FDA 510(k) clearances — page 212
clearances on record, most recent first.
Clearances — page 212
21,101–21,200 of 175,699- K192964 — Parcus Synd-EZ SS
- K193017 — EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
- K193031 — EXPD 4343P, EXPD 3643P
- K193036 — C2 CryoBalloon EndoGrip
- K193041 — Hemochron Signature Elite
- K181839 — CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
- K190439 — Engage Partial Knee System
- K191464 — Asahi PTCA Guide Wire Asahi SION Series
- K191488 — SAM IO Intraosseous Access System
- K192061 — SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
- K192124 — Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
- K192266 — M. Blue Adjustable Shunt System
- K192299 — LZI Cotinine II Enzyme Immunoassay
- K192480 — Torpedo Gelatin Foam
- K192592 — Axis Plating System
- K192625 — PG Pro Microcatheter
- K192996 — Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
- DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System
- K181953 — SDS1.2 dental implant
- K190497 — Ziehm 8000
- K191865 — SmartLite Pro Modular LED Curing Light
- K192281 — AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
- K192664 — FUJIFILM Endoscope Model EC-760Z-V/L
- K192672 — uPMR 790
- K192792 — TranS1 AxiaLIF Plus System
- K192955 — Penumbra LP Coil System
- K182979 — IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
- K190816 — Vial Adapter Ø20 mm , Vial Adapter Ø13 mm
- K191278 — RSI-MRI+
- K192204 — Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
- K192269 — TwinScan 808/755 Laser System
- K192292 — L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
- K192573 — Dolphin Medical Imaging USB Ultrasound System
- K192643 — Dannik Laparoscopic Suction Irrigation System
- K182732 — JTL-250-01
- K182917 — FluoroCal
- K183393 — Digital Thermometer
- K190797 — Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
- K191980 — CLEARFIL MAJESTY ES Flow
- K192323 — PolyLock Small Bone Plating System
- K192769 — Impella CP Introducer
- K192937 — 3M Comply Hydrogen Peroxide Chemical Indicator
- K182672 — ROSA Bracket
- K183598 — KeyPrint KeySplint Soft
- K190312 — Dornier Ureteral Stent
- K190391 — TDM Plate and Screw Systems
- K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
- K191201 — EM SA Implant System
- K191247 — SmartSPACE Shoulder System
- K191701 — Arcus Head Fixation Frame
- K191784 — Gabriel Feeding Tube with Balloon, and EnFit Connector
- K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
- K192045 — Ophthalmic Yag Laser System YC-200
- K192113 — DRSplus
- K192174 — SPY Portable Handheld Imaging (SPY-PHI) System
- K192245 — Pentax Medical Video Duodenoscope ED34-i10T2
- K192289 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
- K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
- K192935 — CAPERE Thrombectomy System
- K192936 — Soltus 500
- K192940 — CoolTone
- K183666 — EBA One Nailing System
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
- K190721 — LongBow Ti
- K191110 — HeraBEAT US
- K191280 — E-100 Electrosurgical Generator, SynchroSeal
- K192347 — ST Internal Implant System
- K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
- K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
- K192911 — Brainlab Compatible K2M Navigation Instruments
- K191171 — EchoGo Core
- K191477 — AEON-C Stand Alone System
- K191570 — Infrared Thermometer Model MD-H30
- K191976 — Piper GO-IO Intraosseous Infusion System
- K192150 — AMICUS Separator System
- K192469 — Nox Sleep System
- K192582 — NuVasive CoRoent Small Interlock System
- K192915 — GMA 2.0 Pedicle Screw System
- K190799 — PENTAX Medical Video Upper GI Scopes (EG Family)
- K191161 — xTAG Gastrointestinal Pathogen Panel (GPP)
- K191972 — ARIX Wrist System
- K192202 — Clear21
- K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)
- K192331 — LaseMD LEO Laser System
- K192932 — FDR D-EVO III flat panel detector system
- K192968 — IDENTIFY
- K191986 — DESS Dental Smart Solutions
- K192661 — LATERA Absorbable Nasal Implant System
- K190661 — Omics Core
- K190958 — Neodent Implant System
- K182301 — PFC SIGMA Knee System
- K190998 — BA Pit & Fissure Sealant
- K191230 — Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
- K191237 — CERENOVUS Large Bore Catheter
- K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- K191286 — CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System
- K191527 — Visalys CemCore, Visalys Cem Core Try In Paste
- K191959 — QuantX Breast MRI Biopsy Guidance Plugin
- K192019 — Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1
Data sourced from openFDA. This site is unofficial and independent of the FDA.