FDA 510(k) clearances — page 295
clearances on record, most recent first.
Clearances — page 295
29,401–29,500 of 175,699- K163450 — VIVA combo RF System
- K163489 — OrthoSolutions 'System26' Bone Screws
- K163654 — VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
- K170095 — Vial2Bag Direct Connect
- K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
- K160067 — RenovoCath
- K160721 — Vado Steerable Sheath
- K161865 — iSage Rx (iSage Rx Basal Insulin Titration)
- K162311 — Straumann PrefGel
- K162870 — CIMLRE F1 and CIMILRE S3
- K162906 — Flexi-Seal PROTECT Fecal Management System
- K162919 — Male Latex Condoms
- K170346 — PRECICE Intramedullary Limb Lengthening System
- K170403 — CenterCross Ultra LV Catheter
- K162033 — SALVATION External Fixation System
- K162035 — GMK Sphere
- K162325 — Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
- K163188 — Next Science Wound Gel (Rx)
- K163436 — Greiner Vacuette Urine Count and Culture, Mannitol tube
- K170430 — TSolution One Surgical System Model 210
- DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests)
- K160345 — Glass Ionomer Cement
- K161918 — SREE MRI Transport Incubator
- K161991 — Curasite
- K162044 — Dentca Denture Base II
- K162524 — AZUR CX Detachable 18 Peripheral Coil System
- K162529 — DigiX FDX
- K162575 — Z-LINKPC System
- K162580 — Guardian Angel GA1000 Digital Vital Sign Monitoring System
- K162646 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
- K162746 — Ontex and other proprietary names
- K162947 — Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler
- K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3
- K163552 — iPulse SmoothSkin BARE Hair Removal Device
- K163575 — Inqwire Diagnostic Guide Wire
- K170058 — TheraView TBI
- K170164 — 3D OCT-1 Maestro
- K170167 — True 3D Viewer Software
- K170314 — ACL AcuStar
- K170331 — Cyber Ho
- K170350 — ToeMATE® Hammertoe Correction System
- K153538 — Dextramer CMV Kit
- K153688 — Edi Catheter ENFit
- K161304 — EndoPur Filter
- K161430 — Myoject Luer Lock Needle Electrode
- K161554 — ENDOFLATOR 40, ENDOFLATOR 50
- K161633 — REXLON, REXSIL
- K161737 — RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
- K161892 — Slimming Treatment Device
- K162199 — Cascade IOMAX Intraoperative Monitor
- K162356 — Vesair Cystoscopic Sheath
- K162364 — Intellijoint HIP Generation 2A System
- K162410 — TIPCAM 1S 3D System
- K162811 — MR Conditional CGA 870
- K163379 — KneeAlign 2 System
- K163497 — EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
- K170348 — Signia Four-Bay Smart Charger (to be used with Signia Stapler)
- K170355 — RayStation 6
- K170420 — n!ce Glass Ceramic Blocks for Amann Girrbach
- K162026 — EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
- K162383 — Cadwell Sierra Summit, Cadwell Sierra Ascent
- K163284 — syngo. CT Neuro Perfusion
- K170332 — DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
- K161655 — On1 Concept
- K162018 — Surface Applicator Set
- K162753 — RTC 26-C Inline Aerosol Adapter
- K162837 — Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System
- K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer
- K163038 — EPIC Extremity Snap-Off Screw
- K163234 — Biograph mMR with syngo MR E11P system software
- K163245 — Virtual Occupational Therapy Application (VOTA)
- K163282 — Apex Dental Sensors
- K163543 — Biomet Fusion System
- K163709 — FIRMap Catheter
- K170008 — Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
- K170105 — Jac-Cell Medic testers
- K170283 — BD Nexiva Diffusics Closed IV Catheter System
- K161853 — proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
- K162903 — Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
- K162982 — Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
- K163032 — Kyphon Xpede Bone Cement
- K163191 — ComfortGuard Surgical Gown, i600, Film Reinforced
- K163591 — BD PosiFlush Heparin Lock Flush Syringe
- K170373 — Flextra Steerable Introducer
- K160358 — DT-100
- K160857 — HF 718BD X-Ray System
- K161371 — Sonoma Fifth Metatarsal Repair System
- K161372 — The Red Head Collection Device, The Jordy Connection System
- K161484 — ZIIP Device
- K161579 — Watch-PAT200U
- K161859 — MagnetOs
- K161860 — TG-970P CO2 Sensor Kit
- K162071 — IllumiFlow Laser Cap
- K162073 — Dental Implants OKTAGON Tissue Level and Bone Level
- K162393 — The ViewRay (MRIdian) Linac System
- K162752 — ARTIA Reconstructive Tissue Matrix Perforated
- K162771 — EkoSonic Endovascular System with Control Unit 4.0
- K162888 — Cercon
- K162916 — 3NT endoscopy system
- K162989 — Rusch Simplastic Foley Catheters
Data sourced from openFDA. This site is unofficial and independent of the FDA.