FDA 510(k) clearances — page 152
clearances on record, most recent first.
Clearances — page 152
15,101–15,200 of 175,699- K211886 — Clivia series Diagnostic Ultrasound System
- K212578 — Nitrile disposable examination gloves
- K212740 — Puravita Medical Fold Flat Surgical Mask
- K212802 — powder free nitrile examination glove - white, non-sterile
- K212907 — Aimanfun Lumea Comfort, A-2789/A-3588
- K212950 — FUJIFILM Video Laparoscope EL-R740M30
- K210934 — Sphincterotome / short-wire compatible, Sterile Sphincterotome
- K211755 — Electric Breast Pump
- K211959 — Milli Vaginal Dilator
- K212050 — NGM WAVE PLIF Cage
- K212326 — AC Cream - Conductive paste
- K212789 — Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
- K212804 — Powder free nitrile examination glove- blue, non-sterile
- K212864 — dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
- K213305 — Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
- K202024 — ARROW Short Stem Humeral System
- K210117 — Paltop Narrow Implant
- K210836 — InstruSafe Instrument Protection System
- K211668 — KardiaMobile Card
- K211696 — Disposable Surgical Face Mask
- K212664 — Sherlock
- K203748 — SeptiCyte RAPID
- K210930 — ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
- K212237 — 3D-Cut
- K212762 — geko W-2
- K212814 — C2 CryoBalloon Ablation System
- K213226 — RCT700
- K202537 — ALTMS Magnetic Stimulation Therapy System
- K202842 — Medical surgical mask
- K210782 — Tablo Cartridge
- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- K211139 — CUBE Air Purifier
- K211541 — MammoScreen 2.0
- K211594 — Trevo Trak 21 Microcatheter
- K212488 — Synthetic Nitrile Examination Gloves
- K212722 — Nitrile Examination Gloves
- K210009 — Guiding Catheter
- K211169 — Bronchoscope System
- K211295 — Surgical Mask (sterile)
- K211345 — C-30 Crown Kit
- K211463 — Regulora
- K211650 — The Radian MIS Bunion System
- K211744 — Non-Contact Infrared Thermometer, model HL710H
- K211894 — Trachealator
- K211983 — AMRA Profiler
- K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)
- K212558 — MicroPen EVO
- K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
- K213214 — Xpert Wrist
- K213455 — ControlRad Select Model Z
- DEN210012 — vPatch
- K202445 — Hystero-V Hysteroscope
- K203248 — Albumin BCG2
- K210095 — Playboy Premium Silicone Lubricant
- K211342 — Sofia 2 Campylobacter FIA
- K211347 — Uretero1 Ureteroscope System
- K211387 — Breathe Easy Mobile Respiratory Monitor (MRM)
- K211432 — Myomics Q
- K211562 — Virtue RF
- K211649 — PCEA Syringe Set
- K211765 — Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
- K211956 — 039 Surgical Face Mask
- K212101 — da Vinci SP Firefly Imaging System
- K212150 — Exablate Prostate System
- K212169 — Air compression therapy system FO3002
- K212529 — Hypotension Decision Assist Model HDA-OR2
- K213184 — MZ Skin LightMAX Supercharged LED Mask 2.0
- K213454 — Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
- K210265 — VS3 Iridium Sytem
- K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- K210990 — Non-sterile Powder Free Nitrile Examination Gloves
- K211168 — Philips Incisive CT on Trailer
- K211651 — Eclipse PRO
- K211741 — Pre-Formed Extra Support Guidewire
- K211854 — VITA Akzent LC
- K211960 — Agile Esophageal OTW Stent System
- K212989 — Low-frequency Stimulator (Model: AST-645, AST-646)
- K213451 — Spartan MC 0165
- K202288 — Finebeam
- K203074 — Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
- K210573 — Velofix SA Cervical Cage
- K210831 — OnQ Neuro
- K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
- K211063 — HALYARD Flexaprene Green Powder-Free Exam Glove
- K211080 — EkoSonic Endovascular Device
- K211326 — EndoScreener
- K212015 — BD Nano 2nd Gen Pen Needle
- K212653 — Catalyft LS Expandable Interbody System
- K212661 — Disposable Nitrile Examination Glove
- K212673 — MR 5300
- K212697 — Leaf Smooth
- K213090 — Frontier Series Power Wheelchairs
- K213213 — Arthrex Vortex Threaded Bone Marrow Recovery Needle
- K213421 — Vector® Hammertoe Correction System
- K200091 — Capiox iCP Centrifugal Pump
- K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes
- K210350 — Gemini 2 810+980 Soft Tissue Laser
- K211662 — Reprocessed IntellaMap Orion High Resolution Mapping Catheter
- K211871 — FAICO Dental Implant System and CAD/CAM Abutments
- K211937 — SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Data sourced from openFDA. This site is unofficial and independent of the FDA.