FDA 510(k) clearances — page 15
clearances on record, most recent first.
Clearances — page 15
1,401–1,500 of 176,428- K260100 — MOSES Raydar
- K260522 — RhinAer+ Stylus
- K260840 — BluEX Cervical Expandable Cage System
- K250781 — Embryo Predict
- K252377 — NxStage System One with NxView
- K252423 — NovaLine Tubing Set for Hemodialysis (BL 124)
- K252563 — Neurophet SCALE PET
- K252624 — KARL STORZ Laryngoscopes and Accessories
- K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- K253235 — Introcan Safety® Deep Access XL IV Catheter
- K253642 — Jada System (Jada-2002)
- K253716 — uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
- K253935 — medXion NEXUS
- K254028 — Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)
- K254050 — Manual Tissue Removal Device
- K254120 — SubtleHD-CT (1.x)
- K260059 — NOVEOS Specific IgE (sIgE) +8 more
- K260134 — Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 +1 more
- K260506 — Ventana® P/T Lumbar Interbody System
- K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
- K260771 — TruSelect 2.6 Microcatheter
- K260989 — Varion Thoracolumbar Fixation System
- K261264 — Stellaris Elite vision enhancement system +7 more
- K261273 — Neurophet AQUA
- K261289 — UNiD Spine Analyzer (SW3002)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252776 — ARIES Anterior Cervical Plate Systems
- K253078 — ART.1-US
- K253372 — ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
- K253676 — CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)
- K253883 — Bonalive Maxillofacial
- K254013 — SubtleHD-PET (1.x)
- K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- K254133 — ENTity USB Videoscope System
- K260085 — RAYMO Mobile X-ray System (Model: RAYMO)
- K260111 — Palmtop Ultrasound Diagnostic System (MT10P/MT10)
- K260485 — Any-Etch
- K260565 — SmartClip Delivery Catheter (ADR-1715)
- K260892 — Suction Pump (SU-90)
- K261134 — Dormiva Anti-Snoring Mouth Guard
- K261224 — MatriDerm
- K261241 — TriMed Compression Screws
- K261317 — BriefCase-Triage
- K252591 — Automatic Micro Needle System (CODE-X)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253061 — Portable Neuromodulation Stimulator (PoNS)
- K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform
- K253241 — Electric Wheelchair (Y207BL)
- K254073 — StatSeal Disc
- K254125 — Electric Breast Pump (HL-3058 II Pro)
- K260032 — Morph
- K261363 — Y-Knotless Flex Anchors
- K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
- K254192 — Senhance Ultrasonic System
- K260051 — CorVision® (91-205-Z0014)
- K260235 — CellDx-Tissue
- K260378 — Rayvolve
- K260415 — myLEDmask 2 (MJ-144)
- K260473 — Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
- K260837 — VersaLift Expandable System
- K260850 — OSTEOMNI SPINAL CAGES SYSTEM
- K261196 — Promisemed VeriEcto Automatic Biopsy Needles
- K250964 — Protable Phlegm Suction Unit (JMA D01)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K252880 — Pytheas Your Guided Trajectory
- K252953 — Velmeni for Dentists (V4D) Endo-Perio
- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more
- K254178 — SAYA 86 Radial Access Guide Catheter
- K254228 — KARL STORZ Trocars with Valve Seals
- K260196 — ETHICON Circular Stapler (CDH21mm) +7 more
- K260805 — Dual Core
- K260842 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K260846 — Diagnostic Ultrasound System (13+ models)
- K261214 — PICO SHINING (PICO-K; PICOFY)
- K260385 — aprevo® anterior and lateral lumbar interbody system +3 more
- K261145 — Avanti Distal Elbow ORIF System
- DEN250013 — Modius Spero
- K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
- K252617 — MiroCam® Capsule Endoscope System
- K252621 — DeepSkin (DEP100)
- K253013 — Disposable Stone Retrieval Balloon Catheter
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- K253396 — AYON Body Contouring System (AYON SYSTEM)
- K253679 — Hydro Irrigation System
- K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
- K254215 — Arthrex Beaming System
- K260321 — HipGuide (V 1.0.0.0)
- K260419 — LingOral Dental Design System
- K260788 — Smylio Aligners
- K260792 — AerFrame Patient Immobilization System (AFPIS)
- K253647 — Evita (V800); Evita (V600)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253826 — Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
- K253992 — Veritas Reverse Total Shoulder System
Data sourced from openFDA. This site is unofficial and independent of the FDA.