FDA 510(k) clearances — page 10
clearances on record, most recent first.
Clearances — page 10
901–1,000 of 175,620- K253573 — ASTar BC G- Kit
- K254107 — Refobacin Bone Cement R (110034355)
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K260129 — Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
- K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
- K260307 — Diode Laser Therapy Systems (V19)
- K260661 — Midas Restore
- K260722 — SureSmile Aligner (ASSY500020)
- K260938 — PATH BGC
- K240974 — SPRINT PNS System
- K252587 — HD 8Ch Wrist Array
- K252663 — Inbentus Versatile
- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
- K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm
- K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING
- K260583 — Equinoxe® Shoulder System
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252280 — Elecsys Anti-SARS-CoV-2 S
- K253357 — b-ONE® Bipolar Head
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253861 — ACORYS MAPPING SYSTEM
- K254078 — HVT 2.0
- K254128 — InSet Reverse Total Shoulder System
- K260091 — Aventus Introducer Sheath
- K260095 — Heal-Check Rapid COVID-19 Antigen Self-Test
- K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
- K260965 — CVAC Aspiration System
- K252190 — DeepBT Detector-Plus
- K252207 — ABL90 FLEX PLUS System, safeCLINITUBES
- K252241 — Pressio 3 Multi-parameter Neuromonitoring System
- K252250 — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K252548 — AI-Rad Companion Organs RT
- K252699 — CoAptix S System
- K252708 — Relu Cloud
- K252757 — CeQur Simplicity On-Demand Insulin Delivery System
- K252942 — ShaeferH
- K253361 — Teleport Glide Microcatheter
- K253446 — AeroDR TX c02
- K253510 — Freestyle Mini Hands-free
- K253657 — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
- K253689 — syngo Dynamics (VA41F)
- K253777 — Ascblue (8010)
- K253917 — ARION ARC System
- K253926 — Diacore
- K253930 — Overjet Iris Intelligent Imaging System
- K254004 — VRNT
- K260082 — TRIOS Dx (R1)
- K260090 — SMART Osteotomy System
- K260244 — Auryon Atherectomy System
- K260430 — Porcelain Etch Gel
- K260508 — LOBO Vascular Occlusion System
- K260839 — Protaryx Transseptal Puncture Device (PTX2-001)
- K252228 — Seaman Pro/Seaman
- K252251 — EASYMADE-TI
- K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
- K253975 — Radical 6F Access Catheter
- K254021 — Accuro XV
- K254158 — SPINEART Navigation Instrument System
- K260017 — Picosecond Nd:YAG Laser Systems (Model: HS-298)
- K260067 — Eternal Art Porcelain Powders
- K260245 — SILKBridge
- K260317 — Artelon Convenience Kits
- K260462 — RCT800
- K260555 — LOCATOR® Angled Abutment
- K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
- K251889 — myAir
- K252224 — Apex Locator (FindPex)
- K252270 — Hemoclip
- K253268 — Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
- K253534 — Pivot Insulin Delivery System
- K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
- K260033 — Wearable Breast Pump (Model S21A)
- K260089 — TL-10 Laparoscopic Scope Cleaner
- K260197 — Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
- K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
- K260477 — CATAMARAN SI Joint Fusion System
- K260766 — Celerity 5 HP Biological Indicator (LCB052)
- K260816 — OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
- K252116 — Firefighter Pro PTCA Balloon Catheter
- K252861 — Warming System
- K252979 — Voyager DSLT (430840610)
- K253801 — ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
- K253905 — PrimeSight UltraView System
- K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
- K253952 — Power Wheelchair (OS-R-M01S)
- K254191 — IWD-Gel
- K260046 — Elecsys Anti-HBc II
- K260048 — Elecsys Anti-HAV IgM
- K260049 — Elecsys Anti-HBc IgM
- K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
- K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
- K260942 — AuST Steerable Sheath
- K250208 — SPECTRA Wearable 2
- K252182 — SV70 Ventilator (SV70)
- K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- K252809 — in2 Smart (in2S)
- K253025 — Ricoh 3D for Healthcare Bolus
Data sourced from openFDA. This site is unofficial and independent of the FDA.