FDA 510(k) clearances — page 287
clearances on record, most recent first.
Clearances — page 287
28,601–28,700 of 176,542- 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
- K171496 — Tritanium C Anterior Cervical Cage
- K172372 — QuadraSphere Microspheres
- K172375 — MicroSTAAR Injector System Cartridges
- K172394 — Steerable Guide Catheter
- K163464 — Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
- K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System
- K172048 — FluidSmart
- K163302 — Senographe Pristina
- K163338 — OMNIBotics Knee System
- K163439 — NaviENT
- K163448 — GrindCare System
- K170181 — Prizma
- K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
- K170547 — Arthrex Mesh Plate System
- K170970 — Epilaser
- K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000)
- K171323 — BIOPHOTAS CELLUMA3
- K171358 — Emprint SX Ablation Platform and Accessories
- K171507 — CustomizedBone Service
- K171558 — ExsoMed ITN Cannulated Screw System
- K171583 — RhythmView Workstation
- K162533 — Kelowna GYN and Crook Prostate Templates
- K162613 — Integrated Catch-up Freedom Syringe Driver Infusion System
- K163337 — Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
- K163402 — NLZ Motor System
- K163423 — Orthopantomograph OP300
- K170031 — Internal Octa Implant System
- K170599 — SureFlo EVD Catheter
- K171010 — Latitude EV Total Elbow Arthroplasty
- K171224 — Arctic Sperm Cryopreservation Medium
- K171570 — Additional VIPER PRIME screws with fenestrations
- K171642 — Atellica IM Ferritin Assay
- K171704 — CAPRI Corpectomy Cage System
- K171791 — MAGEC® System
- K172033 — Pirouette High Pressure (HP)
- K172055 — DUS-7000 Digital Color Doppler Ultrasound System
- K172098 — Medical Video Endoscope System
- K172106 — SHOFU MZ Primer Plus
- K163485 — SmartTouch
- K163628 — Idylla Respiratory (IFV-RSV) Panel
- K170467 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K170564 — MyndMove System, MyndMove Functional Electrical Stimulator
- K171321 — K2M Navigation Instruments
- K171540 — Refobacin Bone Cement R
- K171626 — truFreeze System
- K171985 — Astroglide O Oil Personal Lubricant & Massage Oil
- K172021 — LigaPASS
- K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
- K172274 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
- K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- K162943 — SyMRI
- K163385 — Cortex Dental Implant System
- K170958 — ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
- K171039 — Assut Filbloc Permanent Sutures
- K171329 — Altus Spine Titanium Interbody Fusion System
- K171506 — Easyscreen
Data sourced from openFDA. This site is unofficial and independent of the FDA.