FDA 510(k) clearances — page 163
clearances on record, most recent first.
Clearances — page 163
16,201–16,300 of 176,479- K212793 — Laser Treatment System, Model: Hera, Armo
- K213085 — Introcan Safety 3 Closed IV Catheter
- K213386 — Titan Manufacturing Bipolar Forceps
- K210348 — Disposable Medical Surgical Mask
- K211509 — Surgical Gown
- K211698 — Vinyl Examination Gloves(Yellow)
- K212368 — Surgical Face Mask
- K202120 — P300 Attachment
- K210310 — CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
- K210424 — Quantum Anterior Cervical Plate
- K210807 — FlightPlan for Liver
- K211186 — Erchonia XLR8
- K211735 — CO2 Laser Machine, Model: BW-203B
- K211775 — Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
- K211819 — DiLumen C2 and Tool Mount
- K212061 — EnSite X EP System
- K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer
- K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
- K212396 — UroLift System Rigid Retrieval Kit Sterilization Tray
- K212399 — Aveli
- K212516 — IRNF App
- K212666 — Neuromark System
- K200545 — Legend Pro DMA
- K210322 — XO Cross Support Catheter
- K210928 — PENTAX Medical Video Bronchoscope EB11-J10
- K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
- K211407 — Belun Ring BLR-100X
- K211415 — GR Splint Resin System
- K211526 — Portable Scalp Cooling System
- K212270 — DEKA LipoAI
- K212311 — Medical Examination Gloves
- K212314 — IPL Hair Removal Device
- K213028 — Tenax Laser Resistant Endotracheal Tube
- K213036 — Treace Medical Concepts (TMC) Screw Fixation System
- K213113 — Orthoscan Tau Mini C-Arm
- DEN210005 — Luminopia One
- K200865 — Piccolo Potassium Test System
- K203808 — Multi-unit Abutment, Multi-unit Angled Abutment
- K210177 — PENTAX Medical Video Upper GI Scopes EG17-J10
- K210511 — InTray GC
- K210618 — Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
- K210632 — Contour ProtegeAI
- K210789 — EQ-PEX
- K211672 — MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
- K211921 — S.I.N. Dental Implant System
- K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K212470 — iRAD
- K212490 — AVVIGO Guidance System II
- K192746 — MyoWorx TM20
- K201773 — PICOHI
- K202982 — Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
- K203565 — Surgical 3D Mask
- K210124 — Synergy Gold (SG) Portable (Models MM011450 and MM011460)
- K210204 — Capsule Vitals Plus Patient Monitoring System
- K210706 — Nitrile Examination Gloves
- K210911 — WOLF Thrombectomy System, 14F
- K211035 — U9000 Plus Ultrafilter
- K211084 — Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
- K211170 — Single Use Irrigation bipolar cable
- K211564 — Sterile High-pressure Angiographic Syringes for Single-use
- K212254 — DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
- K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories
- K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle
- K201017 — BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
- K211555 — Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
- K211582 — LOQTEQ Proximal Humerus Plate 3.5 System
- K211809 — Surgical Gown
- K212528 — Change Healthcare Cardiology
- K212632 — ClotTriever Thrombectomy System
- K212753 — 0909FCB, 1212FCA
- K201880 — MultiSure GK Link Blood Glucose and Ketone Monitoring System
- K202433 — Aqueduct 200 Cervical Dilation Balloon Catheter
- K210563 — Arm Blood Pressure Monitor
- K211091 — Deka Tiac II
- K211224 — RM4 Control Unit
- K211403 — HIVOX OTC Electrical Stimulator, FT610-B
- K211992 — Ortho MI System
- K212517 — Magicore System
- K212593 — ViaCath, AcQRate Dx Steerable Catheter
- K212636 — CORUS Spinal System-X
- K212959 — ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
- K212967 — AxTiHA Stand-Alone ALIF System
- K202688 — AFS Medical Sterile Single-Use Access Port System
- K202808 — Brainance MD
- K210231 — Vittra APS Unique
- K210999 — SwiftMR
- K211121 — Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
- K211147 — ALGO 7i
- K211214 — Sterile Hypodermic Needles for Single Use
- K211461 — Family of Venus RF Systems - Venus Freedom
- K211753 — Sterile Syringe With Safety Needle
- K211807 — Sapphire NC 24
- K211914 — Nitrile Patient Examination Gloves
- K212205 — Medical Protective Masks
- K212261 — StrokeSENS LVO
- K213002 — SCORPION Portal Vein Access Set
- K210116 — Video Endoscopy System, 3D Video Endoscopy System
- K211374 — Proclean - Nitrile Powder Free Examination Gloves
- K211801 — SPRINT PNS System
Data sourced from openFDA. This site is unofficial and independent of the FDA.