FDA 510(k) clearances — page 89
clearances on record, most recent first.
Clearances — page 89
8,801–8,900 of 176,479- K233855 — AllPEP
- K240030 — Indigo® Aspiration System - Lightning® Flash
- K230657 — BTL-99-OC
- K232007 — CAAS MR Solutions
- K232165 — Sterile Safety Hypodermic Needles for Single Use +2 more
- K232339 — Augmented Reality Application
- K232949 — Kelowna GYN and Crook Prostate Templates
- K233183 — Surgical Gown (40083)
- K233804 — Resonic Rapid Acoustic Pulse Device
- K240018 — WATCHMAN TruSteer Access System (M635TU90050)
- DEN210035 — Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- K214115 — MightySat -OTC
- K231396 — CEPHX- Cephalometric Analysis Software
- K232678 — Digital Thermometer, Model T28, T28L
- K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
- K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +7 more
- K240025 — Clearblue® Early Detection Pregnancy Test
- K231343 — Redemption Duo Hindfoot Nail System
- K231910 — DermRays Revive
- K232432 — E3D-A Interbody System
- K232942 — G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media
- K232986 — VariTrax Sternal CircumFixation System
- K234140 — VIVA combo RF System (VIVA combo RF System)
- K240020 — Ziehm Vision FD
- K230794 — Rebuilder Nerve Guidance Conduit
- K233394 — Gem Flow Now (GEM2770-FN)
- K233224 — Epilaser Pro
- K231282 — LifeOutcomes C-Quest Blood Culture Sampling Device
- K231303 — Arm-type Fully Automatic Digital Blood Pressure Monitor
- K231329 — Aptima Neisseria gonorrhoeae Assay
- K231715 — MONDRIAN Anterior Lumbar Plate System
- K231785 — Perifit Pump
- K232182 — One-Fil
- K232450 — Disposable Hemostatic Clips
- K232864 — EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
- K233299 — ExactechGPS® System
- K233485 — M-Wave
- K233508 — iFuse Bedrock Granite® Implant System
- K233598 — Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
- K234109 — Ziehm Solo FD
- K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System
- K234118 — CentriMag Acute Circulatory Support System
- K234145 — ViSiGi 3D Gastric Sizing Tube
- K232417 — MR Q; MR Q SUPINE; MR Q SLT
- K232665 — GentleCath Air for Women (3 models)
- K232912 — Facet Aurora Reusable Lancet Base
- K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
- K233714 — BreView
- K233735 — ADIRA Lateral Plate System
- K233893 — AlphaVent Knotless SP PEEK Anchor
- K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- K231607 — Axial3D Cloud Segmentation Service
- K233195 — Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
- K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
- K230836 — SchurSign Tissue Marker
- K231187 — Nano-Check COVID-19 Antigen Test
- K231305 — Endoform Dental Membrane
- K232673 — Dental Glass Ceramics
- 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 +17 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.