FDA 510(k) clearances — page 16
clearances on record, most recent first.
Clearances — page 16
1,501–1,600 of 175,620- K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions
- K253972 — IMAGE1 (TC400US); X-to-4U Adapter (TC040)
- K254007 — LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
- K260108 — L12 LED Light Source with AIM
- K260177 — Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
- DEN250007 — Delivery Date AI
- K251592 — SteriHub Disinfecting Device and Protective Cover
- K251813 — CURIS II RF Generator (REF 360100-05)
- K251992 — ArmSure Fluoroscopic Positioning System
- K252084 — AI4CMR v2.0
- K253032 — AXS Lift Intracranial Base Catheter
- K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
- K253488 — iFuse INTRA Ti Implant System
- K251515 — Solidex® Ti-Links and Screws
- K251672 — NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)
- K252175 — LANDR Contact LENS Case
- K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
- K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- K252751 — Earflo (EF001)
- K253140 — CollOvine Wound Powder
- K253545 — Vulcan Spinal System
- K254016 — MI View&GO
- K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
- K260119 — SpaceOAR Vue System (SV-2101)
- K251591 — Holter ECG and ABP system (HolterABP)
- K254033 — Ceribell Instant EEG Headset
- K254236 — Peel-Away Introducer Sheath
- DEN250006 — Amferia Wound Dressing
- K243348 — Athelas Home
- K243979 — Aptiva APS IgA Reagent
- K251218 — SafeBeat Rx App
- K251423 — Spectra S1 Pro; Spectra S2 Pro
- K251474 — Median LCS (internal name) / eyonis LCS (trade name) (1.0)
- K251507 — INTEGRE LIO
- K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII)
- K251577 — LAIA XR
- K251614 — Stainless Steel Surgical Kits
- K251836 — Dermatrix Duo
- K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP)
- K252076 — Kneevoice Cartilage Evaluation System (750-3600-001)
- K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
- K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
- K252873 — Q Interbody Instruments
- K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
- K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- K253780 — SIGNA Bolt
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K253927 — LiveMedica Enterprise PACS
- K251517 — Encora X1
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K253779 — SIGNA Sprint Select
- K253959 — Primevision 3D
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- K250773 — Luna® Ti Interbody Fusion System
- K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced)
- K252623 — G7® Revision Acetabular System
- K260012 — UltraScore Focused Force PTA Balloon
- K260038 — E3D-C Interbody System
- K260104 — Signature ONE System
- K250644 — MSS - Monobloc stem
- K252048 — 808nm semiconductor laser hair removal machine
- K252087 — Navigation Module of the Cortium® System
- K252438 — Explant Express
- K252676 — The Circadia C300 System (C300)
- K252909 — Diagnostic X-Ray Equipment Model POCT22
- K253282 — ZSmile System
- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K253701 — SmartGuard Technology; Predictive Low Glucose Technology
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K251200 — Vital Signs
- K251582 — Redermax Antibacterial Wound Matrix
- K252011 — CHIKAI Nexus petit
- K252286 — BIORES Dental Implant System
- K252649 — TAP2D
- K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
- K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- K251407 — Motor Handpiece and Control Unit (SDI10)
- K251769 — RevealAI-Lung
- K251981 — Boston PICO (Boston PICO)
- K252457 — Disposable Distal End Tape Hood
- K253318 — Clungene RSV Antigen Rapid Test
- K253671 — Dual Stage Venous Cannulae
- K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K254283 — BruxZir® Shaded 16 PLUS
- K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
- K254305 — BAROguard Donor Lung Preservation System
- K243732 — Multi-Unit DAS System
- K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits
- K251354 — UV Smart D60
- K251427 — EK MULTI ANGLED 30 ABUTMENT
- K251923 — Medical Shaver System (Morcellator) (YSB-IIIA)
- K252091 — Surgical Reality Viewer
- K252275 — Electric Scooter (DDF100)
- K252347 — Electric Scooter (Mojo-T580)
- K252349 — Electric Scooter (Mojo-T330)
- K252496 — Neurophet AQUA AD Plus
- K252684 — Labcorp Fentanyl Urine Visual Test
- K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- K253611 — Falco Fusion System
- K253632 — Manual Wheelchair (W50)
Data sourced from openFDA. This site is unofficial and independent of the FDA.