FDA 510(k) clearances — page 81
clearances on record, most recent first.
Clearances — page 81
8,001–8,100 of 175,620- K232676 — Dental Porcelain Powder
- K232917 — Chemo Mouthpiece
- K233013 — 2-Way 100% Silicone Cleartract Catheter
- K230841 — NailLift
- K231299 — Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector
- K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
- K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
- K233887 — IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
- K234087 — restor3d TIDAL Lumbar Interbody Fusion System
- K233105 — RESPONSE Rib and Pelvic System
- DEN220009 — VerTouch Spinal Imaging Device
- K230133 — Plenity
- K230524 — Cold Compression Wrap Pro
- K230817 — TORPEDO Implant System®
- K231071 — Mix2Vial® Transfer Device
- K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel
- K231213 — HKT Anatomical Locking Trauma System
- K231218 — Distal Access Catheter
- K231237 — BD Vacutainer® Fluoride Blood Collection Tubes
- K231873 — DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
- K232156 — Rapid ASPECTS (v3)
- K232347 — MagnetOs Granules
- K232466 — Electric Breast Pump, model: YM-8166
- K232679 — Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
- K232783 — Power wheelchair (Model: JMPW-01W)
- K233142 — EndoSign® Cell collection device (ES-CYT-102)
- K233436 — IlluminOss Photodynamic Bone Stabilization System
- K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
- K233728 — SIGNA Champion
- K233736 — LifeSPARC System
- K221866 — S-Plant Dental Implant System
- K230592 — LuxCreo Dental Night Guard Resin
- K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
- K231405 — Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode
- K231416 — Air Next (NVD-02)
- K231573 — ThinkQA (Edition 2)
- K231762 — uEXPLORER
- K231860 — TDM Screw System
- K232373 — Progrip Self-Gripping Polypropylene Mesh
- K232577 — Radial Compression Device
- K232698 — NemoScan
- K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
- K233077 — FlashHeal 2 (FlashHeal 2.0)
- K233190 — ENFit Adaptor
- K233213 — NxStage PureFlow Solution
- K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
- K233447 — CeQur Simplicity On-Demand Insulin Delivery System
- K233451 — Arthrex Synergy Vision Endoscopic Imaging System
- K233507 — EVOLUTION® Tibial Cones
- K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter
- K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System
- K234011 — AMF TT Cones
- K234031 — Medline UNITE Ancillary Foot Recon Plating System
- K234040 — TriMed Threaded Intramedullary Nail System
- K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
- K231135 — Video Ureteroscope System
- K231871 — Radify Triage
- K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
- K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
- K233226 — FlexView Diagnostic (v1.1.20)
- K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
- K233710 — Symphion Operative Hysteroscopy System
- K233730 — Footprint Mini PK, 3.5mm Suture Anchor
- K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
- K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
- K234030 — Clear Guide SCENERGY
- K223234 — Delta4 Insight
- K223266 — Hilzo Esophageal Stents
- K231138 — Aniti-Snore Mouthguard+
- K231144 — Washtrays
- K232062 — Uni-port
- K232355 — Non absorbable Surgical Silk Suture
- K233293 — Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
- K233512 — Rapid (6.0)
- K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
- K233970 — Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
- K232350 — Stryker Facial iD System
- K233216 — CLEWICU System
- DEN220040 — Fibresolve
- DEN230008 — DermaSensor
- DEN230015 — Osteoboost Belt
- K222783 — MD Mattress Suture Placement Device
- K231315 — Velox Power Chair
- K231371 — BEE Cervical Cage
- K231558 — SMB Luer lock disposable syringe
- K231684 — Quick - Radius Disposable Set
- K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)
- K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
- K232032 — PROBEAT-FR
- K232170 — Ti Link Abutment
- K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
- K232970 — Hem-o-lok® Ligating Clips
- K232990 — ATOMIC Nitinol Fixation System
- K233020 — TauTona Pneumoperitoneum Assist Device (TPAD)
- K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
- K233114 — LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
- K233125 — Zirconia Block
- K233141 — SmartFrame OR
- K233144 — ClearPoint Bone Screw Fiducials
- K233155 — ClearPointer Optical Navigation Wand
Data sourced from openFDA. This site is unofficial and independent of the FDA.