FDA 510(k) clearances — page 14
clearances on record, most recent first.
Clearances — page 14
1,301–1,400 of 176,428- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K261405 — ANDI 2.2
- K252930 — AQUA Laminoplasty Systems
- K253130 — Dione PEEK Screw System
- K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- K253971 — Visby Medical Flu and COVID-19 Test
- K254075 — Synapse Lung Nodule AI
- K254102 — Glucommander
- K254104 — ResScan Essentials
- K254265 — Helion Viewer Suite
- K260123 — EPIQ Series Diagnostic Ultrasound System
- K260142 — StimelMD (SSMD) system
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K260367 — Portable Dental X-ray System Model PDX nova
- K260646 — RENASYS EDGE (66803126)
- K260680 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K261374 — LigaPASS System
- K252790 — Digital ClarusScope System and Digital NeuroPEN System
- K252797 — JAZBI Resorbable Bone Void Filler
- K252833 — VIVA combo RF System
- K253629 — Momcozy Nasal Aspirator (BN007)
- K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
- K260318 — 4K NIR/ICG Imaging System
- K260398 — LOGIQ e
- K260183 — MediBot Needle Driver Uno
- DEN250057 — PCWP Analysis Software
- K252735 — C-beam
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K252784 — eXaSkin Plus
- K252887 — DePuy ATTUNE Knee System
- K252915 — AiSteth®
- K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K253359 — Zenith Distal Access Long Sheath
- K253569 — Atmo Gas Capsule System
- K253773 — Guanhong Sharps Container (13+ models)
- K253949 — SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
- K254129 — Spectrum-2
- K254137 — InQwire Amplatz Guide Wire
- K260113 — uMR Astra
- K260189 — MagVenture Accelerated TMS (aTMS) Therapy System
- K260324 — Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
- K260329 — Ion-C Navigation Instruments
- K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System
- K260695 — da Vinci Firefly Imaging System
- K261098 — TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- DEN250028 — DeepView AI® System
- K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
- K252746 — Atlan (4 models)
- K253112 — Sofjec (3 models)
- K253191 — DCMhotbond zircon
- K253245 — Boston 2910 (Boston 2910)
- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K253720 — uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
- K253816 — MuCover (proposed name) Oral Wound Dressing
- K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
- K254131 — BAC
- K254141 — Manual Wheelchair (DY01903(2))
- K254244 — Wearable Breast Pump (Model S39)
- K260066 — PanopticAI Vital Signs (1.6.1-22)
- K260068 — pjur NATURE Touch, 100 ml
- K260234 — MSK Go
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K260582 — ROSA® Shoulder System
- K260618 — Ulthera® System
- K260649 — OES ELITE Cystoscope and Accessories +11 more
- K260962 — Sphincterotome
- K261291 — Nisus NPWT Canister 500-mL (CPC-500)
- K261315 — Symbia Pro.specta Q3 (11364751) +3 more
- K261325 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
- K261359 — Stelo Glucose Biosensor System
- K252707 — Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
- K252717 — MAASTRO Rectal Applicator Set
- K253134 — LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
- K253570 — Blood Pressure Monitor (W06LT)
- K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0
- K253774 — Elos Accurate® Denture Fixation System
- K253911 — Derma-2
- K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
- K260304 — WAVE PTA Balloon Catheter
- K260351 — Numen Helia Coil Embolization System; NumenFR Detachment System
- K260594 — IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
- K260717 — Mobility Scooter (Air Carbon)
- K261286 — The Circadia C300 System (C300)
- K251270 — Taperloc® Complete Hip Stem
- K252985 — Laport
- K253309 — SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) +1 more
- K253722 — LIAISON PLEX Gastrointestinal Flex Assay
- K254024 — MR5 Activ Pro
- K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM
- K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck
- K260577 — FilmArray TF Control Panel M527
- K261071 — DIAFIL Bulk FLOW (3 models)
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K253295 — Coude Sleeved IC; Coude Plus Sleeved IC
- K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more
- K253831 — CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
- K254109 — G-CEM UNIVERSAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.