FDA 510(k) clearances — page 290
clearances on record, most recent first.
Clearances — page 290
28,901–29,000 of 175,699- K162952 — C.T.M. Mobility Scooter
- K163481 — HALF DOME Posterior Lumbar Interbody System
- K163530 — PrisMax Control Unit
- K163640 — QZA and RS Dental Implant Systems
- K163683 — A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
- K170107 — Surgi Max Ultra
- K170269 — Hee HR Mini
- K170440 — KISSloc Suture System
- K170718 — Iridex TruFocus LIO Premiere
- K170977 — SURESHOT Distal Targeting System V4.0 Trauma Interface
- K171005 — Silhouette Featherlift
- K160781 — Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
- K161790 — iGlucose Blood Glucose Monitoring System
- K162041 — Airworks Nebulizer pe1200m
- K162380 — Locking Plate System
- K163621 — Vitoss Bioactive (BA) Injectable
- K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test
- K170108 — Xultan 5.5 Pedicle Screw System
- K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K170308 — BD MAX Extended Enteric Bacterial Panel, BD MAX System
- K170360 — NAVIO
- K170364 — Collagen Meniscus Implant XL
- K171098 — AXIS Image Management System
- K162266 — The Cranial Fusion System
- K162303 — REDAPT Sleeved Monolithic Revision Stems
- K162620 — Remel Spectra ESBL
- K162647 — NuVasive NuvaLine Mobile App
- K162751 — Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
- K162825 — CAPTIVATE Compression Screws
- K163119 — NaviSuite SSI Edition
- K163707 — NuVasive CoRoent Ti-C System
- K170011 — StealthStation S8 Spine Software v1.0.0
- K170114 — MagVita TMS Therapy - w/MagPro R20
- K170291 — IontoDC
- K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval
- K170334 — XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
- K170733 — ScanX Intraoral View
- K170777 — Bovie J-Plasma Precise FLEX Handpiece
- K170975 — Televere Digital Imaging System
- K170145 — Digital TENS Unit
- K161596 — Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
- K161724 — Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)
- K161857 — Salvin Tenting Screw System
- K162120 — Scope-Assist Flushing Sink
- K162159 — VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
- K162200 — Randox RX Daytona Plus Magnesium (MG)
- K162258 — Self Sealing Sterilization Pouches
- K162319 — BabyDance Fertility Lubricant
- K162460 — WAVi Headset and WAVi eSoc Single Use Electrode Contacts
- K162679 — IOB Temperature Management System
- K162945 — VERIFY ASSERT STEAM Process Challenge Device
- K163358 — Introcan Safety 3 Closed IV Catheter
- K163667 — RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
- K170070 — VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
- K170273 — Z-DOSE29
- K170280 — Smith & Nephew SURESHOT Distal Targeting System V4.0
- K170616 — van Andel Dilatation Catheter
- K170882 — ABL90 FLEX, ABL90 FLEX PLUS
- K170926 — BrainPulse 1100
- K170945 — Biodesign Staple Line Reinforcement
- K170951 — CardioCel 3D
- K170952 — syngo.CT View&GO
- K171045 — Exactech® Truliant Line Extensions
- K160730 — Instrument kits
- K161450 — HAMILTON-C3
- K162142 — Accessory Irrigation Adapter
- K162334 — U.S. Laser Worx Patriot 1 family of lasers
- K162385 — RAPIDEC CARBA NP
- K170211 — Insight Dental System
- K170220 — OneQ-SL s-Clean Implant System
- K170905 — Star Tissue Marker
- K170930 — RSM 2430C
- K170949 — RadiForce MX315W
- K162271 — Pro-Lock CT Safety Infusion Set
- K162732 — Exactech® Alteon® HA Femoral Stem
- K163149 — VisualEyes
- K163332 — Apex Revision Knee System
- K170069 — AmCAD-UV
- K170300 — Restrata Wound Matrix
- K170572 — Summit Spine Yellowstone Lumbar Interbody Fusion System
- K170592 — NuVasive BASE Interfixated Titanium System
- K170889 — HV Screw System
- K170938 — CalSet IGF-1
- K170942 — The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems
- K170964 — Zenius Spinal System
- K160670 — ET US SS Prosthetic system
- K162237 — XO1 Knee Balancing System
- K162661 — SavDenTM MTA Root Canal Filling Materials
- K162799 — Cliniview
- K163507 — Triton Sponge System
- K163675 — Processor VP-7000, Light Source BL-7000
- K170132 — MyoCycle Home, MyoCycle Pro
- K170260 — BC-001+ Acne Purifier
- K170511 — NeoFuse HA Enhanced PLIF/TLIF
- K170936 — Cutera enlighten III Laser System
- DEN160030 — Oculeve Intranasal Tear Neurostimulator Device
- K160499 — Apnea Risk Evaluation System (ARES), Model 620
- K162067 — VX130 Ophthalmic Diagnostic Device
- K162104 — C-Flex Ureteral Stent Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.