FDA 510(k) clearances — page 278
clearances on record, most recent first.
Clearances — page 278
27,701–27,800 of 175,699- K172506 — BD Cathena Safety IV Catheter
- K162482 — A.B. DENTAL DEVICES Dental Implants System
- K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair
- K163666 — neuro inspire
- K170231 — iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)
- K170417 — Glidewire GT
- K170527 — Phoenix Clinical ICON
- K170838 — Medentika CAD/CAM TiBases
- K171123 — Leksell Vantage Stereotactic System
- K171176 — M-CATH Microcatheter
- K171446 — Cefaly Acute
- K171519 — FLXfit
- K171652 — Fresenius Liberty Select Cycler
- K171686 — Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
- K171785 — WowGoHealth Blood Glucose Monitoring System
- K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console
- K172064 — Ti-Diagon Oblique TLIF
- K172150 — Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
- K172356 — BladderScan Prime PLUS System
- K172519 — PICO Single Use Negative Pressure Wound Therapy System
- K172522 — Mazor X
- DEN160018 — reSet
- K163148 — BePOD® Foot Screws
- K163209 — Fiagon Navigation System
- K163556 — MediClear PreOp
- K163627 — Shotel Ankle Arthrodesis Nail System
- K170168 — Masimo Rad-97 and Accessories
- K170323 — Entuit Start Initial Placement Gastrostomy Set
- K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit
- K170937 — VIPER PRIME navigated inserter
- K171378 — Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
- K171832 — Range/Denali/Mesa Spinal System
- K171953 — Bard Mission Disposable Core Biopsy Instrument
- K172120 — Veress Needle
- K172385 — Clarius Ultrasound System
- K172479 — Amsel Occluder Device
- K172481 — IntelliCart System
- K172513 — 3D Echo
- K163215 — AnemoCheck
- K171051 — HORIZON Therapy System
- K171201 — NeuViz Prime Multi-slice CT Scanner System
- K171359 — Pollogen Legend+ System
- K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- K172142 — FibroScan 430 Mini+
- K170185 — tremoFlo C-100 Airwave Oscillometry System
- K170409 — PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
- K170875 — da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
- K171144 — Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
- K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
- K171537 — CAPI 3 Hb A1c
- K171582 — NEO Pedicle Screw System
- K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System
- K170275 — Tri Auto ZX2
- K170368 — Sterile NS System
- K170487 — Navina Classic System
- K170596 — TN-Brush
- K170644 — da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
- K170645 — da Vinci Xi EndoWrist Instruments and Accessories
- K170822 — Electronic Caries Detector
- K171067 — INVISION Total Ankle Revision System
- K171189 — AIR-FLOW PLUS Prophylaxis powder
- K171317 — Clear Vinyl Powder-free Patient Examination Gloves
- K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
- K172117 — Prelude Pursuit Splittable Sheath Introducer
- K170047 — All-in-One Health Monitor, PC-303
- K163292 — Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
- K163465 — hemochroma PLUS System
- K163699 — ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
- K163710 — BePOD® EZ Weil Screws
- K170032 — QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
- K170415 — Medline Hemo-Force DVT Compression Sleeve
- K170704 — The Locking Pediatric Osteotomy Plate (LolliPOP) System
- K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
- K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
- K171330 — Nanova Sealant
- K171334 — Indego
- K171351 — Posterior Spine Truss System (PSTS) Interbody Fusion Device
- K171510 — Footmotion Plating System
- K171648 — BM.IRIS
- K171667 — Powder Free Nitrile Examination Glove
- K171725 — CuffLink Implant System
- K171805 — Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
- K171893 — Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
- K172170 — APTUS(R) Wrist 2.5 System
- K162171 — S4 Screw System
- K170041 — XableCath Support Catheter
- K170381 — Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
- K170442 — Cranial Drill Bits and Accessories
- K170855 — T-Rex Standalone ALIF
- K170981 — NeuroQuant
- K171126 — Implantium II
- K171730 — FuckWater
- K172433 — NICO BrainPath
- K172489 — Reliance Cervical IBF System
- K161586 — The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
- K163510 — Poseidon Ultrasound System
- K163538 — QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
- K171027 — Dentis Dental Implant System
- K171035 — Katalyst Mark 1 Muscle Stimulation System
- K171178 — Central Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.