FDA 510(k) clearances — page 220
clearances on record, most recent first.
Clearances — page 220
21,901–22,000 of 176,542- K192745 — DePuy Synthes Trauma Screws
- K192764 — NeuroOne Cortical Electrode
- K192907 — Advocate PTA Catheter
- K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis
- K192946 — DePuy Corail AMT Hip Prosthesis
- K181845 — Pivot System Sterilization case
- K190494 — Infant Incubator
- K190529 — SOZO
- K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
- K191851 — VS3-IR
- K192248 — Cortina [MAX] Lumbar Cage System
- K192329 — Blue Latex Examination Powder Free Gloves
- K192788 — ADVIA Centaur Cortisol (COR)
- K182712 — DEXIS CariVu 3-in-1 by KaVo
- K190760 — Cadwell Bolt Software
- K171899 — Revitalair 430F
- K190331 — Applied Medical Laparoscopic Linear Cutter
- K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
- K190518 — Color Liquid, Vita Liquid
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- K190977 — Navina Smart System, Navina Classic System
- K191028 — KLS Martin Individual Patient Solutions
- K191075 — Healy
- K191103 — Parkell Desensitizer Gel
- K191236 — 3M Attest Steam Chemical Integrators
- K191734 — MatriStem UBM Pericardial Patch
- K191746 — SMR TT Augmented Glenoid System
- K191754 — Hair Growth System
- K191903 — BruxZir GT (Gum Tissue) Color
- K192122 — Trevo Trak 21 Microcatheter
- K192126 — AMIStem-P Short Neck
- K192157 — 6450 Ultrasound system
- K192207 — Trevo NXT ProVue Retriever
- K192242 — Synergy Platform, Synergy, Infinity, VersaHD
- K192260 — everX Flow
- K192270 — LEva Pelvic Digital Health System
- K192336 — Navigated Anterolateral Disc Prep Instruments
- K192508 — Medsynapse Ris Pacs & Medsynapse VNA
- K192603 — Spes Medica Subdermal Needle Electrodes
- K192675 — VariAx Foot
- K192777 — ADVIA Centaur CA 15-3 assay
- K192843 — INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
- K192877 — Senhance Surgical System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.