FDA 510(k) clearances — page 94
clearances on record, most recent first.
Clearances — page 94
9,301–9,400 of 175,620- K232400 — VariSeed (v10)
- K232413 — Fusion Robotic Navigation System
- K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
- K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- K232457 — Q-FIX ULTRA All-Suture Anchor
- K232686 — CorVista® System
- K221743 — Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes
- K222823 — AeroDVx Arm System
- K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
- K230644 — Signum opaque F
- K230649 — Arm Blood Pressure Monitor
- K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- K231542 — Digital Blood Pressure Monitor WBP Series
- K231687 — Gradual Dental Zirconia Blank
- K231800 — IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
- K231828 — Pounce Sheath
- K231996 — Steriking® LT-Blueline Pouches with Tyvek®
- K231999 — Steriking® LT-Blueline Pouches with Tyvek®
- K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
- K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- DEN230006 — esolution
- K223575 — Phoenix ICON, Phoenix ICON GO
- K230024 — HI-EMT MAGSHAPE
- K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
- K230824 — IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
- K231717 — IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
- K232482 — MAGNETOM Viato.Mobile
- K200583 — Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
- K201869 — Ki Power Tilt System
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K221869 — BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
- K223684 — F&P 820 Humidification System
- K230743 — ICHOR 14F Embolectomy System
- K231819 — Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
- K232361 — Promaxo MRI System II
- K232691 — Polibond
- DEN230007 — LightStrike+ (MXSUV1-SL and MXSUV1-FT)
- K213273 — Brain Anesthesia Response Monitor (Bar Monitor)
- K213413 — Hemostatic Dressing
- K221601 — MS-39
- K222988 — neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
- K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK)
- K223674 — eZSURE Empty Fluid Container (models 426030, 426040, 426110)
- K223901 — ApneaRX Pro
- K230317 — Elos Accurate Hybrid Base
- K230623 — KITE Distal Fibula Kit
- K230805 — TriMed Clavicle Fixation System
- K230918 — MasterX 800 Series
- K231047 — UniSyn Molecular Imaging (6-3-1)
- K231270 — Montage Flowable Settable, Resorbable Bone Paste
- K231710 — OW100S
- K231884 — TRIOCLEAR System
- K232014 — CONDUIT ATP Inserters
- K232021 — Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
- K232068 — HyperLight Portable X-ray Unit
- K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
- K232334 — DEKA SIMON
- K232340 — Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
- K232657 — InnerView LC
- K213271 — MedicloseTM System
- K221959 — Q21
- K222563 — BD Kiestra IdentifA
- K223527 — Little Wave Clik, Rogue XP, Little Wave XP, Spark
- K223533 — Little Wave Arc; Little Wave Flip
- K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- K230488 — EL27-Compact; Sterile EHL-Probes
- K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- K231323 — Ancora-SB
- K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
- K231611 — HOLO Portal Surgical Guidance System
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K231626 — OSPREY Closed IV Catheter System (OspreyV2)
- K231978 — BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50
- K232287 — RAYSCAN a-Expert3D
- K232353 — Powder Free Nitrile Examination Gloves (Black)
- K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
- K223303 — Spinery RF Ablation System
- K223367 — Ochsner Connected Inhaler Sensor
- K223468 — Nexis® compressive screws
- K230013 — Silk'n Titan Allways
- K230155 — Mick Valencia Applicator Set
- K230355 — Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR
- K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
- K231024 — AquaBeam Robotic System
- K231093 — AlphaVent Suture Anchors
- K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
- K231156 — Enzyme Packed Cartridge - RELiZORB
- K231246 — Ventrax Delivery System (VTR851)
- K231276 — SmartCardia 7L Platform
- K231289 — S-Patch Ex Wearable ECG Patch
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K231656 — Brainomix 360 e-MRI
- K231961 — NIBPCuff
- K231988 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
- K232295 — LAA Exclusion System
- K232324 — StealthFix Intraosseous Fixation System
- K232343 — AC3 Series IABP
- K221361 — circul pro Ring
- K230765 — Precice Ankle Salvage System
Data sourced from openFDA. This site is unofficial and independent of the FDA.