FDA 510(k) clearances — page 96
clearances on record, most recent first.
Clearances — page 96
9,501–9,600 of 176,479- K230849 — ELLAVI UBT
- K231118 — Cystoscope System
- K231937 — Foundation Dermal Regeneration Scaffold (DRS) Solo
- K232083 — BriefCase-Quantification
- K232240 — Microwave Ablation System (BD-GT)
- K232241 — Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)
- K232257 — Clarius Bladder AI
- K232488 — Accu-Chek Safe-T-Pro Plus Lancing Device
- K232509 — Accu-Chek Safe-T-Pro Uno Lancing Device
- K231564 — Skin and Wound Cleanser
- K222780 — LILY Extension Tube and Needleless Connector
- K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K223754 — BraveCX
- K230828 — Flowflex COVID-19 Antigen Home Test
- K230969 — Oxygen Concentrator
- K231150 — Cardio P1
- K231277 — TissueStat
- K231366 — Neuronaute Plus
- K231508 — Power Wheelchair, W5521
- K231617 — MAGNETOM Free.Max; MAGNETOM Free.Star
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231752 — ARK Hydrocodone Assay
- K231804 — PRIME-XV FreezIS DMSO-Free MD
- K231911 — Glenoid Reconstruction System Full Wedge Baseplate
- K231920 — Longeviti ClearFit OTS Cranial Implant
- K232442 — Disposable Endoscope Injection Needles
- K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit
- K233366 — SYMPHONY OCT System
- K233408 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K233596 — VarseoSmile TriniQ
- DEN220091 — Dream Sock
- K223739 — VS Tabletop Tonometer
- K230400 — Cure Catheter Closed System; Cure Dextra Closed System
- K230534 — BriefCase-Quantification
- K231765 — Contour ProtégéAI
- K231773 — Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
- K231798 — da Vinci SP Surgical System
- K232152 — NerivioInfinity
- K232886 — INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
- K231155 — Biodegradable Medical surgical mask
- K231966 — LOGIQ E10
- K231989 — LOGIQ E10s, LOGIQ Fortis
- K232292 — Peridot-EX Expandable Intervertebral Body Fusion System
- K232476 — Disposable Sphincterotome
- K232866 — Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
- K233420 — Axium Detachable Coil; Axium Prime Detachable Coil
- DEN220090 — EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- K231316 — Aptima Trichomonas vaginalis Assay
- K231470 — Lunit INSIGHT DBT
- K231519 — Revital Cady
- K231865 — Mouth Guard (ATG0603R)
- K232857 — KARL STORZ ICG Imaging System
- K230078 — TRAX® CR Total Knee System
- K230100 — SCIZER (SC1-M410)
- K230343 — ProSeal Closed System Administration Set
- K230475 — Medical Video Endoscope System
- K230481 — Evenflo Premium Double Electric Breast Pump (Model 4018)
- K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- K231254 — GripTract-GI Endoscopic Tissue Manipulator
- K231440 — Combo Electrotherapy Device
- K231569 — ManaFlexx 2 (model: MF002-RX, MF002-OTC)
- K231586 — Endophys Blood Pressure Monitor model BPM-30
- K231918 — Freedom60 Infusion Pump +4 more
- K231955 — aprevo® Digital Segmentation
- K232113 — Halcyon, Ethos Radiotherapy System
- K232186 — LOGIQ e
- K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
- K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K232380 — t:slim X2 Insulin Pump with Interoperable Technology
- K232382 — Control-IQ Technology
- K232742 — Arthrex FiberTak Suture Anchor
- K233428 — Easycess Aspiration Pump
- K230326 — ENFit to ENFit Extension Sets
- K230800 — XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
- K232029 — VersaWrap Nerve Protector
- K232076 — Fibercure
- K232176 — STELLAR Knee
- K232345 — ATEC Posterior Navigated Disc Prep Instruments
- K232532 — Nd:Yag Laser Therapy Systems
- K232725 — Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
- K233056 — EpiZact
- K233062 — BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more
- K233518 — BASE290 LED Curing Light
- K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K231414 — CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
- K232730 — Aventus Thrombectomy System
- K232880 — Inzii Ripstop Redeployable Retrieval System
- K233402 — Bard 3DMax Mesh
- K233502 — TERA HARZ II
- K230083 — SAFIRA
- K230328 — Speedboat Flush SB1 Instrument
- K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail
- K230602 — Hudson RCI® TurboMist Nebulizer System
- K230814 — VRNT
- K231238 — Ultravision2 System
- K231243 — Finger Clip Pulse Oximeter
- K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S)
- K231362 — OCS Heart Leukocyte Depleting Filter
- K231629 — 091 Balloon Guide Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.