDA.