FDA 510(k) clearances — page 80
clearances on record, most recent first.
Clearances — page 80
7,901–8,000 of 175,620- K233184 — T2Bacteria® Panel
- K233350 — SINC Support Catheter
- K233476 — Z1 Hip System
- K233480 — Access SHBG
- K233504 — Lexa MINI (RIS-303, RIS-305)
- K233914 — XVbeam2000
- K240069 — Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
- K240086 — Ion 3D
- K231956 — F&P Optiflow+ Duet Nasal Cannula
- K232171 — Purema® H Hemoconcentrator (EtO Sterilized)
- K232764 — Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K240064 — Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
- K240075 — FUJIFILM Endoscope Model EB-710XT
- DEN230041 — Sleep Apnea Feature
- K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap
- K233115 — Hawkeye Control Unit with Eyas Endoscope
- K233221 — Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K233416 — Cryojet Plus (SHE-ACP001-1)
- K233593 — MAGEC Spinal Bracing and Distraction System
- K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
- K233960 — INNOVERSE Spinal System
- K232363 — Viz HDS, Viz Volume Plus, Viz ICH+
- K232379 — PREVENT Kit
- K232694 — Central Monitoring System (MFM-CMS)
- K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
- K233600 — Smart Fit Knee 3.0T
- K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
- K234013 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- K234075 — Flow-Nail
- K240099 — Ziehm Vision RFD
- K232210 — X-trodes System M
- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K230548 — Myoaligner Appliance
- K231325 — Corplex P / Theracor P / Allacor P
- K231373 — BD Vacutainer® K2 EDTA Blood Collection Tubes
- K231534 — 5008X Hemodialysis System
- K231625 — VitalDetect
- K233143 — PiXel8-Reveal
- K233472 — CVAC Aspiration System + CVAC Image Processor
- K233531 — OIC FLEX-FIX System
- K233756 — Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
- K233855 — AllPEP
- K240030 — Indigo® Aspiration System - Lightning® Flash
- K230657 — BTL-99-OC
- K232007 — CAAS MR Solutions
- K232165 — Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
- 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 ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer
- 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 (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.