FDA 510(k) clearances — page 116
clearances on record, most recent first.
Clearances — page 116
11,501–11,600 of 175,620- K221693 — Elecsys Anti-HCV II (08837031190)
- K222045 — Wearable Breast Pump (Model S1DW)
- K222182 — Radial Artery Compression Tourniquets
- K222221 — DEKA HELIX
- K222483 — Surgical Face Mask
- K222907 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
- K223685 — SmoothCool HR System
- K220847 — AETOS Shoulder System
- K222809 — Medical Disposable Face Masks
- K223378 — 3.0T 16ch AIR AA
- K223775 — EZ-STIK Electrodes
- K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
- K213260 — CMFlexTM
- K213430 — Fingertip Pulse Oximeter
- K214041 — Aesculap AICON Container
- K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
- K221796 — Cyware 4H and Cysart 4H
- K222002 — Persyst 15 EEG Review and Analysis Software
- K222010 — Biobeat Platform-2 and BB-613WP Patch
- K222195 — aprevo® Digital Workflow
- K222767 — PeekMed web (v1)
- K222872 — DNA Appliance
- K223605 — ControlSeal Electrode (ELSB)
- K223616 — Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K223687 — X-ray Flat Panel Detectors (EverestView 4343X)
- K211557 — EndoPATx
- K211619 — Multi-Parameter Patient Monitor
- K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- K221333 — Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
- K221477 — AG100s
- K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- K221859 — Atalante
- K221981 — SafeR Syringe and SafeR Sting
- K222528 — Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
- K222984 — BioClean Implant Restorative System
- K223324 — Total Bilirubin2
- K223592 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K223603 — Reflow System Mini and ReFlow Mini Flusher
- K223647 — CLEAR+BRILLIANT TOUCH® Laser System
- K221344 — nView s1 with nav option
- K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
- K222760 — StageOne Select Hip Cement Spacer Molds
- K223286 — BD AutoShield Duo Pen Needle
- K223654 — Medussa-PL Cage
- K220974 — R:GEN
- K221669 — IOB Warming Blankets
- K221990 — Access Total ßhCG (5th IS)
- K222978 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- K223094 — EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License
- DEN220017 — BioXmark
- K210017 — ACTOnco, ACTOnco IVD
- K211485 — STA- NeoPTimal
- K212239 — XENOVIEW 3.0T Chest Coil
- K214002 — CRYOcheck Chromogenic Factor IX
- K214036 — AVIEW
- K221048 — Episealer Patellofemoral System
- K221193 — OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
- K221708 — CIMILRE Free-T2 Plus
- K221765 — ONLINE DAT Benzodiazepines II
- K222164 — Visant Medical Canalicular Plug
- K222726 — Smartpump 3.0 Double Electric Breast Pump
- K222748 — ShiNeo Silicone Implant
- K222924 — Leg Massager RF-ALM070
- K223071 — Xenoview VDP
- K223289 — Access Vitamin B12
- K223442 — MR 5300 and MR 7700 R11 MR Systems
- K223565 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
- K211058 — Lp(a) Ultra
- K221377 — SteriKing LT-Blueline Pouches with Tyvek
- K221396 — Arthrex FiberTak Suture Anchor
- K221428 — PerioStom Dental Dressing
- K222216 — TruWave Disposable Pressure Transducer
- K222262 — Sunrise
- K222774 — iFuse Bedrock Granite® Implant System
- K222806 — Kodiak C Spinal Implant System
- K222894 — Invisalign System, Pre-Formed Attachment System
- K222949 — Air Compression Leg Massager (Model: LY-670D)
- K223105 — Tesera-K SC System
- K223142 — Coltolux Comfort LED Curing Light
- K223273 — ASTRA Spine System
- K223311 — Philips CT 3500
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K223547 — Biograph Vision Quadra PET/CT System
- K223649 — VERTICALE® Navigation Instruments
- K202965 — CURA-Temp
- K213235 — PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
- K213564 — BiWaze Clear System
- K213875 — DRI TM Tricyclics Serum Tox Assay
- K213893 — Comfort Gown, Safewear Gown
- K220012 — BresoDX1
- K220286 — ELECTROCYN soma
- K221054 — CORE-INJECTOR
- K221221 — Advanced Intramedullary Nail System
- K221698 — Eargo 5 , Eargo 6
- K221720 — Extra Silver Gelling Fiber Dressing
- K221826 — BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
- K221902 — LimFlow Vector
- K221911 — VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
Data sourced from openFDA. This site is unofficial and independent of the FDA.