FDA 510(k) clearances — page 30
clearances on record, most recent first.
Clearances — page 30
2,901–3,000 of 176,479- K251829 — DeGen Medical Patient Specific Implant (PSI) System
- K251936 — Ceribell Delirium Monitor System
- K252294 — Fetal EchoScan (v1.2)
- K252789 — Glass Ceramic
- K252862 — Electric Wheelchair (DH01126)
- K252994 — LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
- K243438 — MEMO Patch M (MPT-E08R-UNC01)
- K250512 — Augmented Gingival Matrix
- K250711 — VSP Orthopedics System
- K250743 — Remvia NightGuard
- K250764 — SpineLinc Anterior Cervical Implant System
- K250780 — ARTAssistant
- K250795 — PUREVUE FMS
- K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
- K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
- K251514 — Overjet CBCT Assist
- K251657 — Personalized Therapy Comfort Settings (PTCS)
- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
- K251731 — KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
- K252067 — Velora Acetabular System
- K252142 — Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K252151 — els unibond
- K252296 — OncoPatch
- K252465 — Any-Core
- K252494 — Electrically powered wheelchair (KZ301B)
- K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)
- K252504 — Gastric Alimetry
- K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
- K252825 — Manual Wheelchair (W45)
- K252828 — Manual Wheelchair (W47)
- K252841 — REAL INTELLIGENCE CORI XT (CORI XT)
- K253868 — QuietLab Pro
- K250679 — FFX Facet Fixation System
- K250791 — ASUS Ultrasound Imaging System (LU800 series)
- K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
- K251943 — Spineology Navigation Instruments
- K252126 — MitraPatch Mitral Valve Repair System
- K252429 — Vektor Computational ECG Mapping System (vMap®)
- K252588 — Mobility Scooter (T5)
- K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors
- K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
- K250692 — GentleBeam (GB1000)
- K250725 — Hugo RAS System
- K251203 — AVIEW Lung Nodule CAD
- K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem
- K251779 — Omnipod 5 algorithm
- K251881 — HippoMind (v1.0)
- K252213 — Bendit17 Microcatheter
- K253293 — VitaloJAK Clinic (Model 7100)
- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K250896 — Aura Wave
- K252021 — Disposable Endoscopic Injection Needles
- K252069 — da Vinci SP Surgical System (SP1098)
- K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- K251370 — Cartesion Prime (PCD-1000A/3) V10.21
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (4 models)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
- K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A)
- K252827 — IBP cable Becton Dickinson (2606488) +5 more
- K253250 — Minuteman® G6 MIS Fusion Plate
- K250636 — Sophy Mini Monopressure Valve (SM1)
- K252217 — CT VScore+
- K252658 — Medical Diode Laser Systems (TR-B)
- K253303 — Dendrite Imaging System
- K252760 — Carriere® Motion Pro® Clear Bite Corrector
- DEN240077 — MuReva OM
- K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
- K251058 — Tru Kidney Health Test Panel; Tru Analyzer
- K251674 — Fenom Flo FeNO Monitoring System
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K252000 — uDR Arria & uDR Aris
- K252248 — CEREC Tessera Abutment System
- K252260 — RELIEEV HSG Catheter (HSG7FA1)
- K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
- K252388 — Vanquish Water Vapor Ablation Device
- K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
- K253168 — 0.014 Willow Guidewire
- K253269 — OEC One CFD
- K250635 — FEops HEARTguide Simulation Application
- K250694 — Scaida BrainCT-ICH (v1.0)
- K251070 — Akura Thrombectomy System
- K251401 — PennPET Explorer Positron Emission Tomograph
- K251550 — NX01 (NX01)
- K251798 — RCT700
- K251932 — Spectra Platinum
- K252004 — enCore Night Guard
- K252161 — Hushd Avera
- K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
- K252289 — Eva Scalp Cooling System
- K252555 — Medusa Orthopedics Boa External Fixation System
- K252610 — ZSFab Lumbar Interbody System
- K252762 — HALO AP Dx
- K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
- K253219 — LeafPure-Echo (LM-LPNdA)
- K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
- K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
- K253344 — BELLUS-Q
- K253365 — LuxCreo Flexible Partial Denture Resin
Data sourced from openFDA. This site is unofficial and independent of the FDA.