FDA 510(k) clearances — page 207
clearances on record, most recent first.
Clearances — page 207
20,601–20,700 of 176,479- K200444 — Biomonitor III, Biomonitor IIIm
- K200666 — Stryker Xia 3 Power Adaptor
- K200705 — Nurochek System
- K200762 — CoLink Cfx Plating System
- K200787 — BSD3543W
- K200847 — Surgical Face Mask
- K190984 — Infrared Forehead Thermometer
- K191882 — Masimo Centroid System
- K191997 — FAICO CMF System
- K192517 — Psychemedics Microplate EIA for Cotinine in Hair
- K200168 — Dermapose Access
- K200185 — SYLFIRM X
- K200585 — Acuson SC2000 Diagnostic Ultrasound System
- K200752 — DB-Orthopedics
- K200771 — Indigo Aspiration System Lightning Aspiration Tubing
- K192034 — HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
- K192082 — Droplet Pen Needle 34G
- K192145 — Galileo Vertebral Body Replacement Device
- K192492 — EL CAPITAN Anterior Lumber Interbody System
- K192609 — Globalcare Blood Pressure Monitor
- K192701 — DIBS (Digital Indirect Bonding System)
- K193074 — Bevel Up Holder
- K193161 — Pristine Scope
- K193351 — NinesAI
- K200053 — DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
- K200162 — Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
- K200744 — Instylla Microcatheter
- K200745 — Lariat, Hot/Cold Snare
- K192154 — Rio Vial-to-Bag Drug Reconstitution Device
- K192382 — CapKlenZ
- K193032 — KY Grosz Liquid
- K193197 — QuickClear Mechanical Thrombectomy System
- K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
- K200024 — uMR 570
- K200122 — MOTO PFJ System
- K200559 — CarpX
- K200600 — Sentinel
- K191995 — S4 Screw System
- K200121 — Route 92 Medical 088 Access System, 110 cm
- K191720 — BRUIS Software Suite
- K192552 — Irradiation Cosmetic Device
- K200118 — Diode Laser Therapy Device
- K200158 — LOGIQ E10
- K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K200338 — ProLift Lateral Fixated
- K200709 — Kyocera Bipolar Hip System
- K200712 — Rumble Tuff Electric Breast Pump
- K200733 — Opticross 35 15 MHz Peripheral Imaging Catheter
- K200868 — SI-Restore Sacroiliac Joint Fixation System
- DEN190028 — MyCare Psychiatry Clozapine Assay Kit
- K192875 — Philips Biosensor BX100
- K193124 — Unicel DxH 800 Coulter Cellular Analysis System
- K193326 — ARTIS Icono
- K193549 — SIGMA High Performance (HP) Partial Knee System
- K193588 — DD Contrast
- K200547 — Traxcess 14 SELECT Guidewire
- K200670 — EON Portable RO Water Purification System
- K200729 — HydroCision SpineJet System
- K200755 — Caption Guidance
- K191930 — 7 mm Extended Length Endoscope
- K192588 — G-EYE System
- K193181 — Serranator PTA Serration Balloon Catheter
- K193373 — Comprehensive® Reverse Shoulder
- K193534 — Monarch Platform
- K193561 — Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
- K200092 — 3MTM AttestTM Mini Auto-reader 490M
- K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K200500 — Molekule Air Pro RX
- K200613 — Tritanium® X TL Expandable Curved Posterior Lumbar Cage
- K200625 — I-View Gold and Imagen Gold Dental Sensors
- K200707 — ACUSON Sequoia Diagnostic Ultrasound System
- K200887 — AS-10
- K182400 — Solax Powered Wheelchair (Models: S7101, S7103)
- K191353 — COMET Lumbar Interbody Fusion Cage
- K191654 — SILICONE Personal Lubricant
- K191803 — Orthopedic Fixation Pin
- K192781 — UroLift System Procedure Kit Sterilization Tray
- K192982 — KY Grosz UltraGel
- K193349 — Vapocoolshot Mist
- K193363 — Dermapose Refresh
- K193369 — Xelis Dental 2.0
- K200388 — Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
- K200403 — Stat Profile Prime Plus Analyzer System
- K200703 — JiveX
- K192167 — CuraRad-ICH
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- K192850 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
- K193464 — ND:YAG Laser
- K200099 — s-Clean SQ-SL Implant System Mini
- K200215 — ADVIA Centaur CEA Assay
- K200300 — VivAer Stylus
- K200726 — AcuityPDR
- K200665 — VERASENSE for Stryker Triathlon
- K193275 — Nerve and Muscle Stimulator
- K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
- K192679 — Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
- K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
- K193282 — SIGNA Premier
- K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
- K200044 — SkinStylus SteriLock MicroSystem
Data sourced from openFDA. This site is unofficial and independent of the FDA.