FDA 510(k) clearances — page 24
clearances on record, most recent first.
Clearances — page 24
2,301–2,400 of 176,479- K253203 — Retrograde Coronary Sinus Perfusion Cannulae
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System
- K253623 — Spine Guidance 5.4 Software +9 more
- K253687 — Access anti-HBc Total
- K254018 — Portable Dental X-ray Device (GT-1)
- K254148 — VERTICALE GPS Instruments
- K254188 — Meniscus Versaflex
- K260163 — AuST CSP Introducer
- K260205 — AS Software Version Asera
- K260218 — LacertaMatrix
- K260308 — TrueFit Bolus
- K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
- K252197 — Nobel Biocare S Series Implants
- K252561 — BTL-754FF
- K253539 — Alere NT-proBNP for Alinity i
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- K253643 — Mobility Scooter (S3)
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
- K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- K251680 — Biosteon® Screw
- K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- K253524 — Adaptos®Fuse Bone Graft
- K253599 — Electric Wheelchair (W-A807, W-A807L)
- K254089 — IOPS Visionary System (MC-3) +7 more
- K260149 — Versus Catheter (VS110-9NB)
- K243854 — Contour Light (CL-100)
- K250233 — PreemptiveAI Clinical SDK
- K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
- K251619 — Babyleo TN500
- K251742 — VELO Respiratory Test
- K251802 — STAR RF Ablation System
- K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
- K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) +1 more
- K252400 — Endomina EZFuse system
- K252420 — Wearable Breast Pump (Model W12)
- K252422 — Wearable Breast Pump (Model W2)
- K252512 — Armada 14 NC PTA Catheter
- K252565 — PreOp v3
- K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
- K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
- K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
- K253092 — Argos Infinity (Rev. 1.0)
- K253096 — Chartis Precision Catheter
- K253133 — Wrist Blood Pressure Monitor (BPM-W1VL)
- K253149 — Motion InBra (YM-8801) wearable breast pump
- K253564 — uMI Panvivo (4 models)
- K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
- K254105 — Hive Standalone Cervical System and Hive C Interbody System
- K260130 — Willow 18 Guidewire
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251732 — Wrist Fracture System
- K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P))
- K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
- K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC
- K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS)
- K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
- K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
- K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
- 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 (5 models)
- K252175 — LANDR Contact LENS Case
- K252179 — GEM Flex Coil 16-L Array, 1.5T Receive Only +2 more
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.